Equillium has halted two clinical trials of its lead drug candidate out of an “abundance of caution” related to the coronavirus outbreak but continues to enroll in a third, which is evaluating the antibody as a treatment for acute graft-versus-host disease.
The decision made by the San Diego biotech, revealed in its annual report filed Thursday with regulators, is one of the latest examples of clinical trial progress being stymied by the deadly virus, which is delaying the development of some new drugs as companies struggle to cope with challenges including site closures, travel limitations, and supply chain interruptions.
In its filing, Equillium (NASDAQ: EQ) said the decision to pause trials studying the drug, itolizumab, as a treatment for uncontrolled asthma and for lupus nephritis was made “out of an abundance of caution related to the current global pandemic and our concern for the well-being of patients and their caregivers,” not because of any safety issues.
The company kicked off Phase 1b proof-of-concept clinical trials of itolizumab in patients with uncontrolled asthma and lupus nephritis in June and September, respectively.
The FDA has granted Equillium fast-track designation for itolizumab for the treatment of acute graft-versus-host disease (aGVHD) and orphan drug designation for prevention and treatment of aGVHD, a common complication following transplant procedures that can be life-threatening.
Inflammation from GVHD takes place when a donor’s cells view the healthy cells of the patient who received the transplant as foreign, and attack them. Some level of GVHD is anticipated with a transplant, and a range of medicines are used to control the condition.
In May 2019 the FDA approved an Incyte drug, ruxolitinib (Jakafi) a treatment for aGVHD in patients 12 years and older that doesn’t respond to the high dose systemic corticosteroids often used to suppress the dangerous immune system response—the first approved treatment for steroid-refractory aGVHD.
Equillium’s Phase 1b/2 clinical trial of itolizumab in patients with aGVHD started in March 2019. The company decided to continue enrollment in the trial given the severity of the disease, and its “potentially life-saving treatment for these severely ill patients,” the company said in its filing. Preliminary results are still anticipated in the second half of this year.
SVB Leerink analyst Thomas Smith, in a research note, called the company’s decision to halt the asthma and lupus trials “prudent given the disproportionate risks these patients face due to COVID-19.” Itolizumab is designed to suppress the immune system, which could increase patients’ vulnerability. And asthma patients, in particular, are at risk given the respiratory symptoms associated with COVID-19 infection.
Equillium management indicated “significant support from clinical trial sites and investigators” for continued enrollment in the aGVHD trial given the few treatment options available to those patients, as well as the potentially life-threatening nature of the condition, Smith said.
Smith said the decision could indicate signs of efficacy observed among patients receiving itolizumab (the trial is open label).
“Without such signs, the potential benefits of keeping enrollment open may not otherwise outweigh the risks,” he wrote.
Launched three years ago, Equillium licensed the US and Canadian rights to itolizumab from India’s Biocon, the country’s largest biopharma company and a major producer of biosimilars. Itolizumab is approved and marketed in India by Biocon as ALZUMAb as a treatment for some cases of the skin condition plaque psoriasis. Read more about Equillium’s origins here.