Covid-19 vaccine: Biocon’s US partner Equillium to withdraw Itolizumab trials

Our Bureau | | Updated on: Dec 06, 2021

US company says it will not initiate Phase-3 clinical trials after reviewing its efficacy

Biocon, a global biopharma company, has faced a setback as its US partner Equillium, a clinical-stage biotech company, announced that it will not initiate the Phase-3 clinical trial to evaluate Itolizumab in hospitalised Covid-19 patients in the US.

Bruce Steel, Chief Executive Officer of Equillium, in a statement said: “Based on a thorough review of recent updates regarding the efficacy of new potential vaccines and other treatment options, we have made the strategic decision not to initiate our Phase-3 trial as previously planned. We are continuing to assess the rapidly evolving clinical and commercial landscape related to this pandemic and may consider other options to evaluate Itolizumab in Covid-19 patients, including government research initiatives.”

In 2017, Equillium had originally secured exclusive rights to develop and commercialise Biocon’s Itolizumab, for the US and Canada markets and later extended it to include Australia and New Zealand within the scope of the licensing agreement.

Early this year, Equillium got USFDA clearance to conduct Phase 3 trials to evaluate itolizumab in hospitalised Covid-19 patients suffering from respiratory distress syndrome (ARDS).

Expanding aGVHD programme

Steel said, “Based on recent positive itolizumab interim clinical data in acute graft-versus-host disease (aGVHD) we plan to prioritise our resources on expanding and accelerating this programme, as well as advancing our lupus/lupus nephritis and uncontrolled asthma studies. We look forward to providing additional pipeline updates at our Analyst Day on December 4.”

Published on December 03, 2020
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