Biopharma Update on the Novel Coronavirus: April 13

CV Update_April 13

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FDA Actions

Authorization to Decontaminate Millions of N95 Respirators: The FDA issued a EUA that has the potential to decontaminate approximately 4 million N95 or N-95 equivalent respirators per day. The decontaminated masks can then be reused by health care workers.

The FDA has issued a EUA to STERIS Corporation to use the STERIS N95 Decontamination Cycle.

EUA for Blood Purification System: The FDA issued an EUA to Terumo BCT Inc. and Marker Therapeutics AG.

Letter to Stakeholders: The FDA issued a letter that advises people not to use ivermectin, which is intended for animals as a treatment for COVID-19 in humans.

Pharmacy Compounds: The FDA issued guidance for a temporary policy for non-standard PPE practices for sterile compounding by pharmacy compounders who are not registered as outsourcing facilities. This is only for the duration of the COVID-19 pandemic.

Warning Letter: The FDA and the FTC issued a warning letter to Earthly Wellness DBA Modern Alternative Mama LLC. for selling fraudulent products as a way to treat or prevent COVID-19.

Diagnostics Update: The FDA has worked with more than 300 test developers who plan to submit EUA requests to detect COVID-19. Also, 33 EUAs have been issued. The FDA has been notified that more than 170 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

 

Diagnostics

Currently, the tests to diagnose COVID-19 require a swab from deep in the nasal passages or the back of the throat. The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva. The test method was developed by RUCDR with Spectrum Solutions and Accurate Diagnostic Labs (ADL).

Stanford Medicine researchers have joined the list of organizations that have developed an antibody test, which was launched on April 6 at Stanford Health Care. It is different from an externally developed test Stanford utilized for a prevalence study during a community screening event.

 

Testing Therapies, Antivirals and Vaccines

Gilead Sciences is running at least five clinical trials for its experimental antiviral drug remdesivir against COVID-19. Readouts for at least one or two of them will occur this month. Meanwhile, more than 1,800 patients have been treated using the drug on an individual compassionate use basis so far. And they published data in the New England Journal of Medicine on 53 of those patients suggesting promising results.

CytoDyn reported more than 25 patients have received leronlimab under EINDs from the FDA, and the rate of response in mild-to-moderate patients has been very promising with the first five patients treated being removed from oxygen. So far, as of April 10, 12 patients had been treated in the Phase II trial for mild-to-moderate COVID-19, but results are not yet available. The first site was cleared to enroll patients in the Phase IIb/III beginning April 13.

Bausch Health initiated a clinical trial program in Canada to study Virazole (Ribavirin for Inhalation Solution, USP) in combination with standard of care for adults with respiratory distress from COVID-19. Ribavirin is a synthetic nucleoside that stops viral replication. The trial has been approved by Health Canada and is expected to launch within the next few weeks.

A GlobalData report indicates that so far, 21 COVID-19 clinical trials have been completed, with most sponsored by Chinese hospitals and in the Wuhan province. Few outstanding possible drug candidates have emerged. Only five trials successfully achieved the endpoint of efficacy and safety.

Vancouver-based Algernon Pharmaceuticals received positive feedback from the FDA regarding the company’s plans to conduct a phase 2 COVID-19 clinical trial using its repurposed drug NP-120 (Ifenprodil). Algernon intends to launch a Phase II trial with Ifenprodil, as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. Ifenprodil is an N-methyl-D-aspartate receptor antagonist specifically targeting the NMDA-type subunit 2B. 

Ennaid Therapeutics is advancing the development of ENU200, as a therapeutic to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 viral infections. In-silico modeling revealed that ENU200 delivers specific antiviral activity against two SARS-CoV-2 proteins, S glycoprotein and Mpro.

 

Company Actions

E-commerce giant Amazon is redirecting some assets to build COVID-19 testing facilities for its employees to ensure business and the economy can continue during the pandemic. 

 

Other Industry News

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