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Small Biz Grant Funds Biofilm Infection Peptides

Pseudomonas aeruginosa

Pseudomonas aeruginosa colony (Harvard Medical School, NIH)

20 Dec. 2021. A start-up company is receiving a National Institutes of Health grant to develop peptides for preventing bacterial films causing middle ear infections. Clarametyx Biosciences Inc. in Columbus, Ohio is receiving the three-year $3.15 million award from National Institute on Deafness and Other Communication Disorders, or NIDCD, part of NIH.

Clarametyx Bio says the award supports development of its synthetic peptides code-named CMTX-301 to prevent biofilms responsible for persistent infections, beginning with middle ear infections, also known as otitis media. The middle ear, located behind the eardrum, contains small vibrating bones, but that space is also prone to infections, particularly among children. These infections can be painful and result in complications, including long-term hearing problems. Most middle ear infections today are treated with antibiotics.

The company’s technology targets biofilms, communities of bacteria that connect and expand through a matrix of organic matter. These microbe colonies also stick tightly to surfaces, including human tissue and implanted devices, making them difficult to treat because of their persistence and ability to resist conventional antibiotics. Clarametyx Bio develops synthetic human antibodies and peptides, short chains of amino acids, that produce an immune response attacking or preventing bacterial biofilm formation, as well as reducing inflammation caused by biofilms.

Clarametyx Bio is a two year-old biotechnology company spun-off from research labs at Nationwide Children’s Hospital in Columbus. The company licenses research by Lauren Bakaletz, director of the Center for Microbial Pathogenesis at Nationwide Children’s, who studies microbial infections in the respiratory tract and middle ear. The company’s technology also adapts research by bacteriologist Steven Goodman, who with Bakaletz, studies biofilm formation and mitigation measures at Nationwide Children’s. Bakaletz and Goodman are scientific advisors to Clarametyx Bio.

Reduce reliance on conventional antibiotics

The NIDCD grant funds development of CMTX-301 as a vaccine to prevent infections from a broad range of pathogens, beginning with those in the middle ear. CMTX-301 is designed as peptides to invoke an immune reaction that attack bacteria that form into biofilms. Clarametyx Bio says NIDCD’s funds will support preclinical work to identify the most promising vaccine candidates, and establish proof of concept, leading to an investigational new drug or IND application with the Food and Drug Administration. An IND application is, in effect, a request to begin clinical trials.

The company says this new approach to fighting biofilms can help reduce reliance on conventional antibiotics and provide more tools against antibiotic resistance. “There is a defined need for a more effective broad-spectrum vaccine that prevents otitis media, a highly common infection in children,” says Clarametyx Bio CEO David Richards in a company statement. “NIH’s grant for this technology reflects this need and validates this novel opportunity to address multi-pathogen bacterial infections by targeting the biofilm.”

Richards adds, “We believe this technology could dramatically improve the treatment of complex and recurrent bacterial infections in multiple high-need indications, not only improving clinical outcomes but also reducing the reliance on multiple courses of antibiotics, thereby reducing the threat of resistance.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This grant appears to combine both phases into a single project.

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