The Phase 2 trials were conducted across Postgraduate Institute of Medical Education and Research, Chandigarh, All India Institute of Medical Sciences (AIIMS) Delhi, and AIIMS, Bhopal.
As the race to find treatment or vaccine for Covid-19 hots up, Ahmedabad-based Cadila Pharmaceuticals and the Council of Scientific and Industrial Research’s (CSIR’s) Sepsivac is all set to enter Phase 3 clinical trials after the earlier phase showed positive results.
The public-private partnership trial-generated data will be soon presented before the country’s drug regulator to see if it can get emergency-use authorisation.
“By July 15, we will have the necessary data from the Phase 2 trials and again approach the regulator to see if this drug can be given emergency-use authorisation in the wake of the pandemic. Meanwhile, we also have the approval in place to start two Phase 3 trials — one on 600 patients, another on 500 patients — for this drug,” said Ram A Vishwakarma, director, CSIR-Indian Institute of Integrative Medicine.
The Phase 2 trials were conducted across Postgraduate Institute of Medical Education and Research, Chandigarh, All India Institute of Medical Sciences (AIIMS) Delhi, and AIIMS, Bhopal. For the third phase, two more sites will be added — AIIMS
Raipur and a Banaras Hindu University institute.
Sepsivac is an immunomodulator drug. Researchers feel the drug works in a two-pronged approach. One, it kick-starts the innate immunity system to act against the pathogen. Two, it also works to reduce the release of inflammatory Cytokine IL-6 that attacks internal organs.
Vishwakarma explained that Sepsivac is not an antibody-generating vaccine. “It can be called a therapeutic vaccine that will kick-start the innate immunity. There are two kinds of immunity in our body — innate immunity that we are born with and get from our ancestors and there is the acquired immunity. Acquired immunity is mostly governed by antibodies,” said Vishwakarma.
Whenever a virus or bacteria attacks our body, the innate immunity or trained immunity first reacts. “We are boosting this trained immunity or what we call scientifically, Th1 (T helper type 1). It reacts in most patients, which is why they get cured. In some with comorbidities, their immune system is already compromised,” said Vishwakarma.
Given in the early phase of infection, it protects the patient from infection. The second way in which this drug works is by inhibiting the IL-6 or inflammatory cytokine.
“Most of the damage happens due to this in IL-6 in patients. A Roche drug Tocilizumab works in this manner. Sepsivac or Mycobaterium w also stops the release of IL-6 which would control the multi-organ damage. A patient’s innate immunity then has an opportunity to protect him,” he explained. Mycobaterium w is not a SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) virus-specific immunity.
Further, in the Phase 3 trial, the plan is to give the drug to a group of 500 patients after they have recovered from the virus, so that they do not redevelop the disease in future.