Zydus Cadila announced that it had received approval from the Mexican regulatory authority COFEPRIS to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHep’. According to the press statement, this will be an open-label, randomized, comparator-controlled study of Pegylated IFN alfa-2b to evaluate safety, efficacy, and tolerability in patients with Covid-19. Clinical and regulatory development of Pegylated Interferon alpha-2b in Covid-19 is being executed in Mexico by Avant Santé Research Center SA de CV, a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico.
Zydus had earlier approached the DCGI to investigate the role of Pegylated Interferon alpha-2b for Covid-19 and the clinical trials are now underway. The company is also working with USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b.
Speaking on the development, Sharvil Patel, managing director, Cadila Healthcare, said, “Our endeavor is to continue looking for pathways for a safe and efficacious treatment to combat Covid-19. Pegylated Interferon-alpha has the potential to reduce virus titers when given earlier in the disease. The focus is on reducing the viral load and generating virus eliminating specific immune response.”
The treatment option emerged after the publication of two recent peer-reviewed research articles. The first one by Ogando et al (Journal of General Virology, June 2020) at Leiden University Medical Center, Netherlands, showed evidence of a direct anti-viral effect of Pegylated Interferon-alpha against novel Coronavirus. The study demonstrated that Pegylated Interferon was able to neutralize SARS-CoV-2 virus in vitro completely. The second by Zhou et al (Frontiers in Immunology, May 2020) from a group of universities in China, Australia and Canada retrospectively analyzed 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, IL6.
How Interferon Alpha 2b works
When the human body contracts an infection due to a viral attack, it produces molecules called Type 1 interferons as the first line of defence. Interferon-alpha is one such Type 1 Interferon molecule that slows down the viral replication and helps activate the two arms of our immune system – Innate, for the 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, which 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.
Zydus has been commercially manufacturing Pegylated Interferon alpha-2b under the brand name, PegiHep, since 2011 for the treatment of Hepatitis B and C with 1.5 lac doses being administered. PegiHep is not yet licensed or approved for the treatment of Covid-19.