Rigel Pharmaceuticals, Inc. RIGL announced that a phase II study has been initiated to evaluate its oral spleen tyrosine kinase (“SYK”) inhibitor drug, Tavalisse (fostamatinib), as a potential treatment for hospitalized COVID-19 patients. The study is being sponsored by the National Heart, Lung and Blood Institute (“NHLBI”), part of the National Institutes of Health (“NIH”). The study is conducted in collaboration with Inova Health System, a non-profit health organization.
The phase II study will evaluate the safety of Tavalisse as its primary endpoint in 60 patients who will either receive the drug twice daily or a matching placebo for 14 days, followed by a follow-up period of 60 days. The study will enroll COVID-19 patients with a score of 5 to 7 on the 8-point ordinal scale. Patients will be primarily in the critical stage as they may require supplemental oxygen via nasal canula or non-invasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation. Secondary objectives of the study include the assessment of early efficacy and clinically relevant measures of disease progression.
Shares of Rigel Pharmaceuticals have gained 21.4% so far this year against the industry’s decline of 6.6%.
Rigel Pharmaceuticals believes that the SYK inhibition characteristics of Tavalisse may lead to decreased thromboinflammation and in turn help alleviate organ dysfunction in critically ill patients with COVID-19. Moreover, data from a study led by the Amsterdam University Medical Center at the University of Amsterdam have shown that hyperinflammatory response by human macrophages is induced by anti-Spike IgG from the serum of severely ill COVID-19 patients. The company believes that this hyperinflammatory response can be counteracted by SYK inhibition with Tavalisse.
Meanwhile, the company is evaluating the drug in another phase II study as a potential treatment of COVID-19 pneumonia. The study is being conducted by Imperial College London and evaluating the efficacy of Tavalisse versus standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. The study is also evaluating another drug, Incyte INCY/ Novartis’ NVS JAK inhibitor, Jakavi/Jakafi.
Please note that Tavalisse is currently approved as a treatment for adults with chronic immune thrombocytopenia, who are refractory to other therapies. The company is also developing the drug as a potential treatment for warm autoimmune hemolytic anemia. The drug has generated sales of $27.7 million in the first half of 2020, reflecting growth of 52% year over year. A successful development as a treatment for COVID-19 is likely to lead to higher revenues from the drug amid thousands of COVID-19-infected patients in serious or critical stage.
Meanwhile, several pharma companies are developing treatments/antibodies for different stages of COVID-19. Leading among them is Gilead’s GILD Veklury (remdisivir), which has already received an emergency use authorization from the FDA for treating all hospitalized patients with COVID-19. Lilly and Incyte’s rheumatoid arthritis drug, Olumiant, in combination with remdesivir met a phase III study’s primary endpoint evaluating the combination in hospitalized patients with COVID-19 infections. Other players developing a treatment for COVID-19 include OPKO Health, Vanda Pharmaceuticals, Roche and Amgen.
Zacks Rank
Rigel Pharmaceuticals currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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