Aurobindo Pharma, MSN seek CDSCO panel nod to cease Molnupiravir trial on moderate COVID patients
New Delhi: Seeking approval to end the study of Merck & Co's experimental antiviral drug Molnupiravir in moderate Covid-19 patients, two Indian pharmaceutical companies, Aurobindo Pharma and MSN Laboratories, have separately sought permission from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to continue the Phase III trial in mild COVID patients.
However, the expert panel, in response to the aforesaid proposal, advised both firms to submit the request in writing to CDSCO for further consideration.
The recommendation came after Aurobindo Pharma and MSN Laboratories presented the interim clinical trial data of Merck & Co's experimental antiviral drug molnupiravir in moderate Covid-19 patients at the 187th SEC meeting to examine COVID-19 related proposals under the accelerated approval process held on October 4, 2021 at CDSCO.
A source with the Drug Controller General of India (DCGI) stated in this regard that the pill has not shown "significant efficacy" against moderate Covid
-19, though it was having success against mild cases, reports Reuters.
In connection with the above, it is worth mentioning that Merck earlier this year suspended its own development of molnupiravir as a treatment for hospitalised COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help.
However, as per the Reuters report, the Indian companies, Aurobindo Pharma Ltd and MSN Laboratories, did not exclude hospitalised patients in designing their moderate COVID-19 trials, according to study documents, although it was not known if the trials ultimately included people in the hospital.
In this regard, Merck spokesperson Melissa Moody said Merck and the Indian companies had defined "moderate" disease differently.
Merck's trials are based on U.S. Food and Drug Administration definitions, which for moderate COVID-19 describe blood oxygen levels as no lower than 93%. It defines blood oxygen levels for severe COVID-19 as 93% or lower.
The trials in India define moderate COVID-19 blood oxygen levels as 90% to 93%, according to the trial documents for the two companies.
Aurobindo and MSN are continuing to conduct studies of molnupiravir in patients with mild COVID-19 who have not been hospitalized, according to trial documents and the website of the Indian drug regulator's internal expert committee.
Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics.
Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced last week that their investigational oral antiviral Molnupiravir reduced the risk of hospitalisation or death by approximately 50% compared to placebo in a positive interim analysis of a phase 3 study for patients with mild or moderate COVID-19.
At a recent SEC meeting, the committee reviewed the proposals of two Indian pharmaceutical majors to discontinue their Molnupiravir Phase III trials in moderate COVID-19 patients and continue the Phase III trials in mild COVID patients.
After detailed deliberation, the committee opined that both firms should submit the above in writing to CDSCO for further consideration.
According to the Reuters report, an Aurobindo spokesperson did not comment on the effectiveness of the drug in its trial. However, the spokesperson said the company had "faced challenges in patient recruitment at this juncture" for its trial in moderate COVID-19 patients, adding "we are evaluating the further course of action."
Aurobindo started the planned 100-patient trial of its generic version of the Merck pill against moderate COVID-19 in August, and is also running a trial that hopes to include 1,200 patients testing the pill against mild disease.
Merck has entered into voluntary licencing agreements with at least eight Indian drugmakers for molnupiravir, with the aim of turning the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income nations.
Five of the eight Indian companies-Dr. Reddy's Laboratories, Cipla, Sun Pharma, Torrent Pharmaceuticals, and Emcure Pharmaceuticals-are conducting a joint trial for the antiviral drug only in mild COVID-19 patients in an outpatient setting.
The other licenced company, Hetero, in early July announced interim data from its own late-stage trial of generic molnupiravir in mild COVID-19 patients and submitted an application to regulators for its emergency use.