Equillium and Biocon Announce Positive COVID-19 Data for Plaque Psoriasis Drug Itolizumab

Itolizumab showing positive results in COVID-19 patients 

Maybe, just maybe, there will be another drug to treat COVID-19. Equillium announced that its partner, Biocon, reported data from a clinical trial showing that itolizumab significantly decreased mortality in hospitalized COVID-19 patients. The clinical trial was conducted in India by Biocon. Equillium is headquartered in La Jolla, California. Biocon is based in Bengaluru, India.

Itolizumab is a first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway is central to modulating the activity and trafficking of T-cells that are involved in numerous immuno-inflammatory diseases.

Equilliuim acquired rights to itolizumab via an exclusive partnership with BIOCON. It is marketed in India for chronic plaque psoriasis under the trade name ALZUMab. In July 2020, it received emergency use approval in India to treat cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe ARDS.

Based on the data and subsequent approval by the Drugs Controller General of India (DCGI), Equillium is planning a global controlled clinical trial of the drug in COVID-19 patients. It plans to file an Investigational New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) soon.

In the trial at four hospitals in India of 30 hospitalized COVID-19 patients, 20 received itolizumab and best supportive care, while 10 received best supportive care alone. The primary endpoint was mortality at one month.

In the patients receiving itolizumab, there were zero deaths and all patients have recovered. In the control arm, three patients died, and the rest have recovered. This mortality benefit was statistically significant. Patients receiving itolizumab demonstrated significant decreases in inflammatory cytokines such as IL-6 and TNFalpha.

“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanisms may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, co-founder and chief executive officer of Equillium. “We are working with Biocon to review its full dataset with the goal to move swiftly in determining appropriate next steps to accelerate further development of itolizumab to treat moderate to severely ill COVID-19 patients in the U.S. and abroad in the face of this global crisis.”

Biocon indicated plans to launch itolizumab for moderate to severe COVID-19 at a price of around Rs 8,000 per vial, or about $106.54 U.S.

“Until the vaccine comes, we certainly need lifesaving drugs,” said Kiran Mazumdar-Shaw, Biocon’s executive chairperson in a virtual press conference. “I think what we are doing across the world is to see how we can either repurpose drugs or develop new drugs to treat this pandemic.”

She added that even if a vaccine is available by the end of this year or early 2021, there is no guarantee there will not be reinfection, nor guarantees the vaccines will work the way we expect it to, so we need to be prepared.

“When Covid happened, we said it actually gives us a very strong case to try it (itolizumab) for Covid, because we do believe that the unique mechanism of action that it has can help us deal with this storm that we have seen is killing patients,” added Mazumdar-Shaw.

Mazumdar-Shaw indicated the company has manufacturing capacity and a supply and distribution network already in place, but now that the drug has received emergency use approval for COVID-19, “we are looking to ramp up production capacity to meet the expected surge in demand. Our aim is to reach a large number of patients across the country.”

Ivor S. Douglas, Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center, stated, “Patients with COVID-19 experience acute respiratory failure caused by the immune system flooding the bloodstream with inflammatory proteins, which can kill tissue, damage organs and pathologically activate clotting cascades in the lungs, heart, and kidneys. The novel mechanism of itolizumab, which works by inhibiting CD6 to reduce the activation and trafficking of pathogenic T-cells that release pro-inflammatory cytokines, may be well suited to address SARS-CoV-2 induced inflammation that drives respiratory failure in patients with COVID-19. The preliminary data as reported by Biocon is encouraging and highlights the urgent importance of further evaluating the potential therapeutic efficacy of itolizumab in treating patients diagnosed with COVID-19.”