Covid-19 roundup: Pfizer, Merck start late-stage trials for Covid-19 pills; Merck begins PhIII study on post-exposure treatment
Pharma giants Pfizer and Merck announced today that they are moving forward with Phase II and III clinical trials for antiviral treatments against Covid-19 — a significant milestone in the more than year-long battle against the pandemic.
The drugs represent two of the leading efforts to treat Covid-19 with a pill, a potential breakthrough given that all doctors and hospitals have available today need to be either infused or injected – and they have been in short supply. Outside of the vaccines, few products have been approved to fight the virus and a pill could present the best weapon to treat newly infected or exposed patients before they wind up in a hospital.
Pfizer announced today that the first participant has been dosed in a pivotal Phase II/III clinical trial to evaluate the safety and efficacy of PF-07321332, an experimental oral protease inhibitor designed to combat the coronavirus.
The patients in that study are non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection and are not at increased risk of progressing to severe illness.
The randomized and double-blind trial will enroll approximately 1,140 participants, who will receive PF- 07321332 with HIV antiretroviral ritonavir or placebo orally every 12 hours for five days.
Co-administration with a low dose of ritonavir is expected to help slow the breakdown of PF-07321332, helping it remain in the body for longer periods of time at higher concentrations, according to Pfizer.
If proven successful, PF-07321332 in conjunction with ritonavir could be yet another avenue to combat the coronavirus without requiring hospitalization. — Paul Schloesser
Merck & partner announce Phase III study on post-exposure Covid treatment
Merck and partner Ridgeback Biotherapeutics announced today the start of Phase III clinical trial MOVe-AHEAD, to evaluate their experimental oral antiviral molnupiravir as a Covid-19 preventative. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms.
“As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” said Nick Kartsonis, SVP of vaccines and infectious diseases for Merck Research Laboratories. “If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”
The safety and efficacy of molnupiravir is also currently being evaluated in Part 2 of another trial known as MOVe-OUT, a global Phase III, randomized, placebo-controlled, double-blind, multi-site study. That study is studying molnupiravir in non-hospitalized adult patients with lab-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. Data from that study is expected by the end of the year. — Paul Schloesser
Mesoblast takes another hit as FDA demands additional trial ahead of any EUA review
Shares of Mesoblast $MESO tumbled 12% on Tuesday after the small Australian biotech reported that the FDA is demanding another trial before the agency will consider an emergency authorization for their experimental drug remestemcel-L for Covid patients suffering from acute respiratory distress syndrome.
A slew of small biotechs have been beavering away, attempting to capture the FDA’s attention with enough data to gain a coveted EUA — something that has been the preserve of major players or smaller companies tied to the giants.
In Mesoblast’s case, execs pitched data from a failed trial after Novartis stepped up with a $1.2 billion deal on their drug — with $25 million coming in an upfront payment. That deal also covered the drug’s use for Covid patients.
Soon after the signing with Novartis, Mesoblast was forced to concede that their anti-inflammatory had failed their Covid trial and that independent monitors wanted it cut short due to futility. Then, months later, they teased out positive data from a subset of patients and hustled that to the FDA.
It wasn’t enough.
Mesoblast has experienced a series of setbacks over the course of the past 12 months. The FDA rejected their application on remestemcel-L for acute graft-vs-host disease last fall. A few months later the drug failed a late-stage trial for heart failure. And it’s also had to contend with a red flag from their auditors on their ability to continue as a going concern. — John Carroll