Covid-19 roundup: Merck, Ridgeback drop new analyses for molnupiravir; Veru submits EUA for antiviral treatment
As Merck and Ridgeback look to make their Covid antiviral more competitive to Pfizer’s Paxlovid, the companies published additional data from their Phase III trial evaluating molnupiravir, otherwise known as Lageviro.
The trial investigated non-hospitalized adults with mild to moderate Covid-19 who were at high risk for progressing to severe disease. Results showed the exploratory endpoints indicated that a lower proportion of Lageviro-treated participants had an acute care visit or a Covid-19-related acute care visit versus placebo-treated participants.
Data also showed that 7.2% of participants who received the antiviral reported an acute care visit through day 29, versus 10.6% of placebo participants, with a relative risk reduction of 32.1%.
Merck also said fewer people treated in the MITT population required respiratory interventions versus placebo-treated participants, with a RRR of 34.3% for all respiratory interventions.
“The analyses add to our understanding of the clinical profile of Lageviro and help to reinforce the importance of Lageviro as part of the response to the COVID-19 pandemic,” said Dean Li, president of Merck Research Laboratories.
The antiviral is also being evaluated for post-exposure prophylaxis in another Phase III study, looking at preventing the spread of Covid-19 within households.
According to Merck, it has 8 million courses of the drug for governments in more than 30 markets across the globe.
However, Merck has a lot of catching up to do. In May, it was reported that Lageviro has struggled to make its way out of the inventory closet, according to numbers posted by HHS. Only about 20,000 courses of the Merck pill were used in the past week, and only about 13% of the total US inventory has been used to date.
This is not the only stumbling block that the antiviral has gone up against. In February, the FDA revised the EUA for molnupiravir, explaining that it should only be used as a last line of defense if other treatments are available. The EUA, initially issued on Dec. 23, 2021, said the pill should be for the treatment of mild-to-moderate Covid-19 in adults with positive results of SARS-CoV-2 viral testing, and who are at high risk for progressing to hospitalization or death — but only when alternative treatment options authorized by FDA are not accessible or clinically appropriate.
Now, Merck is also competing with Paxlovid at a time when Pfizer has dominated the market and is continuing to invest heavily in its manufacturing capacity, announcing plans to increase production at its plant in Kalamazoo, MI on Monday.
Veru submits Covid antiviral to the FDA for a EUA
After its Phase III was shut down early in April due to “overwhelming efficacy,” Veru’s Covid antiviral has a date with the FDA.
The company has submitted a EUA for its sabizabulin oral 9 mg treatment of moderate-to-severe hospitalized Covid-19 patients at high risk for developing acute respiratory distress syndrome, or ARDS.
Veru is basing this submission on its Phase III clinical trial evaluating sabizabulin in approximately 204 hospitalized Covid-19 patients with moderate-to-severe cases.
The primary endpoint Veru used was the proportion of deaths by Day 60. The trial showed that the drug resulted in a 55.2% relative reduction in deaths before the IDMC ended it due to overwhelming efficacy.
“Covid-19 new cases and hospitalizations are on the rise again with a summer and fall-winter peaks expected. Unfortunately, the death rate in hospitalized patients with moderate to severe Covid-19 who are at risk for ARDS remains and will continue to be unacceptably high with the current standard of care,” said Veru CEO Mitchell Steiner.
The news has appeared to pique the interest of Veru’s investors as the company has seen its stock $VERU jump 17% in early Tuesday trading and by 94% in the last month.