Biocon Biologics’ re-purposed drug, Itolizumab, is getting a fresh lease as the second wave of Covid-19 rages on. The drug is undergoing Phase 4 trials.
A company spokesperson told BusinessLine that the company is progressing well with the already announced Phase 4 studies in India and has enrolled more than 100 patients of the 300 required.
“Under the emergency use, over 2,000 patients in India have benefited from Itolizumab administration. We will also explore potential opportunities for this asset across other emerging and developed markets as an effective Acute Respiratory Distress Syndrome (ARDS) treatment,” she said.
Itolizumab, an anti-CD6 novel biologic for psoriasis, was repurposed by Biocon Biologics in 2020 for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe ARDS patients due to Covid-19.
The drug has completed Phase 3 trials and market surveillance, and the Phase 4 clinical trials are on after approval from the Drug Controller General of India (DCGI) in September 2020. Biocon Biologics has enrolled patients across 15 centres.
Demand across India
The demand for Itolizumab is coming from across India. “The infection surge is seen most in Maharashtra, Gujarat, Karnataka, Delhi, UP, Bihar, Jharkhand, MP, Chhattisgarh, Andhra Pradesh, and Telangana, which account for 75-80 per cent of the caseload,” said the spokesperson. “We are addressing these requests in the best possible manner and till now we have addressed the needs of around 5,500 patients across India,” she added.
Covid-19 products
The company has also come out with a dedicated 24x7 pandemic-care helpline to give information on the availability of its Covid-19 products and other such queries. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon tweeted the availability of 24x7 Covid-care helpline and shared it on LinkedIn. Mazumdar, in the analysts’ third quarter earnings call, had said, “Equillium, our US-based partner, is making steady progress in Phase 1b clinical trials for Itolizumab in the firstline treatment of acute graft-versus-host disease (aGVHD). The overall Phase 1b top-line data is expected during the first half of 2021. As you know, aGVHD has a vast unmet need, and we believe that Itolizumab is well-positioned to address this need.”