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Biocon Biologics’ repurposed drug, Itolizumab, is getting a fresh lease as the second wave of Covid-19 rages on. The drug is nearing completion of Phase 4 trials.
A company spokesperson told BusinessLine that the company has recruited all 300 patients for the phase 4 study and data is being analysed to be presented to the regulator.
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 had received Emergency Use Authorization from DCGI in July 2020 and several thousand patients have benefited from it. The Phase 4 clinical trials after approval from the Drug Controller General of India (DCGI) were initiated in September 2020, entailing 300 patient recruitments across multiple centres.
Demand across India
The demand for the company’s Itolizumab is coming from across India. “The infection surge is seen most in Maharashtra, Gujarat, Karnataka, Delhi, UP, Bihar, Jharkhand, MP, Chhattisgarh, Andhra Pradesh, Telangana which accounts for almost 75-80 per cent of the patient caseload” said the spokesperson.“We are addressing these requests in the best possible manner and till now we addressed the needs of around 5,500 patients across India,” she added.
Covid-19 products
The company has come out with a dedicated 24x7 Covid Care Helpline to dish out information on the availability of the company’s Covid-care products and other 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 first-line 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.”
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