Cadila Healthcare says exploring cancer, hepatitis drug Interferon alpha-2b for COVID-19

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26 Aug, 2025 12:21

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Drugmaker Cadila Healthcare on April 20 said it had approached Department of Biotechnology (DBT) to investigate the role of long-acting Interferon alpha-2b for COVID-19.

The Ahmedabad-based drugmaker said it is ready to undertake clinical trials based on the government's response.

The company is also working with USFDA to open an Investigational New Drug (IND) filing for Pegylated (long-acting) Interferon alpha-2b and explore the possibility for “Compassionate Use Program”.

Compassionate use refers to an unapproved drug or medical device still under investigation, given to patients under special circumstances such as those suffering from a serious or life-threatening disease with no available medication, like in the case of COVID-19.

Before the drug is allowed for compassionate use, the company's new drug application (IND) has to be accepted by USFDA. In normal times filing an IND takes months. The regulatory agency will seek data related to pre-clinical or animal toxicology studies, before allowing the drug to proceed to human trials.
Interferon alpha-2B is a biologic drug used in the treatment of cancers and hepatitis-B and C infections.

Pegylated Interferon alpha-2b, ‘PegiHepTM’
can emerge as one of the pathways to treat COVID-19. The treatment has emerged after the publication of two non-peer reviewed research articles at bioRxiv and medRxiv.

The first one by the University of Texas Medical Branch, Galveston, showed evidence of a direct anti-viral effect of Interferon alpha against novel Coronavirus in vitro. The study demonstrated around 10,000 fold reduction in the quantity of virus that was pre-treated with Interferon alpha 48 hours earlier.

The second by a group of universities in China, Australia and Canada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6.

"This suggests that if a long-acting molecule-like Pegylated Interferon alpha is given early on in the infection, the patient suffering from COVID-19 will have a significant benefit as the viral load is reduced, lesser IL-6 is produced and virus eliminating specific immune response is generated," Cadila Healthcare said in a statement.

When the human body contracts an infection due to a viral attack, it produces a group of molecules called Type 1 interferons as the first line of defence. Interferon alpha is one such Type 1 Interferon molecule, that not only slows down the viral replication but also helps activate the two arms of our immune system – Innate, for an immediate killing of the virus and Adaptive, for long-lasting immunity.

To make it more effective, the molecule is coupled with polyethylene glycol to produce a new molecule called, Pegylated Interferon alpha, that has the same functionality as Interferon alpha but remains in the body
longer and therefore, requires only once-a-week injection, thus providing a much better efficacy profile.

Cadila Healthcare has been at the forefront of the fight against COVID-19. The company is one of the world's largest producer of anti-malarial drug hydroxychloroquine which is widely used as a prophylactic drug to prevent COVID-19 infections. The company is also developing two vaccines against COVID-19 in house.