A number of clinical trials hit primary endpoints in May, despite the COVID-19 pandemic, which still accounted for about 30% of the phase I through phase III news flow during the month.
While clinical trial announcements tracked by BioWorld dropped by 11% from April to May, so did the number of delayed, suspended and terminated trials due to COVID-19. In April, those trials accounted for 45% of the news, while they made up only 21% in May.
Likewise, clinical data of therapeutics or vaccines in development for the disease caused by the SARS-CoV-2 virus were 9% of the overall database entries in May vs. 12% in April.
The 336 entries of clinical data collected in May consisted of phase I data (109), phase II data (136) and phase III data (91). It is a drop of 11% from the 378 clinical data items reported in April.
A total of 102 entries were related to COVID-19 news, with 71 entries due to clinical trials negatively affected by the pandemic, and 31 focused on therapeutic and vaccine development to fight the SARS-CoV-2 virus and its complications.
COVID-19 phase III candidates
Reporting phase III coronavirus therapeutics news were Luxembourg-based Covis Pharma BV and Genentech Inc., a unit of Basel, Switzerland-based Roche Holding AG. Covis started a phase III trial in 400 non-hospitalized COVID-19 patients with its glucocorticoid receptor agonist Alvesco (ciclesonide), an asthma drug, while Genentech launched its 450-patient Remdacta study testing its rheumatoid arthritis drug Actemra plus remdesivir (Gilead Sciences Inc.) in hospitalized patients with COVID-19 pneumonia.
Mumbai, India-based Glenmark Pharmaceuticals Inc. initiated phase III trials in India of its antiviral tablet favipiravir, as well as an open-label Faith phase III study testing the combination of favipiravir and umifenovir, an antiviral for influenza used in China and Russia, in hospitalized patients with moderate COVID-19 infection. And Burlingame, Calif.-based Humanigen Inc. dosed the first participant in a pivotal study of lenzilumab, a GM-CSF ligand inhibitor, to prevent or minimize cytokine storm associated with COVID-19 infection.
The majority of clinical news concerning COVID-19 candidates during May was at the phase I and phase II stages. As for vaccines, Cambridge, Mass.-based Moderna Inc. reported it had dosed the first participants in a phase II trial of mRNA-1273, while Mainz, Germany-based Biontech SE, along with New York-based Pfizer Inc., had dosed those entering its phase I/II trial of BNT-162, another mRNA vaccine. Notably, Moderna priced a record-breaking $1.34 billion follow-on offering in May to help fund mRNA-1273.
Clinical wins and losses
Aside from COVID-19 efforts, a number of biopharma companies reported positive phase III results in other indications in May, including New York-based TG Therapeutics Inc. Top-line data of umbralisib, a dual inhibitor of P13K-delta and CK1-epsilon, in addition to CD20 antibody ublituximab, showed the combination met the primary endpoint with a statistically significant improvement in progression-free survival when compared to obinutuzumab plus chlorambucil in relapsed/refractory chronic lymphocytic leukemia patients.
Others hitting primary endpoints in phase III trials in May are Cambridge, Mass.-based Akebia Therapeutics Inc.’s vadadustat for anemia due to chronic kidney disease, Brisbane, Calif.-based Myokardia Inc.’s mavacamten for obstructive hypertophic cardiomyopathy, and Breda, the Netherlands-based Argenx NV’s efgartigimod for myasthenia gravis. Argenx plans to submit a BLA by the end of 2020. Two prostate cancer candidates also reached statistical significance: New Brunswick, N.J.-based Johnson & Johnson’s Erleada; and New York-based Pfizer Inc. and Tokyo-based Astellas Pharma Inc.’s Xtandi.
Disappointing phase III data in May were reported by Milan-based Newron Pharmaceuticals SpA, Lille, France-based Genfit SA and Waltham, Mass.-based Minerva Neurosciences Inc., all of which failed to hit primary endpoints for sarizotan for Rett syndrome, elafibranor for nonalcoholic steatohepatitis and roluperidone for schizophrenia, respectively. Newron terminated its sarizotan program.
Clinical data collected in 2020, January through May, can be found at the following links:
Biopharma financings data for 2020 through June 11 can be found here: