Atea Pharmaceuticals has already laid off a quarter of its workforce so far this year as the biotech prepares to launch a phase 3 trial of its hepatitis C cocktail.
The treatment—a combination of the nucleotide analog polymerase inhibitor bemnifosbuvir and the NS5A inhibitor ruzasvir—hit the primary endpoints of safety and sustained virologic response in a phase 2 trial in December. Now, Atea is planning to launch two phase 3 trials, with enrolment slated for April.
Those trials, which will be conducted in North America and outside North America, respectively, will see the combo treatment compared to a regimen of sofosbuvir and velpatasvir, which is approved to treat hepatitis C virus (HCV) under the brand name Epclusa.
“I am pleased to share that we recently had a successful end-of-phase 2 meeting with the FDA, and we expect enrollment to begin next month in our global HCV phase 3 program evaluating the regimen of bemnifosbuvir and ruzasvir,” Atea’s CEO Jean-Pierre Sommadossi, Ph.D., said in the release.
“Results to-date demonstrate the potency of our potential best-in-class regimen with a short 8-week treatment duration, low risk of drug-drug interactions and convenience with no food effect,” Sommadossi added.
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“We believe our regimen, if approved, has the potential to play a major role in the eradication of HCV in the U.S. and to disrupt and expand the global HCV market,” the CEO added.
Eyeing a global HCV market of $3 billion a year, Atea said in its fourth-quarter earnings that it has enlisted investment bank Evercore to help the biotech “explor[e] strategic partnerships related to its phase 3 program for the treatment of HCV.”
To this end, the company has already sought out ways to “enhance efficiency in the management of infrastructure expenditures,” which led Atea to reduce its workforce by around 25% since the start of the year. This should bring in savings of $15 million through 2027, it explained in the March 6 post-market release.
Atea entered the new year with $454.7 million in the bank, which it believes should pave a cash runway into 2028.
William Blair analysts said they are “bullish … on the disruptive potential for bemnifosbuvir and ruzasvir,” pointing to the historical trend for successful phase 2 HCV trials to translate into phase 3 wins.
By combining an 8-week treatment duration with the low potential for drug-drug interactions, Atea is “essentially merging the best clinical characteristics” of Epclusa and AbbVie’s HCV combo Mavyret, the analysts said.
This comes after the biotech last year was forced to give up work in COVID after its antiviral failed several key tests. Back in 2023 Atea also sidelined its dengue fever drug after deciding the phase 2 costs wouldn’t be worth it.