While the volume of clinical data in July dipped below previous pandemic months, the amount of news focused on therapeutics or vaccines for COVID-19 is climbing, representing about 16% of BioWorld’s database entries during the month.
In comparing the last four months for overall Phase I, II and III clinical data, July is the slowest month with only 297 items of clinical data collected, consisting of phase I data (119), phase II data (92) and phase III data (86). That is nearly 22% fewer entries than the 380 in June, and still below the 336 in May and 378 in April.
July’s clinical data consists of four trials reporting delays or disruptions due to the COVID-19 pandemic. Such delays have dropped off dramatically in the last two months. There were 17 reported in June, compared with 60 in May, 248 in April and 97 in March, indicating the biopharma industry has moved toward a business-as-usual approach, despite escalating pandemic concerns and warnings of a second societal lockdown. In July, a total of five companies reported that their trials have resumed following COVID-19-related delays announced in previous months.
While the virus was responsible for 57% of the phase I-III data in April and 30% in May, most of the news during those months encompassed clinical trial delays, with a much smaller percentage covering data readouts or launched trials of pandemic therapies. The tables turned in June and July, however, when COVID-19 news was 13% and 19% of the data, respectively. Looking only at data of vaccines and therapeutics for COVID-19, there were a total of 48 entries in July (16%) vs. 37 in June (10%), 31 in May (12%) and 44 in April (9%).
China National Pharmaceutical Group Co. Ltd. (Sinopharm), of Beijing, launched in July a phase III trial of a COVID-19 inactivated vaccine in Abu Dhabi. Cambridge, Mass.-based Moderna Inc. also started its phase III trial of mRNA-1273 with 30,000 participants. Two COVID-19 therapeutics entering phase III trials in July included Warren, N.J.-based Bellerophon Therapeutics Inc.’s inhaled nitric oxide therapy Inopulse and Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.’s double-antibody cocktail REGN-CoV2.
Positive phase III data for COVID-19 therapeutic candidates was reported with Foster City, Calif.-based Gilead Sciences Inc.’s remdesivir, which was associated with improvement in clinical recovery and a 62% reduction in the risk of mortality vs. standard of care, according to a comparative analysis of the Simple-Severe trial. Mumbai, India-based Glenmark Pharmaceuticals Ltd.’s favipiravir also demonstrated statistically significant top-line results, showing it can treat cases of mild to moderate COVID-19 in four days.
Reporting negative phase III data in July for COVID-19 therapeutics was Paris-based Sanofi SA and partner Regeneron when Kevzara (sarilumab), a monoclonal antibody targeting IL-6, failed to meet its primary composite endpoint. The U.S. trial was thereby stopped. Genentech Inc., a unit of Basel, Switzerland-based Roche AG, also announced that Actemra (tocilizumab), its IL-6 receptor antagonist, missed both the primary endpoint of improved clinical status in those with COVID-19 associated pneumonia and the key secondary endpoint of reduced mortality.
Clinical data collected in 2020, January through July, can be found at the following links:
Biopharma financings data for 2020 through Aug. 13 can be found here: