Themis Medicare receives approval of antiviral drug VIRALEX from Drug Controller General of India

4 Mar 2022 , 09:45 AM

Themis Medicare Limited, Pharmaceutical company headquartered in Mumbai, has received approval for its immunomodulatory antiviral drug Viralex from Drug Controller General of India (DGCI). As per the results of a double-blind randomized controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients.

In line with the DCGI’s current approach for approval of medicines for the management of the ongoing pandemic, approval for VIRALEX (Generic name: Inosine pranobex) is based on the results of the robust phase 2 and phase 3 RCTs conducted in India, and the well-established safety profile of the drug.

As per the results of the Phase 3 Randomized, Double-blind, Placebo-controlled Trial, 80.17% of patients treated with VIRALEX showed clinical improvement on day 6, which is significantly higher (p<0.001) from that in the controlled group(52.38%) among the mild to moderate non-hospitalized COVID-19 patients.

Clinical Cure was also significantly higher in the VIRALEX group as compared to that in the placebo group on day 6 of treatment. There was early improvement and cure from symptoms in patients who received VIRALEX. This drug was well tolerated by the patients without any serious side effects. The study was conducted during the Delta wave of the pandemic.

Randomized, Double-Blind, Placebo-controlled, Multicentre Trial is considered as the clinical research methodology of the highest global standard for evaluating drugs against diseases. Themis is one of the few companies to submit data from a higher number of patients from RCTs for approval in management of COVID19.

After detailed deliberation, the drug regulatory authority granted permission to manufacture and market this new drug for restricted emergency use of the drug as an add on therapy for treatment of mild and moderate COVID-19.

VIRALEX would be available on the prescription.
Based on the promising study results, the drug appears to offer immense clinical benefit to the patients in the early stages of COVID-19, thus reducing the load on the health care system.

VIRALEX is an immunomodulatory agent with broad-spectrum antiviral properties. It enhances both innate & adaptive immunity and strengthens the body’s defence response to viral infections. In an in vitro study initiated by Themis, it showed dose-dependent inhibition of viral replication against SARSCoV-2 (COVID-19).

According to Themis, VIRALEX will be manufactured at an EU-GMP-certified facility with the highest safety standards and stringent manufacturing protocols in place, and the medication will be available in the form of a 500 mg tablet at a much affordable price.

Sachin Patel, Managing Director& CEO of Themis Medicare Ltd. said, “Our endeavor has always been to develop medicines that benefit patients and make healthcare far, far more effective. Given the current scenario of grave health concerns and economic challenges surrounding COVID19 in India, this is our effort to contribute to the wellbeing of people of India”.

“Due to the frequently mutating trend of the virus, the uncertainties of the pandemic continue. We hope access to effective treatment such as VIRALEX will offer a much-needed therapeutic solution, and if initiated early in the disease, it would reduce the load on the health care system.”

Ashok Swain, Head Clinical Development, congratulated the entire Themis Medicare Ltd. team for achieving an important milestone of adding this effective medicine with an established safety profile to address the unmet need in the management of the pandemic.

“VIRALEX is a new ray of hope in these challenging times,” he said.

Raja Dhar, eminent pulmonologist and Director and Head of Department of Pulmonology, C K Birla Hospitals, said “Inosine Pranobex is a drug which enhances host immunity (immunomodulatory effect) and can affect viral RNA and hence inhibits growth of several viruses. Phase 3 Double blind RCTs are rare in COVID 19. I am heartened to hear that Themis Medicare has come up with such a trial, which shows early clinical response and shortened period of recovery when used in mild to moderate COVID 19 cases. This drug, if successfully used in clinical practice would considerably reduce the burden on health care system.

At around 9.48 am, Themis Medicare Ltd was trading at Rs989 per piece down by Rs18.25 or 1.81% from its previous closing of Rs1,007.25 per piece on the BSE.