Shares in biotech Equillium (EQ) have almost tripled in Monday’s pre-market trading after the company announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.
Equillium is currently developing itolizumab to treat severe autoimmune and inflammatory disorders. The stock is currently trading up 260% in the pre-market.
Biocon also announced that the Drugs Controller General of India (DCGI) has granted restricted emergency use 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.
Based on the encouraging topline results and DCGI approval, Equillium revealed that it is now planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month.
As reported by Biocon:
- In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
- The mortality benefit observed in the itolizumab arm was statistically significant
- Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines
“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 immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, CEO of Equillium.
Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of pathogenic T cells that release pro-inflammatory cytokines in a range of autoimmune and inflammatory diseases. Equillium acquired rights to develop and commercialize itolizumab in the U.S., Canada, Australia and New Zealand through an exclusive collaboration and license agreement with Biocon.
Equillium is currently evaluating itolizumab under two open U.S. INDs for the treatment of acute graft-versus-host disease and lupus nephritis, as well as conducting a clinical study in uncontrolled asthma in Australia and New Zealand.
In March due to the emerging COVID-19 pandemic, Equillium announced that it was pausing enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Equillium has now announced that patient enrollment in both these studies has resumed.
Two analysts have recently published buy ratings on EQ. That’s with an average price target of $12. Stifel Nicolaus analyst Derek Archila reiterated his buy rating on the stock following the latest news.
“We note the trial in hospitalized COVID-19 patients was small (n=30), open-label and on top of standard of care, and little data were shared but according the Biocon/EQ press releases, the itolizumab arm did demonstrate a statistically significant benefit on mortality at one-month (the primary endpoint)” he told investors.
The current literature suggests approximately ~8% of COVID-19 patients develop ARDS and if itolizumab were to be priced in line with Gilead’s (GILD) remdesivir (~$2,500-$3,000 per course) this could be a meaningful market opportunity for EQ, Archila added. (See EQ stock analysis on TipRanks).
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