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Business

Biocon's partner to not initiate Itolizumab Ph 3 trials, co seeks to modify Ph 4 trials in India

Updated : December 03, 2020 02:55 PM IST

In October, Equillium had said that it had got USFDA clearance to begin a Phase 3 clinical trials.

Biocon's drug Itolizumab has emergency approval for COVID-19 treatment in India.

Biocon’s US partner Equillium Inc has said that it will not initiate Phase 3 clinical trials for Biocon's drug Itolizumab in the US. In October, Equillium had said that it had got USFDA clearance to begin a Phase 3 clinical trials, to evaluate biologic drug Itolizumab in hospitalised COVID-19 patients suffering from acute respiratory distress syndrome.

Equillium said the decision not to go for the phase 3 trials, was based on updates of the efficacy of new potential vaccines, and other treatment options for COVID-19. It said it would prioritise resources in expanding, accelerating study of Itolizumab in other diseases such as aGVHD (acute graft-versus-host disease), lupus, nephritis, and uncontrolled asthma.

Biocon's drug Itolizumab has emergency approval for COVID-19 treatment in India based on data from a small 30-patient phase 2 trial. The drug however has not been included in National COVID-19 treatment guidelines yet as experts feel clinical data on efficacy and safety of the drug is limited.

Biocon had initiated a phase 4 post-marketing surveillance on the drug. The company has now approached the regulator seeking changes in Phase 4 study and intends to include clinical efficacy outcome assessment, along with safety assessment as a primary endpoint of the study.

The minutes of the Subject Expert Committee meeting said the firm needs to submit reasons for this amendment and also submit safety data and mortality data on Itolizumab collected till date.

Nearly 2000 patients have been administered Itolizumab under the Emergency Use Authorisation in India.

Biocon has highlighted that Equillium may consider other options to evaluate Itolizumab in COVID-19 patients including government research initiatives.

Itolizumab, selling under brand name Alzumab is priced at Rs 8,000 per vial. Standard COVID-19 treatment would require the patient to take 4 vials, with the therapy costing Rs 32,000.

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