Biopharma Update on the Novel Coronavirus: July 13
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Domestic Inspections: The FDA issued a statement to resume domestic inspections with a new risk-assessment system. The COVID-19 Advisory Rating system uses data that is real-time to help FDA investigators determine when and where it is safest to conduct prioritized domestic inspections. The FDA expects to resume on-site inspections during the week of July 20.
New EUAs Issued: The FDA issued new EUAs or diagnostic tests as follows.
- The University of California-San Francisco’s Health Clinical Laboratories-UCSF Clinical Labs at China Basin (SARS-CoV-2 RNA DETECTR Assay)
- BioSewoom, Inc. (Real-Q 2019-nCoV Detection Kit)
Diagnostics Update: To-date the FDA has authorized 173 individual EUAs, which include 144 molecular tests, 27 antibody tests and 2 antigen tests.
Testing Therapies, Antivirals and Vaccines
The U.S. Food and Drug Administration granted Fast Track designation to the COVID-19 vaccine candidate under development by Pfizer and Germany’s BioNTech. The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
Equillium announced that its partner, Biocon, reported data from a clinical trial showing that itolizumab significantly decreased mortality in hospitalized COVID-19 patients. The clinical trial was conducted in India by Biocon. Equillium is headquartered in La Jolla, California. Biocon is based in Bengaluru, India.
ExeGi Pharma announced the results of a 70-patient trial of high-dose, eight-strain bacteriotherapy in COVID-19. The trial was conducted in the hospital setting in Rome. Patients received the drug as well as standard of care of hydroxychloroquine, antibiotics, and tocilizumab and were compared to the standard of care alone. The biologic appeared to mitigate COVID-19 severity by modulating the gut-lung axis.
Innovation Pharma provided some details on the planned clinical trial testing of Brilacidin for the treatment of COVID-19. The company has indicated plans to advance Brilacidin into human trials during the fourth quarter of 2020.
Bellerophon Therapeutics dosed its first patient in a Phase III study of its INOpulse inhaled nitric oxide therapy for COVID-19 treatment. The study will evaluate the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen.
Avacta Group entered into a collaboration with Integumen plc to evaluate recently generated Affimer reagents that bind the SARS-COV-2 spike protein for the detection of the coronavirus in wastewater, to provide a real-time alert system to warn of localized COVID-19 outbreaks. Over 60% of COVID-19 positive patients had gastrointestinal symptoms, such as diarrhea, nausea and vomiting, and the SARS-COV-2 virus was found in their fecal samples. Sampling wastewater from households may provide an early warning system for localized outbreaks in communities, the company believes.
Junshi Biosciences completed enrollment in a Phase I trial of SARS-CoV-2 neutralizing monoclonal antibody injection. This marks the first COVID-19 neutralizing antibody entering clinical trials in China. The study will assess an intravenous treatment JS016 in patients. Junshi Biosciences plans to initiate Phase Ib trial in non-severe COVID-19 patients and Phase II/III trials in severe and critical patients soon. Simultaneously, the company will investigate the prophylactic potential of JS016 in high-risk populations.
Altimmune, Inc. and the University of Alabama at Birmingham announced positive results from the preclinical studies of its intranasal COVID-19 vaccine candidate, AdCOVID. The data showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The company plans to begin manufacturing of AdCOVID and advance the vaccine candidate to a Phase I safety and immunogenicity study in Q4 of this year.