Cadila Shares Gain On Completing Phase-II Trials Of Covid-19 Therapy
Cadila will now begin phase-3 clinical trials in India.
Shares of Cadila Healthcare Ltd. pared all of their opening losses to trade higher after the drugmaker said it has successfully completed a study evaluating early safety, efficacy and tolerability of a key Covid-19 drug.
Zydus Cadila has successfully completed a phase-2 clinical trial in Covid-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHep’, which significantly increased viral reduction and reduced the need for supplemental oxygen in patients with moderate symptoms, according to an exchange filing. The company will now begin phase III clinical trials in India.
Reacting to the development, shares of Cadila recovered from the day’s low to gain as much as 4.55% at Rs 435.40 apiece. The stock finally ended 2.3% higher at Rs 426.05. The volumes on the stock today were 67% higher than its 20-day average.
The phase-2 trial was an open-label, randomised, comparator controlled study, involving 40 adult patients with moderate Covid-19 disease. Ninety-five percent of the subjects in the test arm who received a single dose of PegiHep, along with standard of care, became virus free as assessed by RT-PCR on day 14. That, it said, 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 the treatment.
“Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we would like to explore this biological option further,” Sharvil Patel, managing director at Cadila Healthcare, was quoted as saying in the filing.
The company is also conducting similar phase-2 trials in Mexico. It is working with the U.S. Food and Drug Administration to open an investigational new drug application for the said therapy in order to initiate appropriate clinical trials in America.