World's First Biologic Treatment for Covid-19 Approved

- Biocon's psoriasis treatment repurposed to fight covid-19
- Acts by fighting cytokine storms
- Only suitable for moderate to severe covid-19 infections

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Pharmaceutical company Biocon have announced one of their drugs used to fight psoriasis has been approved to fight moderate to severe covid-19 infections in patients.

Biocon is an India-based Pharma company who in 2013 launched itolizumab as a novel humanised anti-CD6 monoclonal antibody for the treatment of psoriasis in India.

Itolizumab is designed to quell the body's hyper immune response that causes psoriasis, which researchers saw as being a potential avenue to treating severe covid-19 infections which is also ultimately the result of an overreaction by the immune system.

“Itolizumab acts by binding to CD6 receptor and down-regulating T-cell activation leading to suppression of pro-inflammatory cytokines, thereby reducing cytokine storms. Thus, the drug must be administered with caution, and only to moderate to severe patients only and not in the early stage of the disease," says Nag Madhavi, Pharma Analyst at GlobalData.

The drug has been approved by India's health authorities based on Phase II results from the randomised controlled trials, with thirty patients across four hospitals in Mumbai and Delhi.

At the end of first month, 20 patients on itolizumab were discharged whereas three out of 10 patients on best standard of care died.

"This immunomodulator has been repurposed for the treatment of COVID-19 as cytokine storms or acute inflammatory responses are considered to be one of the main drivers of mortality in COVID-19 patients," says Madhavi.

Crucially the treatment costs less than Gilead Science's Remdesivir, meaning an alternative treatment to remdesivir for poorer nations might be forthcoming. Itolizumab is an intravenous therapy priced at US$106 per vial, and the overall treatment cost is estimated to be US$426.

By comparison, Gilead Sciences announced in an open letter on Monday morning that it has decided to set a price of $390 per vial for Remdesivir in the U.S., meaning a typical five-day treatment course would include six vials, which would equate to $2,340 per patient.

Itolizumab is only approved for use in India, but Biocon have announced their partner Equillium will conduct global clinical trials of itolizumab for COVID-19.

"It is the first biologic in the world to get approval for COVID-19 complications; however, its use is associated with certain conditions and hence requires informed consent from the patients and an effective risk management strategy. DCGI has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19," says Madhavi.

According to the GlobalData COVID-19 dashboard, as of 14 July 2020, India has 878,254 confirmed cases, and the dashboard forecasts 2,648,425 confirmed cases in India in a low transmission risk scenario by 20 July 2020.

Even though the trial results indicate a reduction in mortality, there are concerns over itolizumab’s efficacy due to the low number of patients enrolled for the trial.

"Hence, this could be a limiting factor for its usage,” says Madhavi.