Zydus successfully completes Phase II clinical trials of its biological therapy ‘Pegylated Interferon alpha2b’ on COVID-19 patients ; To start Phase-III trials soon
Pegylated Interferon alpha – 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients; the Company will now commence Phase III clinical trials
Biznextindia : Indian pharma major Zydus Cadila on Thursday announced that it has successfully completed a Phase 2 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’.
In this open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and 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 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 hospitalization, ventilation, supplemental oxygen etc. The study established the early safety, efficacy and tolerability of PegiHepTM in moderate COVID-19 patients. 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.
“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” Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd. Said.
Pegylated Interferon alpha-2b is not a new therapy. 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, PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients. Given that type I interferons including Interferon alpha have been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science (Hadjadj et al, Bastard et al and Zhang et al), the findings in Zydus Cadila’s Phase 2 study are not surprising. 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.
Zydus Cadila had conducted this study on the approval from the DCGI to investigate the role of Pegylated Interferon alpha-2b for COVID 19. 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.