Cadila completes Phase-II trials of Covid-19 treatment therapy

Our Bureau Ahmedabad | Updated on November 12, 2020

Cadila Healthcare Ltd on Thursday announced successful completion of the Phase-II clinical trial of its biological therapy Pegylated Interferon alpha-2b, ‘PegiHep’ on Covid-19 patients, paving the way for company to begin Phase 3 trials in India.

The company informed that the open-label, randomised, comparator controlled study, which involved 40 adult patients with moderate Covid-19 disease, established the early safety, efficacy and tolerability of PegiHep in moderate Covid-19 patients.

Also read: Zydus Cadila files investigational new drug application for Covid-19 treatment

In this study, a single dose of PegiHep at 1 mcg/kg body weight was tested to find out 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 as assessed by RT-PCR and a significant improvement in clinical symptoms.

“The study so far has indicated that Pegylated Interferon alpha-2b could have a 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 therapy will improve compliance and also make it highly affordable for patients,” company said in a statement.

It also stated that 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. 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 hospitalisation, ventilation and supplemental oxygen.

Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said, “We continue to look at possible treatment options that are safe and efficacious in the treatment and management of Covid-19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight Covid-19.”

Pegylated Interferon alpha-2b is not a new therapy. It 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.

Phase 3 trial on cards

Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a Phase 3 clinical trial in India. The company 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 US.

Cadila Healthcare is already working on Covid-19 vaccine candidate — ZyCov-D and hopes to start phase III trials by December.

Cadila Healthcare shares gained 2.39 per cent on BSE to close at ₹426.10 on Thursday.

Published on November 12, 2020

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