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Business News/ Companies / News/  RedHill Biopharma seeks India’s nod for its Opaganib oral covid-19 drug
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RedHill Biopharma seeks India’s nod for its Opaganib oral covid-19 drug

RedHill said opaganib has the potential to address the Omicron SARS-CoV-2 variant as it works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations

The pharmaceutical company is pursuing development program for opaganib across the world. It has submitted data packages to the US FDA, the European Medicines Agency, and the UK (MHRA). Photo: Ramesh Pathania/Mint Premium
The pharmaceutical company is pursuing development program for opaganib across the world. It has submitted data packages to the US FDA, the European Medicines Agency, and the UK (MHRA). Photo: Ramesh Pathania/Mint 

NEW DELHI : Israel-based RedHill Biopharma on Tuesday said it is pursuing the submission of clinical trial data in India for approval of Opaganib, an oral covid-19 drug it claims has potential to address the Omicron SARS-CoV-2 variant. The company said the drug works by targeting the human host cell rather than the virus itself, and is, therefore, not expected to be impacted by spike protein mutations. 

India has already recorded over two dozen cases of Omicron. Increased hospitalizations in South Africa due to Omicron have highlighted the urgent need for drugs aimed at “moderately severe" covid-19 patients with pneumonia requiring hospital treatment. “By focusing on this large group of patients, Opaganib, if approved, would target an entirely different and sicker patient population than the Pfizer and Merck oral drug candidates, which showed benefit only in non-hospitalized patients at the earliest stages of symptomatic infection," RedHill Biopharma said in a statement. 

The pharmaceutical company is pursuing the development programme for Opaganib across the world. It has submitted data packages to the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK (MHRA), actively seeking scientific advice on the potential path towards approval of Opaganib. “The EMA has indicated a rapid procedure timeline, and we expect their advice by end of the year, with preliminary feedback from the FDA expected in January 2022," the company statement said. 

The preliminary results of phase-II or -III clinical trials being done in US, in a subpopulation of patients defined as moderately severe based on their level of baseline oxygen supplementation, showed that mortality was 62% lower in those using Opaganib. 

RedHill’s other oral covid-19 drug candidate is a once-daily oral capsule, given early in the course of the disease, to outpatients. It targets serine proteases, which are human enzymes involved in facilitating the entry of SARS-CoV-2 into target cells. RHB-107 is currently being evaluated in a phase-II or -III study in non-hospitalized covid-19 patients in the US and in South Africa. Recruitment for part A of the study has been completed and top-line results are expected in the first quarter of 2022. 

“Both Opaganib and RHB-107 have unique human cell-targeted mechanisms of action that act independently of mutations at the spike protein. Given the gravity of the threat presented by Omicron, and the likely emergence of other variants, RedHill is pursuing development of these two promising covid-19 pills as quickly and diligently as possible. We have extensive safety data and, in the case of Opaganib, an apparent clinical benefit in reducing mortality, getting patients back on to room air and getting them out of hospital faster," the company’s research and development head Gilead Raday said. 

RedHill Biopharma is also pursuing submission in other countries including South Africa, Russia, Israel, Switzerland, Brazil, and Colombia.

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Published: 07 Dec 2021, 04:41 PM IST
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