The decision comes after the Phase II MOONSONG trial on the oral antiviral pill AT-527 failed to meet the primary endpoint in October.
Roche and Atea Pharmaceuticals are terminating their partnership to develop and commercialize a COVID-19 antiviral effective February 10, 2022.
The decision comes after the Phase II MOONSONG trial on the oral antiviral pill AT-527 failed to meet the primary endpoint in October, leading to Atea’s shares slumping by 68.6%. AT-527 was being evaluated as an oral direct-acting antiviral treatment for patients with mild to moderate cases of SARS-CoV-2 infection.
In October, Atea said that although the drug did not meet the primary endpoint of reduction from baseline in the SARS-CoV-2 viral load in low-risk patients, it showed promise among high-risk patients with underlying health conditions. Plans to move forward to a Phase III trial by the second half of 2022 were discussed, but now it seems that only Atea will be going at it alone.
“We have the financial resources and the talent to independently drive forward the Phase III MORNINGSKY clinical trial program, and we continue to expect data from this trial during the second half of 2022. We are energized by the opportunity to move forward with full ownership, providing us with autonomy to efficiently bring AT-527 to market,” said Jean-Pierre Sommadossi, Ph.D., the chief executive officer and founder of Atea, said in a statement.
As of September 30, 2021, the company said it has $839.7 million in cash and cash equivalents, which is sufficient to carry its efforts through 2023. Atea and Roche announced their partnership for AT-527 in October 2020, with the goal to produce an oral pill that would help treat patients early and reduce the progression of the infection. If it had succeeded, that plan was for Atea to take care of U.S. distribution, while Roche would be responsible for the manufacturing and distributing elsewhere worldwide.
“We are continuing to expedite efforts to submit the recently announced Phase III MORNINGSKY amendment to global health authorities. We have an established development team at Atea with extensive global clinical trial experience, as well as outside resources we continue to leverage. We remain committed to developing and delivering AT-527 as an oral antiviral that will address treatment needs for patients as COVID-19 continues to evolve,” added Janet Hammond, M.D., Ph.D., the chief development officer of Atea Pharmaceuticals, in the same press release.
Roche has yet to make an official statement on the matter. The company currently has its sights on another drug called Ronapreve (casirivimab and imdevimab), which was recently granted marketing authorization from the European Commission to treat COVID-19 in adults and adolescents 12 years and up. Also known as REGEN-COV in the U.S., the drug has been studied across several Phase III trials in both low-risk and hospitalized patients with positive results. Roche is developing this drug with Regeneron.
