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Recently, Roche and Aea Pharmaceuticals announced that their global phase II trial of the new coronavirus oral drug AT-527, MOONSONG, has not reached the primary endpoint. On the day of the announcement, Atea shares plunged 66% and Roche edged down 1.64%.
AT-527 was developed by Atea as an RNA polymerase inhibitor that specifically inhibits viral RNA-dependent RNA polymerase, thereby inhibiting viral replication and transcription, so it has a unique dual inhibition mechanism for the new coronavirus, and its in vitro and in vivo antiviral activity has been confirmed in several single-stranded RNA viruses (including human flavivirus and coronavirus). Last October, Roche acquired development and commercial rights to the drug outside the U.S. for a $350 million down payment.
The Phase II clinical trial of AT-5272 is primarily used to treat patients with moderate COVID-19 who require hospitalization and patients with mild to moderate COVID-19 who are not hospitalized, with the primary clinical endpoint being viral RNA levels. The published data show that at 550 mg at a dose of 1100 mg, the change in viral load from baseline in mild to moderate low-risk patients did not decrease significantly compared with the placebo group, and did not reach the main endpoint of the study.
However, for high-risk patients with underlying health problems (underlying disease), the viral load in the 550 mg and 1100 mg dose groups decreased by 0.5 log10 units relative to baseline at day seven.
Roche and Atea argue that an overly broad selection of patients enrolled in the clinical pool may be the cause of clinical failure, resulting in a small difference compared to the control group. The two parties currently plan to re-evaluate the clinical trial in non-hospitalized patients with COVID-19 after revising the clinical and current patient populations, and data for this trial are expected in the second half of 2022.
At present, in terms of the development of new crown oral drugs, Pfizer, Merck, Japan's Shionoyoshi, Pioneering Pharmaceutical, etc. are also in the layout and in the late stage of research and development, of which Merck has made the fastest progress, announced earlier this month that it has submitted an emergency use authorization (EUA) application for monopivir (English name Moldupiravir) to the FDA, and is also submitting applications to regulatory agencies in other countries around the world, which is expected to become the world's first new crown oral specific drug, and the clinical failure of Roche/Atea new crown oral drug. For Merck's Molnupiravir, it will also be another great opportunity to win the market first.
Molnupiravir is a small molecule broad-spectrum antiviral oral drug against RNA viruses that inhibits replication of the new coronavirus, and interim analysis of the Phase III MOVe-OUT study showed a 50% lower risk of hospitalization or death in non-hospitalized high-risk patients with mild COVID-19. Based on the recommendations of the Independent Data Monitoring Board and the results of communications with the FDA, Merck terminated the Phase III study ahead of schedule and filed an EUA application with the FDA.
In fact, based on confidence in the findings, Merck is already risking early production of Molnupiravir, expecting to be able to produce enough drugs for 10 million courses of treatment by 2021 and will continue to increase the supply of drugs in 2022. In June, Merck signed an agreement with the U.S. government to provide the U.S. government with 1.7 million courses of molnupiravir worth $1.2 billion (about 7.7 billion yuan) once it has been authorized or formally approved by the FDA for emergency use.
In terms of Pfizer, the 3CL protease inhibitor PF-07321332 + ritonavir therapy will usher in phase III data blinding before the end of the year, PF-07321332 plays an important role in the life cycle of multiple coronaviruses, and its potential advantage is that all current variants of the new coronavirus can have a role.
In terms of Yoshinoshi Shiono, Japan, S-217622, which is also a 3CL protease inhibitor, is currently undergoing Phase 2/3 clinical trials in patients with mild or asymptomatic COVID-19 infection.
In the development of the pharmaceutical industry, the androgen receptor antagonist pkrutamine will blind phase III data in mid-November.
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