The drug that Equillium licensed from India-based pharma giant Biocon has received authorization for emergency use in that country in patients hospitalized with COVID-19.
The treatment, itolizumab, reduced mortality in a 30-person open-label randomized controlled trial in which the goal was to avoid or address a dangerous inflammatory response to the virus called cytokine release syndrome. Now La Jolla, CA-based Equillium (NASDAQ: [[ticker:EQ]]) plans to put itolizumab through its paces in the US, too.
The company’s stock has whipsawed this week, skyrocketing by 730 percent Monday to $26.50 apiece after Biocon announced the authorization from $3.19 per share on Friday, then plunging by nearly half to $13.98 per share Tuesday after Equillium filed paperwork detailing an agreement with an investment bank to potentially sell up to $150 million worth of its stock, a flexible offering known as a shelf registration.
Preliminary data from Biocon’s trial revealed that patients given the drug in addition to best supportive care were less likely to have died a month after receiving it than those who received best supportive care alone. Patients hospitalized with COVID-19 who were enrolled in the study, which took place at four hospitals in India, were fighting moderate-to-severe levels of fluid buildup in their lungs, a condition known as acute respiratory distress syndrome (ARDS).
Biocon reported that all of the patients who received itolizumab recovered, while three in the control arm died. The mortality benefit observed was statistically significant, or unlikely to have occurred due to chance, according to the company. These results prompted the Drugs Controller General of India to green-light itolizumab’s emergency use to treat patients with COVID-19, the world’s first such authorization for a biologic drug.
Patients in the itolizumab group saw reductions in the levels of certain inflammatory proteins, such as IL-6 and tumor necrosis factor-alpha, in their bloodstreams, Biocon said. That’s important because scientists believe that for some patients who die after contracting the virus, a contributing factor is an overaggressive inflammatory response known as a cytokine storm in which the body attacks its own cells. Proteins that attempt to fight the infection end up instead killing tissue and damaging organs; itolizumab works by ramping down the activity of certain T cells that prompt these cytokines to action.
Now Equillium, which was formed in 2017 to advance the development of itolizumab after it licensed rights to the compound from Biocon, plans to ask the FDA to give it the go-ahead to conduct a randomized controlled trial of the drug in COVID-19 patients in the US and other countries where the infection is rampant.
“We and Biocon feel an enormous sense of urgency around this given the unmet need, and the results that Biocon have released are very encouraging,” company co-founder and CEO Bruce Steel (pictured) said in an interview. “We want to try and follow it up as fast as we can.”
Equillium is working with Biocon to analyze the full dataset from the study, preparing to meet with the FDA, and determining how best to fund the work, he said. As of the end of the first quarter the company reported about $47.6 million in cash, cash equivalents, and short-term investments on hand. Before it added a COVID-19 trial to its plate, that money was expected to carry it through the second half of 2021.
“Obviously if we are ramping up on a COVID study, depending upon the size of that study and where it’s conducted and so forth, that will clearly be utilizing cash,” Steel said.
On Tuesday it announced the shelf registration offering, which sets it up to quickly issue stock on a staggered basis if it decides to. But Steel says he anticipates sources such as the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA), which have been doling out non-dilutive funding to companies that are working on potential COVID-19 treatments, may be interested in backing its work given the Biocon data—and its large-scale commercial manufacturing capabilities. Biocon already markets itolizumab in India under the name ALZUMab for the treatment of chronic plaque psoriasis.
“You want to be able to not only run a study but you want to be able to get product to patients quickly, so we’re very fortunate that Biocon is a global manufacturer of biologics already, and they’ve already basically completed the scale-up manufacturing of itolizumab,” Steel said.
Equillium has the rights to develop the drug in the US, Canada, Australia, and New Zealand. Currently the company is evaluating itolizumab as a potential treatment for acute graft-versus-host disease (aGVHD) and lupus nephritis, as well as in Australia and New Zealand in patients with uncontrolled asthma. In March, the company paused enrollment in the asthma and lupus nephritis trials as a result of disruption caused by COVID-19; the aGVHD trial wasn’t interrupted. On Monday Equillium announced the trials have since resumed.
Image: iStock/Naeblys
