In a landmark development for the treatment of COVID-19, Themis Medicare Ltd. (Themis), a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available, announced the approval of its antiviral drug VIRALEX by the Drug Controller General of India (DCGI).

As per the results of double-blind randomised controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients. Viralex has been found to be effective and well-tolerated in mild to moderate COVID-19, in two Randomised Controlled Clinical Trials conducted on 499 Indian 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: Inosinepranobex) is based on the results of the robust phase 2 and phase 3RCTs conducted in India, and the well-established safety profile of the drug.

As per the results of the Phase 3 Randomised, 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-hospitalised 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.

Randomised, 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 COVID-19.

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 the 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 healthcare system.

Viralex is an immune-modulatory agent with broad-spectrum antiviral properties. It enhances both innate & adaptive immunity and strengthens the body's defence response to viral infections. In an invitro study initiated by Themis, it showed dose-dependent inhibition of viral replication against SARS-CoV-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 more affordable price. Speaking at the release, Dr Sachin Patel, Managing Director & CEO of Themis Medicare Ltd. said, Our endeavour 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 COVID-19 in India, this is our effort to contribute to the well being of the 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 healthcare system.

Commenting on the significance of this development, Dr 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. Dr Raja Dhar, eminent pulmonologist and Director and Head of Department of Pulmonology, C K Birla Hospitals, said Inosine Pranobexisa drug which enhances host immunity (immune-modulatory effect) and can affect viral RNA and hence inhibits the 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 a shortened period of recovery when used in mild to moderate COVID19 cases. This drug, if successfully used in clinical practice would considerably reduce the burden on the healthcare system.

Dr Dhar is also the current Chair of Training and Education Initiatives, Indian Chest Society, and Director of Research and Training, National Allergy Asthma Bronchitis Institute. With a strong R&D backup, skilled domestic & export teams, and 4 state-of-the-art manufacturing sites, the endeavour at Themis has always been to support the medical fraternity with solution forms or unmet medical needs like Viralex for COVID-19 and still counting!