Shares of La Jolla, California-based Equillium (NASDAQ:EQ) exploded 730% on July 13th after the biotechnology company announced positive COVID-19 data from a clinical trial of itolizumab. The topline results showed the drug candidate reduced mortality in patients hospitalized with COVID-19 in a trial conducted by Indian biopharmaceutical company Biocon Limited.
As a result, Biocon received restricted emergency use approval of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India. The approval came from the Drugs Controller General of India, the regulatory agency that oversees drug approvals in the country.
Meanwhile Equillium is planning to conduct a global clinical trial of itolizumab in COVID-19 patients upon filing a U.S. investigational new drug (IND) application.
The company has been developing its core itolizumab product candidate as a general treatment for severe autoimmune and inflammatory disorders.
No deaths reported in patients that received itolizumab
The open-label study took place at four different hospitals in India and enrolled 30 COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab and “best supportive care” while the other ten patients received solely best supportive care.
After one month, no deaths were reported in the itolizumab arm of the study and all patients recovered from COVID-19. In the control arm of patients who did not receive the treatment, three deaths occurred, and the rest of the patients recovered.
The statistically significant result met the study’s primary endpoint regarding mortality. Moreover, patients who received itolizumab also experienced significantly lower counts of inflammatory cytokines, small proteins released by human cells that act as immunomodulating agents.
Equillium Co-founder and CEO Bruce Steel stated, “The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immune-inflammatory complications experienced by COVID-19 patients.”
Itolizumab is an antibody therapy that inhibits the activity of pathogenic T cells that release pro-inflammatory cytokines in various autoimmune diseases.
In the days ahead Equillium will be collaborating with Biocon on a complete review of the dataset. The company plans to move expeditiously to further develop the drug candidate as a treatment for moderate to severely ill COVID-19 patients around the world.
Equillium previously attained the rights to develop and commercial itolizumab in the U.S., Canada, Australia, and New Zealand through a partnership and licensing agreement with Biocon. The drug is also being evaluated in the U.S. under a pair of open INDs as a potential treatment for acute graft-versus-host disease (GVHD) and lupus nephritis. The therapeutic is additionally involved in a clinical study of uncontrolled asthma in Australia and New Zealand.
Biocon has already received approval of itolizumab as a plaque psoriasis treatment in India and manufactures the drug at a bio-manufacturing facility that is regulated by the U.S. Food & Drug Administration (FDA).
Although the trial of itolizumab in COVID-19 patients was small in term of sample size, the results were big. They suggest Equillium may have a significant growth opportunity ahead if it can continue to receive regulatory approvals outside of the emergency use approval granted in India.