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By Alan, on May 17th, 2023  Child receiving vaccine patch in clinical trial (Micron Biomedical) 17 May 2023. A clinical trial shows a peel-and-stick patch device is as effective as a standard syringe injection in delivering a vaccine that protects against measles and rubella. Results of the trial sponsored by Micron Biomedical Inc. in Atlanta, the device developer, are presented today at the Microneedles 2023 conference in Seattle.
Micron Biomedical says its adhesive patch is designed to provide a simple, painless alternative for administering vaccines and therapies, particularly for children and others with a fear of needles. The company says the peel-and-stick patch offers other useful features for clinics and public health, notably storage and transportation without refrigeration, ease of administration even at home without supervision from trained specialists, and greatly reduced medical waste.
Micron Bio says the patch contains microscale needles that penetrate only the most outer skin layers and rapidly dissolve, releasing their payloads into blood capillaries within a few minutes. Once in the blood, says the company, the microneedle contents generate a response from immune cells in the outer skin layers. Micron Bio says the patch can deliver active live biologics, inactivate compounds, small molecule drugs, nucleic acids, peptides, proteins, and nano- to micro-scale particles.
The Micron Biomedical technology is based on research at Emory University and Georgia Tech in Atlanta. In June 2017, Science & Enterprise reported on results of a clinical trial testing a prototype stick-on patch to deliver influenza vaccine, showing the device is safe and produced an immune response. The trial was led by Emory infectious disease professor Nadine Rouphael and Georgia Tech biomedical engineering professor Mark Prausnitz who study alternative vaccine delivery methods. Prausnitz is co-founder and chief scientist of Micron Biomedical, as well as a serial entrepreneur.
Protective levels of antibodies
The new early- and mid-stage clinical trial tested the Micron Bio patch for delivery of a vaccine against the viral diseases measles and rubella, also known as German measles but caused by a different virus. The study team from Centers for Disease Control and Prevention (CDC) and the Medical Research Council of The Gambia in West Africa enrolled 45 adults, 120 infants from 9 to 10 months old, and 120 toddlers age 15 to 18 months. The researchers cite data from World Health Organization that show in lower resource regions, measles-rubella vaccine coverage continues to be well below recommended levels.
Participants were randomly assigned to receive a commercially available measles-rubella vaccine in age-appropriate doses made by Serum Institute of India, either with the Micron Biomedical patch or conventional under-the-skin injection, or a placebo. The study team looked primarily for signs of adverse effects within the first 14 days after vaccination, as well as six months later. In addition, the researchers are taking blood samples six weeks and six months after vaccination, for concentrations of immunoglobulin G or IgG antibodies that protect against measles and rubella.
The conference paper reports on findings at the six-week mark following vaccination. Results show the measles-rubella microneedle patch recipients with no allergic reactions nor serious adverse effects from the patch. In addition, the findings show adult and children patch recipients developing antibodies, including at protective concentrations, at rates of 90 to 93 percent, similar to concentrations generated by injections.
In a company statement released through Cision, Micron Biomedical CEO Steven Damon calls the results, “a major milestone in the future of injection-free administration of necessary and potentially life-saving vaccines and therapeutics.” Edward Clark, head of immunology at The Gambia Medical Research Council, adds the results “show, for the first time, the potential for microarray patches to safely and effectively deliver vaccines to children.”
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By Alan, on May 16th, 2023  (Public Domain Pictures, Pixabay) 16 May 2023. A developer of ultrasound bubbles to assist gene therapies is studying use of the technology with Janssen Pharmaceuticals for delivering DNA and RNA treatments. Financial and intellectual property details of the agreement between SonoThera Inc. in South San Francisco and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, were not disclosed.
SonoThera is a one year-old biotechnology start-up adapting ultrasound technology to help deliver gene therapies throughout the body. Ultrasound employs high-frequency sound waves to penetrate through the skin, and has become a widely used technique for non-invasively diagnosing disorders such as heart disease and picturing a fetus in the womb, in real time and without radiation.
SonoThera seeks to extend ultrasound use to gene therapies, which the company says are limited by current delivery methods. In many cases today, notes SonoThera, gene therapies are delivered with benign viruses that are often complex and expensive, have a small payload capacity and limited cell or tissue targets, and while harmless to many people may still cause an immune reaction in some patients. Non-viral gene therapy delivery methods, adds the company, are so far inefficient and time-limited in effectiveness, as well as poorly targeted and toxic in some cases.
Larger and wider range of payloads
SonoThera says its technology uses ultrasound to create microscale bubbles in a process called sonoporation that increases the uptake of gene therapies through cell membranes. The company says its process can deliver larger and a wider range of genetic payloads, and to more organs in the body than most other gene therapy delivery methods. In addition, the demonstrated safety of ultrasound for diagnostics increases the number of patients who can receive gene therapies. In June 2020, Science & Enterprise reported on an academic lab conducting preclinical research that demonstrates ultrasound assisting genetic immunotherapy deliveries in lab mice induced with solid-tumor cancers.
The agreement with Janssen Pharmaceuticals calls for the companies to jointly research ultrasound to help deliver nucleic acids such as DNA and RNA payloads to organs other than the liver. “We remain deeply committed,” says SonoThera co-founder and CEO Kenneth Greenberg in a company statement released through Cision, “to developing genetic medicines targeting organ systems which pose significant delivery challenges using existing gene therapy modalities and look forward to further accelerating key programs within our non-viral gene therapy platform development through this collaboration.”
While SonoThera is only about a year-old, the company already has a firm relationship with Janssen and its Johnson & Johnson parent. Before founding SonoThera, Feinberg was senior director for external innovation at Janssen R&D. Also, in December 2022, SonoThera raised nearly $61 million in its first venture round, with Johnson & Johnson Innovation taking part in the financing. Plus, SonoThera says Johnson & Johnson Innovation helped arrange for the new collaboration with Janssen Pharma.
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Disclosure: The author owns shares in Johnson & Johnson.
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By Alan, on May 15th, 2023  (Seanbatty, Pixabay) 15 May 2023. A company offering a search engine to help diagnose rare diseases is integrating generative models from Open AI into its artificial intelligence algorithms. The company FindZebra ApS in Copenhagen, Denmark is based on research by computer scientist Ole Winthur at Technical University of Denmark, or DTU, its scientific founder.
The FindZebra search engine was first introduced in 2013 to help medical professionals include rare diseases in their diagnoses from symptoms reported by patients. Up that time, says FindZebra, Google and even PubMed search inquiries on their own returned few results featuring rare diseases, also called orphan diseases. A 2021 study finds between 5,000 and 8,000 rare diseases in the world, with about 80 percent of genetic origin. The Orphan Drug Act defines rare diseases in the U.S. as those affecting fewer than 200,000 people in the country, but the number of individuals with a rare disease is estimated at 30 million, or one in 10 Americans.
Winthur and colleagues at DTU study machine learning with algorithms using neural network statistical models that process large volumes of data, applied to a range of disciplines including bioinformatics. FindZebra says its algorithms process symptom descriptions and other clinical information with freely available medical databases and open-source retrieval software, to return possible rare disease and genetic origin matches.
GPT trained further by humans
Open AI is a developer of artificial general intelligence systems or generative A.I. based on large language models. These models use deep learning techniques that emulate human brain functions to reveal underlying relationships in the data, often trained by large-scale databases. Generative A.I. makes possible text and data summarization and prediction in understandable human language. Open AI’s recent release of ChatGPT, a conversational generative A.I. engine, has become an introduction to A.I. for a large segment of the population.
An Open AI product getting less attention is InstructGPT that uses large language models, but trained further by human interactions, called reinforcement learning from human feedback, to follow instructions. Open AI says it uses InstructGPT to improve the safety of its ChatGPT A.I. products and reduce toxic outputs. In a paper submitted last year and revised in Jan. 2023 but not yet peer-reviewed, Winthur and associates combined InstructGPT and Codex, an Open AI system for code creation, to answer conversational medical questions in a chain-of-thought or step-by-step conversation. The results from 100 medical exam samples show the system can provide close to human-level performance, from 60 to 78 percent, on three different databases.
FindZebra says its search algorithms now access deep learning functions with an application program interface or API into Open AI’s GPT large language models. An API is code with a defined set of rules that enable different software packages to communicate and share data. Software companies often publish APIs to encourage integration of their software with customers.
Winthur believes the integration of GPT with FindZebra will be a transformative step for diagnosing rare diseases. “As the digital landscape evolves,” says Winthur in a FindZebra statement released through Cision, “it’s important that we persist in our innovation and improvement of our technology to ensure those affected by rare diseases have access to reliable and accurate information. The application of OpenAI’s cutting-edge GPT technology will aid us in this endeavor, making a significant impact on countless lives.”
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By Alan, on May 13th, 2023  Click on image for full-size view (Crunchbase) 13 May 2023. Despite a sharp downturn in venture dollars from 2021, new climate and weather forecasting companies continue to attract investments at historically high rates. Data compiled by Crunchbase show climate and weather analytics start-ups worldwide raised $266.5 million in 2022, an annual number exceeded only by the whopping $541.7 million in 2021.
Crunchbase also reports a total of 39 global venture deals for climate and weather forecasting start-ups in 2022, down slightly from the 44 deals in 2021, which suggests continued interest by venture investors in this sector. Before 2021, the largest dollar volume invested in weather and climate analytics companies was $145.6 million in 2017 and the largest number of annual deals, 27, occurred in 2020.
Companies in this sector, says Crunchbase, develop more sophisticated forecasting models than common weather apps found on mobile phones, often using artificial intelligence algorithms. The continuing degradation of the global climate and increasingly severe weather patterns are creating a larger market for these services, beyond earlier business customers in agriculture and energy, to companies in the housing and consumer goods industries.
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By Alan, on May 12th, 2023  (Gerd Altmann, Pixabay) 12 May 2023. An organization seeking new uses for today’s drugs and a contract research company aim to increase the number of clinical trials for rare diseases testing already approved drugs. The collaboration joins Every Cure, a not-for-profit group in Philadelphia that promotes new uses for approved drugs on the market, with Worldwide Clinical Trials, a contract research organization or CRO in Research Triangle Park, North Carolina conducting clinical studies and analytical services.
Every Cure was formed in 2022 in a partnership with the Clinton Global Initiative to find new applications for drugs already approved by the Food and Drug Administration, particularly for rare diseases. The group says it’s developing an open-source system with large-scale databases and analytics based on artificial intelligence algorithms to predict the efficacy of some 3,000 approved drugs against an estimated 9,000 other diseases with as yet no approved treatment.
The organization cites the experience of its co-founder David Fajgenbaum, a physician-scientist diagnosed with the rare disorder Castelman’s disease while in medical school, but successfully treated with an inexpensive drug approved years earlier for preventing immune rejection by kidney transplant patients. The group says it seeks to break through antiquated industry practices, such as restrictive data silos that make it difficult to identify additional uses for current drugs, particularly those with generic versions at lower cost. Every Cure’s Roadmap project — short for Repurposing Of All Drugs, Mapping All Paths — identifies potential paths for repurposing current drugs to treat rare diseases.
Trials to test approved generics against rare diseases
Worldwide Clinical Trials conducts clinical studies at all phases under contract to sponsoring companies and organizations. The company says it can organize trials in a range of disease types, including rare diseases, as well as offer bio-analytical services and research from real-world data sources. Rare diseases are defined as disorders affecting fewer than 200,000 individuals in the U.S., or five in 10,000 people in Europe.
Under the new collaboration, Worldwide Clinical Trials is serving as the clinical study practice partner for Every Cure, but financial and intellectual property details of their agreement are not disclosed. Worldwide Clinical Trials is providing its clinical research expertise in rare diseases to organize trials of generic drugs already approved for other conditions identified by Every Cure’s analytics and algorithms. “The combination of Every Cure’s computational A.I. algorithm,” says Fajgenbaum in a Worldwide Clinical Trials statement, “with Worldwide’s clinical trial expertise will have a substantial impact on finding and advancing cures for years to come.”
“Every Cure’s method,” notes chief operating officer at Worldwide Clinical Trials Dave Bowser, “of mining medical records and real-world data to discover new uses for drugs that are already approved and available is commendable, and the Worldwide team is committed to helping scale these approaches to all drugs and all diseases.”
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By Alan, on May 11th, 2023  (Gerd Altmann, Pixabay. https://pixabay.com/illustrations/physics-quantum-physics-particles-3871213/) 11 May 2023. A business incubator is underway to help start-up enterprises in Denmark working in quantum technologies, particularly with defense-related applications. The Deep Tech Lab – Quantum program in Copenhagen began today, as part of the BioInnovation Institute that offers life science start-up companies initial funding, working space, and business development assistance.
Quantum technology is a derivative of quantum physics, a discipline for describing the behavior of energy and matter at the atomic and more granular sub-atomic levels. When applied to computing, quantum technology offers a much different model than the conventional digital paradigm of data expressed in one or zero (1/0) values. Quantum computing allows for data processing in terms of probabilities, expressed in infinite quantum bits or qubits from 0 to 1, instead of digital bits expressed as 0 or 1, as well as calculations in multiple and simultaneous states.
BioInnovation Institute says it was tasked by the Danish government with creating a start-up incubator for quantum technologies modeled after its biotechnology accelerator programs. For biotech start-ups, the institute supports formation of new enterprises based on research in academic labs, including initial grant funds. BioInnovation Institute also supports newly formed companies with an incubator program and loans that can be converted to equity, as well as follow-on funding and in some cases on-site work space. The institute is funded by a 10-year grant from the Novo Nordisk Foundation, also a funder of research on quantum computing at the Neils Bohr Institute at University of Copenhagen.
Investment of €1 billion in dual-use technologies
Deep Tech Lab – Quantum is expected to be a contribution by Denmark to the Defense Innovation Accelerator for the North Atlantic or DIANA initiative to encourage defense-related deep technology R&D across the NATO alliance. The DIANA project includes support for at least 10 new-business accelerators, with an investor network backed by the NATO Innovation Fund that began in June 2022. The NATO Innovation Fund expects to invest some €1 billion in dual-use technologies such as quantum computing, artificial intelligence, biotechnology, advanced materials, energy, and space.
The NATO Center for Quantum Technologies at the Niels Bohr Institute that began in June 2022 is also a part of the DIANA initiative. “The DIANA quantum center,” says Jan Westenkær Thomsen, head of the Neils Bohr Institute in a BioInnovation Institute statement, “is a unique platform for expanding the Danish eco system and for attracting companies, talent, and investments in Danish high technology, and for further strengthening Danish research in the field of quantum technology.”
BioInnovation Institute expects start-ups taking part in Deep Tech Lab – Quantum to focus on dual-use applications of quantum science, as in advanced radar and communications. Participants in the accelerator, says the institute, will have access to investors and mentors, along with training from experts, office and lab space, and opportunities for equity investments. The initial group of start-ups in the program is expected in autumn 2023.
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By Alan, on May 10th, 2023  (Siwon Lee, Pixabay. https://pixabay.com/photos/chicken-breast-food-ingredients-279848/) 10 May 2023. An international challenge competition seeking sustainable but realistic alternatives to natural chicken and fish protein named its six finalist teams. The Feed the Next Billion challenge, presented by the XPrize competition organization in Los Angeles that promotes development of innovative solutions addressing global problems, has a total purse of $15 million.
The Feed the Next Billion challenge asks participants to propose and demonstrate chicken breast and fish filet alternatives with at least comparable nutrition, taste, and texture of the natural meat product, but also with environmental and animal-friendly processes. XPrize says new food technologies are needed to meet demands of a growing world population, estimated at 9.7 billion in 2050, as well as concerns for a climate in crisis. Growing global incomes also increase demands for meat, which under conventional production methods encourage conversion of forests to farms and pastures, strain water supplies, deplete fish stocks, and promote inhumane treatment of animals.
“Today 9 million people die from hunger every year and 25 percent of humanity isn’t receiving adequate nutrients,” says XPrize board chair Peter Diamandis in an organization statement. “Breakthroughs in food technology will allow us to feed a growing world of 8+ billion people with cheaper, better tasting, and higher quality protein.”
Xprize conducts the Feed the Next Billion challenge, co-sponsored by Aspire, the management group for Advanced Technology Research Council based in Abu Dhabi that funds research and holds technology competitions, and the Tony Robbins Foundation, a charitable organization helping provide millions of meals around the world. Participant teams are asked to demonstrate a process for consistently producing 4 ounces or 115 grams of alternative chicken breast or fish filet with comparable structure, ease of cooking, nutrition, and sensory properties — e.g., aroma and taste — but also a smaller environmental footprint than conventional methods.
Plant-, cell-, or fermentation-based solutions
Since the start of the competition, XPrize received initial proposals in June 2021, with assessment panels winnowing entries from participant teams to 25 international semifinalists, proposing plant-, cell-, or fermentation-based solutions. The semifinalists were asked to develop and demonstrate their products with, according to XPrize, experts from biotechnology, agricultural engineering, and sustainability judging the outputs and processes. Science & Enterprise reported on the start of the competition in Dec. 2020.
The six finalists, dividing $2.5 million in prize money, are:
– CellX, cell-based chicken alternative, in Shanghai, China
– Eternal, chicken alternative from fermentation, in Buenos Aires, Argentina
– The PlantEat, plant-based chicken alternative, in Gyeonggi-do, South Korea
– ProFillet, biomass-fermentation fish alternative, in Halifax, Nova Scotia, Canada
– Revo Foods, plant-based fish alternative in Vienna, Austria
– TFTAK, plant-based fish alternative in Tallinn, Estonia
“Our finalist teams,” notes Feed the Next Billion program director Caroline Kolta, “are demonstrating that we can create structured, versatile alternative meat products with a smaller environmental footprint than their conventional counterparts without sacrificing taste or nutrition.”
The finalist teams are now asked to refine their processes and products, with one more round of demonstrations and awarding of the grand prize scheduled for the first quarter of 2024. A bonus prize is also offered for developing an animal-free growth media at the lowest production cost.
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By Alan, on May 9th, 2023  Dario digital diabetes app (DarioHealth Corp.) 9 May 2023. A study of people with type 2 diabetes shows those using a digital diabetes management system made fewer hospital visits than non-users over a 12-month period. A team from Sanofi U.S. in New York, a division of the global pharmaceutical company, reported the data assessing the DarioHealth Digital Diabetes Solution at the ISPOR 2023 conference now underway in Boston.
Diabetes is chronic disease where islet cells in the pancreas do not produce insulin, or not enough insulin, to convert the sugar glucose in the blood to energy. The continued presence of excess glucose in the blood increases the risk of other long-term health problems such as heart disease, vision loss, skin wounds, and kidney disease. Centers for Disease Control and Prevention says that 90 to 95 percent of the 37.3 million people in the U.S. with diabetes, or 11.3 percent of the total population, have type 2 diabetes where the body does not produce enough insulin or process it well.
DarioHealth Corp. in New York is a developer of electronic medical devices for chronic disease management, including its Dario Diabetes Solution for people with type 2 diabetes. The system uses a pocket-sized and self-contained blood analysis device to read blood glucose levels that sends the data to a companion mobile app. The app, says DarioHealth, also tracks carbs consumed, physical activity, and medication compliance.
In Mar. 2022, DarioHealth and Sanofi announced a multi-year partnership to advance Dario’s digital health systems in the U.S. commercial health care marketplace. One part of that collaboration is to conduct demonstrations of DarioHealth devices and their value to patients, as well as health care providers and payers.
Matched system users and non-users
The ISPOR 2023 paper — ISPOR is a professional society for health economics and outcomes research — reports on hospital visits by people with type 2 diabetes, divided between Dario Diabetes Solution or DDS users and non-users. The paper’s authors from Sanofi U.S. and academia note that people with diabetes are also likely to develop other conditions, and thus their increased use of health care resources is well-documented.
The researchers extracted data from non-identified medical records of 9,779 individuals in the U.S. with type 2 diabetes, of which 2,445 used the DDS system and 7,334 were non-users, and all taking medications to control their condition. The team matched the records of DDS users and non-users by age, sex, race, section of the U.S., and type of health insurance (e.g., commercial, Medicare).
An analysis of the records shows DDS users made 9.3 percent fewer hospital visits for any reason after 12 months than system non-users since the start of the study period, with in-patient hospitalizations 23.5 percent lower among DDS users. In both cases, say the authors, the differences are large enough for statistical reliability. Emergency room visit rates during the 12-month period, however, were similar for both groups.
Omar Manejwala, DarioHealth’s chief medical officer, says in a company statement that the findings demonstrate “Dario’s ability to potentially reduce health care utilization through a holistic, user-centric digital health solution.” Manejwala adds, “These results are important not only to our clients and partners who are looking for solutions to help reduce the cost of care, but also to the market as we push for more accountability in digital health research.”
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By Alan, on May 8th, 2023  (Gerd Altmann, Pixabay) 8 May 2023. Two companies using artificial intelligence to advance biotechnology and design new therapies are merging with a computational-engineering drug discovery enterprise. Recursion in Salt Lake City, Utah is acquiring Cyclica in Toronto, Ontario and Valence Discovery in Montreal, Quebec for a total of $87.5 million in share exchange and option assumption deals.
Recursion discovers new treatments with a combination of data and biological science. The company says its process, called the Recursion Operating System, is based on large-scale data sets in chemistry and biology using advanced analytics and algorithms derived from data science and engineering to conduct massive parallel screenings with its own supercomputer. Those so-called dry lab tools, says Recursion, are combined with cell lines and cultures, to discover new drugs with robotics, computational biology, and automation that can conduct up to 2.2 million experiments each week. The company says this approach makes possible computational routines beyond the scale and complexity of human intelligence, as well as removing implicit biases toward favored solutions.
The company’s pipeline has three rare disease targets and two types of cancer in clinical trials, with four other cancer programs in late discovery or preclinical stages. In May 2018, Science & Enterprise reported on a grant from the Bill and Melinda Gates Foundation to Recursion and a lab at University of California in San Diego for discovering new drugs to treat malaria.
3-D AlphaFold protein sequences
Cyclica is an eight year-old business using artificial intelligence and protein chemistry to discover and design new drugs. The company says its algorithms based on genomics, chemistry, and physics simultaneously test for interactions with target molecules, but also seek off-target effects, to reveal much earlier adverse reactions and chemical activity properties in the body. Cyclica says its models include three-dimensional AlphaFold protein sequences generated by Alphabet’s DeepMind A.I. project. Science & Enterprise last reported on Cyclica in Mar. 2020 when the company formed a joint venture to advance treatments that work like cannabinoids from cannabis plants, for mental health and neuropsychiatric disorders.
Valence Discovery, founded in 2018 and began public operations in 2021, is spun-off from labs and resides at Mila, a research collaboration of universities in Quebec province that studies deep learning in health and environment as well as A.I. ethics. Valence is developing processes for drug discovery and design that make possible the use of algorithms where data sets are small and noisy, improve the functionality of graphic neural networks, and apply generative models to molecular design and medicinal chemistry.
Recursion is acquiring Cyclica for $40 million and Valence Discovery for 47.5 million, payable to those companies’ shareholders in Recursion common stock, and assumption of Cyclica/Valence outstanding options. Valence is expected to join Recursion’s current branch in Montreal. The new combined company, says Recursion, is on track to accelerate the transition to A.I.-first drug discovery in the biotechnology industry.
“The strategic acquisitions of Cyclica and Valence,” says Recursion co-founder and CEO Chris Gibson in a company statement, “add industry-leading capabilities in digital chemistry, as well as machine learning and artificial intelligence, which combined with our large-scale automated wet laboratories and supercomputing capabilities, enables us to deploy what I believe is the most complete, technology-enabled drug discovery solution in the biopharma industry.”
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By Alan, on May 6th, 2023  Click on image for full-size view (CB Insights) 6 May 2023. Science & Enterprise reports occasionally on advances in adapting psychedelic compounds to treat pain, addiction, and depression, with chemicals often considered controlled substances under the law. Our story on Thursday, for example, tells about a clinical trial of 5-MeO-DMT, a mind-altering compound derived from desert toad venom and some South American plants, as a therapy for treatment resistant depression.
The technology intelligence company CB Insights (paid subscription required) says this week however that psychedelic therapies and services are generating little interest among venture investors this year, with only nine deals totaling $21 million. After a high point of $658 million in 59 deals in 2021, the number of investment dollars for psychedelics fell to $237 million in 33 deals last year, with the decline continuing this year, a pattern seen in most business sectors.
One reason for the downturn may be alternative mental health technologies without the legal baggage of psychedelics, such as other psychoactive compounds, mobile apps, and virtual reality. Examples reported this year are in the links below.
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Welcome to Science & Enterprise Science and Enterprise is an online news service begun in 2010, created for researchers and business people interested in taking scientific knowledge to the marketplace.
On the site’s posts published six days a week, you find research discoveries destined to become new products and services, as well as news about finance, intellectual property, regulations, and employment.
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