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Cadila Healthcare Ltd (Zydus Cadila) on Friday announced that the company's biological therapy, Pegylated Interferon alpha-2b — ‘PegiHep' — has received approval from the Drugs Controller General of India (DCGI) to start phase-III clinical trials.
The trials will commence soon and will be conducted on 250 patients across 20-25 centres in India, the company said.
Pegylated Interferon alpha-2b is an approved drug and is being re-purposed for the treatment of Covid-19.
The phase-II clinical trials established early safety, efficacy and tolerability of PegiHep. It indicated that Pegylated Interferon alpha-2b has shown statistical clinical beneficial impact on the patient suffering from moderate Covid-19 infection by reducing their viral load and helping in better disease management such as reduced duration of oxygen support.
Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients.
Speaking on the development, Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said, “We are encouraged by the results of Phase-II study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease. Our efforts are to look at possible treatment options to fight Covid-19 which are safe, can be administered easily and also reduce the disease burden.”
In the phase-II clinical trial which was open-label, randomised, comparator controlled study, involving 40 adult patients with moderate Covid-19 disease, 95 per cent subjects in the test arm who received a single dose of PegiHep along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14. And showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68 per cent patients showed an improvement in clinical symptoms and became RT-PCR negative.
In the test arm, 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm, Cadila statement said.
Clinical improvement was assessed using a seven-point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc.
Zydus Cadila is also conducting a similar Phase-II trial in Mexico. The company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.
Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List.
Zydus Cadila’s Pegylated Interferon alpha-2b, PegiHep, was originally approved for Hepatitis C and was launched in the Indian market in 2011.
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