AHMEDABAD: At a time when companies and research organizations across the world are racing to find a cure for Covid-19 pandemic, Ahmedabad based Cadila Pharmaceuticals, in partnership with India’s premier research organization Council of Scientific and Industrial Research (CSIR), seems to be on the path of a major breakthrough.
After successful testing on four SARS-CoV-2 patients, including one critically ill, the Phase III clinical trials for the immunomodulator, Sepsivac, is set to begin this week, according to two officials close to the development. And if everything goes as planned, the immunomodulator will be out in the market in less than two months, they added.
The drug is manufactured by at the Cadila Pharmaceuticals facility in Dholka, on the outskirts of Ahmedabad. Under a public private partnership platform, Cadila Pharma and CSIR have decided to repurpose Sepsivac, which is used for treatment of leprosy and is considered a game changer for patients suffering from gram-negative sepsis.
Recently, four Covid-19 patients, including one who was critically ill, all admitted at Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, recovered after being treated with Sepsivac. The Drug Controller General of India (DGCI) has already shown a green light for conducting human trials, said sources. Company officials had recently in a video conferencing with 70 leading pharma stockists from across the country, updated them about the success of Sepsivac on Covid-19 patients.
“The trials will be held simultaneously on 50 critical patients, 480 non-critical patients and 4,000 persons who are have high chances of being infected, including healthcare workers, safai kamdaars,etc,” said an industry official. The recruitment process for conducting the trials will soon begin, he added. Multiple hospitals in the country have been roped in for conducting clinical trials including the All India Institute of Medical Science (AIIMS), New Delhi.
Sepsivac is used to modulate the immune system by lessening the probability of the cytokine storm and as a result it reduces the chances for mortality while improving the healing process. CSIR researchers have found similarity between the clinical characteristics of Covid-19 patient symptoms and gram-negative sepsis.
The drug uses the Mycobacterium w (formally known as mycobacterium indicus pranii) as it produces a different immune-system response. The Dholka facility already has a stock of 50,000 Sepsivac vaccines and it can be scaled up to meet the expected demand, said a senior company official. He said that Cadila Pharma was perhaps the first Indian company to start clinical trials on large groups.