Zydus gets DCGI’s approval for phase III clinical trials of its COVID-19 biotherapy

According to the company, Pegylated Interferon alpha – 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients

New Delhi: In an important development, Zydus Cadila has received approval from the Drugs Controller General of India (DCGI) to start the Phase 3 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b. Called ‘PegiHep’, it is an approved drug, now being re-purposed for the treatment of covid.
Commencing in December, trials will be conducted on 250 patients across 20-25 centres in India. The Phase II clinical trials study established the early safety, efficacy and tolerability of PegiHep and have indicated that Pegylated Interferon alpha-2b having statistical clinical beneficial impact on the patient suffering from moderate COVID 19 disease. It works by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose of therapy will improve compliance and also make it highly affordable for patients.
In her comments, Sharvil Patel, Managing Director, Cadila Healthcare mentioned, “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 Phase 2 clinical trial which was open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% 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% 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. 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 2 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 the US.