Science & Enterprise subscription

Follow us on Twitter

  • Don't let the perfect be the enemy of the good ... https://t.co/nHtOdudliO
    about 16 hours ago
  • Among the tech giants, Apple is the most aggressive in acquiring start-ups developing A.I. applications over the pa… https://t.co/RjpknHBKAR
    about 23 hours ago
  • New post on Science and Enterprise: Infographic – Apple Leads in A.I. Acquistions https://t.co/WTof485yka #Science #Business
    about 23 hours ago
  • HBCUs still hand out more bachelor's degrees in STEM fields to Blacks than traditionally white institutions, but no… https://t.co/xW2ICnR09b
    about 2 days ago
  • Special to Science and Enterprise ... HBCUs Still Putting Blacks in STEM by @crparks3 https://t.co/Osm8eeUaM2… https://t.co/SOiQkh7SO1
    about 2 days ago

Please share Science & Enterprise

Drug Added to Covid-19 Lung Disease Trial

lung illustration

(Kai Stachowiak, Pixabay)

28 May 2020. A clinical trial evaluating numerous therapies for a serious lung complication of Covid-19 infections is adding a drug to treat glaucoma to the study. The I-SPY Covid trial, an adaptive clinical study assessing 10 to 20 drugs for treating acute respiratory distress syndrome, or ARDS, is adding the drug razuprotafib, made by Aerpio Pharmaceuticals, to its test therapy list.

ARDS is a life-threatening complication where fluid leaks into the lungs. ARDS is often triggered by injury to the lungs, and in the case of Covid-19 infections, from inflammation reacting to the SARS-CoV-2 virus responsible for the infections. The fluid build-up makes breathing difficult and adequate oxygen does not get to the body, requiring supplemental oxygen or mechanical ventilation for weeks at a time in some cases.

Aerpio Pharmaceuticals in Cincinnati, Ohio is developing razuprotafib as a treatment for the eye disease open angle glaucoma and vascular complications of diabetes, including kidney damage called diabetic nephropathy. Razuprotafib blocks vascular endothelial protein tyrosine phosphatase, or VE-PTP, that depresses production of Tie2 receptor proteins. Tie2 proteins are receptors on the surface of cells that bind to angiopoietins, which are protein growth factors needed to form blood vessels.

Thus, razuprotafib activates Tie2 receptor proteins, allowing for stable blood vessel formation in affected tissue in the eyes and kidneys, which the company is testing in mid-stage clinical trials. Aerpio says it has preclinical evidence showing the drug’s beneficial effects extend to a number of disease states including ARDS resulting from Covid-19 infections.

The company also notes that data from other studies, including preclinical tests and observational studies, associate Tie2 with defense against blood cell damage from ARDS. The I-Spy Covid study team is looking primarily for razuprotafib’s ability to stabilize blood vessels in lungs of ARDS patients, prevent progression of the disease, decrease the use of ventilators, and reduce mortality.

Joseph Gardner, president and founder of Aerpio, says in a company statement that adding razuprotafib to the trial, “will allow us to evaluate the drug in severely ill Covid-19 patients and quickly assess both preliminary safety and efficacy and guide future development plans.  If successfully developed, approved, and commercialized, razuprotafib has the potential to help save lives and render the disease less life threatening in the patients most at risk.”

The I-SPY Covid trial uses an adaptive design with algorithms that make it possible to quickly alter factors such as treatment regimens or sample sizes based on interim results. Adaptive trials often are governed by a master protocol, where a single basic study structure allows for testing a series of treatments, making it possible to accommodate new treatments, samples, or changes in direction without starting over from scratch.

I-SPY stands for Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis, an adaptive clinical trial underway testing a number of proposed breast cancer treatments. The I-SPY trials are sponsored by QuantumLeap Healthcare Collaborative, a group of organizations, academic labs, and drug companies in San Francisco. As reported by Science & Enterprise in September 2018, the I-SPY2 trial by that time helped advance seven new breast cancer drugs to FDA for review.

More from Science & Enterprise:

*     *     *

Please share Science & Enterprise ...

Comments are closed.