Zydus receives approval for Phase III clinical trials with Pegylated Interferon alpha-2b in India

Pegylated Interferon alpha – 2b increased viral reduction in moderate Covid-19 patients

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Zydus Cadila recently announced that it had 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, ‘PegiHep’. The trials, which will begin in December, will be conducted on 250 patients across 20-25 centers in India. In Phase II, clinical trials study established the early safety, efficacy, and tolerability of PegiHep and has indicated that Pegylated Interferon alpha-2b having a statistical, clinical beneficial impact on the patient suffering from moderate Covid-19 disease 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. Pegylated Interferon alpha-2b, ‘PegiHep is an approved drug and is being re-purposed for the treatment of Covid-19.

Speaking on the development, Sharvil Patel, managing director, Cadila Healthcare, 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 titers 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 an open-label, randomized, comparator-controlled study involving 40 adult patients with moderate Covid-19 disease, 95% of 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.

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 to initiate appropriate clinical trials in the 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 initially approved for Hepatitis C and was launched in the Indian market in 2011. Since then, safe and efficacious drug use for this product has been demonstrated in thousands of patients.

Given that type I interferons including Interferon-alpha have been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science (Hadjadj et al, Bastard et al and Zhang et al), the findings in Zydus Cadila’s Phase 2 study are not surprising. In this study, a single dose of PegiHep at 1 mcg/kg body weight was tested to determine whether the drug could be repurposed for treating moderate Covid-19 patients. In 19 out of 20 patients, a single 1 mcg/kg dose of the drug demonstrated viral clearance assessed by RT-PCR and a significant improvement in clinical symptoms.

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