Enanta Pharmaceuticals doesn’t think it’s too late to get into the COVID-19 treatment landscape, especially as the omicron variant sends cases skyrocketing in the U.S. to all-time highs. In addition, the biotech sees the need for meds extending into the endemic stage.
While Pfizer and Merck have already put their COVID-19 treatments through the clinic and notched emergency use authorization nods from the FDA, Enanta is just about to enter the clinic.
The biotech expects to begin clinical trials next month with a protease inhibitor that it says is “very, very potent” against variants of concern including omicron in preclinical models, said Jay Luly, Ph.D., president and CEO, during a presentation at the annual J.P. Morgan Healthcare Conference on Tuesday afternoon.
“There’s gonna be a global short supply of antiviral therapy, even under emergency use authorization, for a significant period of time,” Luly said. There’s an “enormous unmet need” in this area, the CEO said, given many pockets of the world aren’t vaccinated and considering omicron might not be the last variant of concern.
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Luly attempted to justify the long wait to enter the clinic by saying Enanta was “patiently designing” its investigational med, EDP-235, because it sees the need for safe and efficacious drugs beyond the immediate horizon and into the endemic part of COVID-19.
The biotech, which has recently culled oral hepatitis B and nonalcoholic steatohepatitis programs, will test EDP-235 against SARS-CoV-2, the virus behind COVID-19, and the study will initially enroll healthy volunteers. Participants will receive 100 mg to 500 mg once a day, Luly said. Of note, Enanta does not anticipate needing a ritonavir booster, the CEO said, compared to Pfizer’s recently approved Paxlovid, which includes the HIV drug. The Big Pharma’s greenlighted regimen includes 20 Paxlovid pills and 10 ritonavir pills taken over five days.
Attempting to get a COVID-19 treatment across the finish line, though, is no easy task. Many biopharmas have tried and failed since the onset of the pandemic. Atea Pharmaceuticals, for one, is still moving ahead without ex-partner Roche on a failed COVID-19 antiviral. Mesoblast is also trying to advance a phase 3 of its failed cell therapy after Novartis cut ties with the company last month.
Other biotechs to strike out on COVID-19 treatments include: RedHill Biopharma, CytoDyn and Laurent Pharmaceuticals.
Elsewhere in Enanta’s pipeline, the biotech is testing EDP-938, an N-protein inhibitor, in three ongoing phase 2 trials in respiratory syncytial virus.