Biocon initiates global phase-3 trials for Itolizumab, holds meeting with USFDA

Anil Urs Bengaluru | Updated on October 23, 2020 Published on October 23, 2020

In India, it commences enrolment for a 300-patient, phase-4 clinical study across 15 centres

As Biocon’s repurpose drug — Itolizumab — progresses to phase-4 clinical trials in India for Covid-19 treatment, its partner, Equilium, has held Pre-IND (New Drug Application) meeting with the United States Food and Drug Administration (USFDA) for global phase-3 clinical trials.

A pre-IND meeting is to ensure that the drug development plan and future clinical trials are acceptable to the USFDA.

The phase-4 clinical study in India is being conducted to generate a larger body of scientific evidence to support the safety, efficacy and usefulness of Itolizumab. Itolizumab, is an anti-CD6 novel biologic for psoriasis, the drug is repurposed for the treatment of Cytokine Release Syndrome in moderate to severe acute respiratory distress syndrome patients due to Covid-19.

“Equilium, our US partner for our drug Itolizumab, recently received positive feedback during its Pre-IND meeting with USFDA and is advancing along a regulatory pathway in preparation in initiating global phase-3 clinical trials in Q4 of Calendar 2020,” Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, told analysts.

“Back home we have initiated phase 4 clinical trials on approval from the Drug Controller General of India (DGCI) in September 2020 for our drug Itolizumab. We have commenced enrolment for a 300-patient, phase-4 clinical study across 15 centres,” she added.

Kiran Mazumdar-Shaw said the US, on the other hand, does not have an approved drug in the US. “It is under trials right now, they are actually doing phase 1b studies, GVHt and for acute asthma. So I think from that point of view they are required then do Phase 3 study, in fact, they have been given the very unique opportunity to jump into a Phase-3 study which under the present circumstances it is actually a very good opportunity for Equilium to do a phase 3 study and get approval for this drug.”

The development augurs well for Equilium and is expected to commence its trials shortly. “Now it all depends on the recruitment of patients which will then determine how quickly they can complete the study,” she added.

Sharing development of Itolizumab in India, she said “As you know Itolizumab is an approved product in India. So in India, it is a re-purpose approved drug. This has already gone through phase 1, 2 and 3 for approval for psoriasis so from that point of view, what we have done is a proof of concept study for another indication on which we have got emergency use approval for Covid-19.”

“The regulator has asked us to do Phase-4 study because of this accelerator approval it has given us for this short study to basically to capture safety and efficacy data on 300 patients. So this is what is required in terms of a regulatory requirement,” she added.

On a question for once approved, will it be for emergency use or could it be sold to anyone, Kiran Mazumdar-Shaw said: “Right now we are already selling it for psoriasis patients, it is an approved drug. For Covid indications, basically, you are allowed to sell it to anyone. Basically with consent, one can sell it to any patient. Initially, we had capacity constraints and sold the product to over 2,000 patients in the country.”

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Published on October 23, 2020
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