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NovaLead To Commence Phase-3 Trial On About 100 Moderate COVID-19 Patients

It could well be a breakthrough in the field of repurposed drug discovery in the fight against COVID 19 pandemic in a cost-effective and affordable way.

Written By
Suman Ray

It could well be a breakthrough in the field of repurposed drug discovery in the fight against COVID 19 pandemic in a cost-effective and affordable way.

Novalead Pharma, a Pune based leading drug repurposing company which has received clinical trial approval from DCG(I) for its Repurposed Drug discovery to treat moderate COVID-19, commence Phase-3 trial on about 100  COVID-19 patients shortly.

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"To establish its efficacy in COVID-19, NovaLead shall be commencing Phase-3 trial soon on about 100 COVID-19 patients in about six hospitals in India. The patients who provide informed consent and qualify for the inclusion/exclusion criteria of the study shall be enrolled. We expect to commence the trial in 3-4 weeks. This time is needed to identify hospitals with clinical trial expertise, necessary infrastructure and obtaining approvals from their Ethics Committees.Subject to the successful outcome in the Phase-3 clinical trials, the completion of the study is expected in 3-4 months from its commencement. And if so, DCGI who is already burning midnight oil would allow a priority review of the data for approval," Supreet Deshpande, CEO of Novalead Pharma told Republic TV on a Live Broadcast on Saturday.

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Giving a backgrounder of why and how the company planned to work in this area, Deshpande said: "With our ability to repurpose drugs for difficult to treat disease like the diabetic foot ulcer, we felt obligated to work on novel coronavirus. We took research on COVID-19 on priority. Our aim was to find approved, safe and affordable drugs which would have ability to address COVID-19 and can help the masses if successful in the human trials. We studied about 2183 approved drugs against 36 protein targets involved in spread of viral infection. The research showed that the drug which we have masked as NLP21 has potential to address COVID-19 through multiple ways in the human body"

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This drug is available in some pharmacies. Upon knowing the name, people may rush to buy it and start using even before the Phase-3 trial is completed. Even though the drug is very safe, we do not recommend such thing till its effectiveness in human trial is established. Therefore, we are masking the name of the drug for now. The safety of the drug is well established as it is in human use for years without side effects of concern."

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