Feb. 12 COVID Quick Takes: Actemra reduces mortality in RECOVERY trial; plus updates from AZ, CanSino, Celltrion, NeuroRx, CureVac and Moderna
While previous trials of Actemra tocilizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) failed to demonstrate a survival benefit for COVID-19 patients, the U.K. RECOVERY trial found a 4% absolute reduction in mortality rate (rate ratio = 0.86, p=0.007) in hospitalized patients with severe COVID-19. Previous studies may have been underpowered, as the RECOVERY trial tested the IL-6 inhibitor in over 10 times as many patients as the studies before it.
AZ tackling new COVID-19 variants
Although AstraZeneca plc (LSE:AZN; NASDAQ:AZN) reported a small decrease in efficacy of its COVID-19 vaccine C19VAZ (AZD1222) against symptomatic disease caused by the B.1.1.7 variant first identified in the U.K., the pharma and the University of Oxford are planning ahead to adapt the vaccine to new disease strains. The partners aim to reduce the time needed to reach production at scale to between six and nine months by utilizing existing clinical data and optimizing the supply chain.
Mexico authorizes CanSino vaccine
CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) announced adenoviral vector vaccine Convidecia (Ad5-NCoV) gained approval for emergency use, based on interim Phase III data, from the Federal Commission for Protection against Sanitary Risks of Mexico. On Monday, Faisal Sultan, special assistant to Pakistani PM Imran Khan on health, tweeted that the adenoviral vector vaccine was 65.7% effective at preventing symptomatic cases, and 92% effective at preventing severe disease in a Phase III study that included individuals from Pakistan, Mexico, Russia, Argentina and Chile.
Celltrion mAb authorized in South Korea
The Korean Ministry of Food and Drug Safety granted conditional marketing authorization to regdanvimab (CT-P59) from Celltrion Inc. (KOSDAQ:068270) to treat COVID-19. The neutralizing mAb is indicated for emergency use in patients with moderate COVID-19 and at-risk individuals with mild disease. The authorization was based on Part 1 of a Phase II/III trial showing regdanvimab reduced hospitalization and oxygenation through Day 28. It also lowered risk of developing severe COVID-19 by 54% in patients with mild to moderate symptoms, and by 68% in patients ages ≥50 with moderate disease. The mAb shortened time to clinical recovery by 3.4-6.4 days.
EMA starts rolling review of CureVac’s COVID-19 vaccine
EMA started a rolling review of CVnCoV from CureVac N.V. (NASDAQ:CVAC). The mRNA COVID-19 vaccine encoding the spike protein is currently in a pivotal Phase IIb/III trial.
U.S. government secures additional doses of Moderna, BioNTech vaccines
The U.S. government purchased an additional 100 million doses of COVID-19 vaccines from Moderna Inc. (NASDAQ:MRNA) and partners Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), bringing the total doses purchased to 600 million. Each company is delivering 300 million doses through July.
NeuroRx to discuss EUA based on shortened hospitalization
NeuroRx Inc. said Zyesami aviptadil shortened hospitalization time in a Phase IIb/III trial to treat patients with respiratory failure due to critical COVID-19. It plans to discuss emergency use authorization with FDA and other regulators based on preliminary data from the study, which was run with Relief Therapeutics Holding AG (SIX:RLF). NeuroRx also disclosed that the synthetic peptide-based vasoactive intestinal polypeptide (VIP) did not improve 28-day survival, a secondary endpoint, and that summary data didn’t show an overall difference on the primary endpoint of recovery from respiratory failure. Investigators are confirming the timing of each recovery case.