Zydus Cadila has received approval from the Drugs Controller General of India (DCGI) to start the final phase clinical trials in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHep'. The trials will commence in December and will be conducted on 250 patients across 20-25 centres in India, said Zydus Cadila.
It said the Phase 2 studies among 40 patients established the early safety, efficacy, tolerability and has helped in reducing viral load in COVID-19 patients.
"In the Phase 2 clinical trials study established the early safety, efficacy and tolerability of PegiHep and has indicated that Pegylated Interferon alpha-2b having 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," the drug maker said in a press release.
The company said that a single dose therapy will improve compliance and also make it highly affordable for patients.
Zydus Cadila is also conducting a similar Phase 2 trial in Mexico. The company is also working with the USFDA to start an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.
Pegylated Interferon alpha-2b, 'PegiHep is being re-purposed for the treatment of COVID-19. 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 originally approved for Hepatitis C and was launched in the Indian market in 2011.
"We are encouraged by the results of Phase 2 study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease and 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," said Dr. Sharvil Patel, Managing Director.
In the Phase 2 clinical trial which was open-label, randomised, 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. It also showed a statistically significant clinical improvement over the patients in the reference arm, who received only standard care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative, said Zydus, which is developing two vaccines for COVID-19.