RIGL stock is up 19% in after-hours trading on August 4, 2020, after the company reported earnings and revenue beats.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the second quarter ended June 30, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Rigel Pharmaceuticals reported Q2 EPS of (10c) versus the consensus estimate of (13c). The company reported Q2 revenue of $16M versus the consensus estimate of $13.75M.
“During the second quarter we achieved significant progress across all aspects of our business, despite the challenges resulting from the COVID-19 pandemic,” said Raul Rodriguez, Rigel’s president and CEO. “Sales of TAVALISSE increased during the quarter and in July, the product became available in initial European markets. We continued to advance our pipeline, most recently with the launch of an investigator-sponsored trial in COVID-19 pneumonia. We believe there is clear scientific rationale to explore the potential of SYK-inhibition to treat these patients and possibly prevent severe respiratory conditions resulting from COVID-19. We will continue to pursue opportunities to expand these efforts.”
Rigel announced a Phase 2 investigator-sponsored trial (IST) with Imperial College London to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia. The IST is a two-stage, open label, controlled clinical trial with patients randomized (1:1:1) to fostamatinib, ruxolitinib, or standard of care. Treatment will be administered twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel will provide support for this trial along with Novartis.
Recent in vitro studies led by the Amsterdam University Medical Center at the University of Amsterdam, showed that R406, the active metabolite of fostamatinib, blocked macrophage hyperinflammatory responses to a combination of immune complexes formed by anti-Spike IgG in serum from severe COVID-19 patients. Anti-Spike IgG levels are known to correlate with the severity of COVID-19. These results suggest that by inhibiting anti-Spike IgG-mediated hyperinflammation, R406 could potentially play a role in the prevention of cytokine storms as well as pulmonary edema and thrombosis associated with severe COVID-19.1
In addition, researchers at The Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard led a recent screen to identify FDA-approved compounds that reduce mucin-1 (MUC1) protein abundance. MUC1 is a biomarker used to predict the development of ALI and ARDS and correlates with poor clinical outcomes. Of the 3,713 compounds that were screened, fostamatinib was the only compound identified which both decreased expression of MUC1 and is FDA approved. Fostamatinib demonstrated preferential depletion of MUC1 from epithelial cells without affecting cell viability. The research was focused on drug repurposing for the much lower risk of toxicity and the ability of FDA-approved treatments to be delivered on a shortened timescale, which is critical for patients afflicted with lung disease resulting from COVID-19.2
Post-hoc data analysis from Rigel’s previous Phase 3 clinical program of TAVALISSE in adult patients with chronic ITP, which highlights the potential benefit of use in earlier lines of therapy, was published in the British Journal of Haematology. Inclusion in one of the leading peer-reviewed journals in the field of hematology underscores the significance of the 78% (25/32) response rate, defined as at least 1 platelet count of at least 50,000/µL, when TAVALISSE was used as a second-line therapy in Rigel’s Phase 3 clinical program. Adverse events were manageable and consistent with those previously reported with fostamatinib. Rigel’s field teams are sharing this analysis with physicians.
Grifols S.A., Rigel’s collaborator in Europe, launched fostamatinib disodium hexahydrate in Germany and the United Kingdom in July, under the European brand name TAVLESSE. TAVLESSE is indicated in Europe for the treatment of chronic ITP in adult patients who are refractory to other treatments.
Clinical trial sites in Rigel’s FORWARD study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (wAIHA), are now mostly open and enrolling patients after a temporary postponement due to the COVID-19 pandemic. Currently, the FORWARD study has enrolled 44 of the 90 patients targeted for enrollment and has over 90 active clinical trial sites established across 22 countries with incremental sites being added.
At the European League Against Rheumatism (EULAR) 2020 E-Congress in June, Rigel presented two oral and two poster presentations highlighting its investigational compound R835, a potent and selective inhibitor of both interleukin receptor associated kinase (IRAK)1 and IRAK4. In multiple pre-clinical rodent models of acute and chronic inflammation, R835 administration resulted in reduced inflammation, and in Phase 1 human studies it showed encouraging pharmacokinetic properties.
Rigel has appointed Dave Santos as executive vice president and chief commercial officer. Mr. Santos joins Rigel with over 30 years of commercial experience in the biopharmaceutical industry with companies such as Bristol-Myers Squibb, Lilly, Genentech, and most recently Jazz Pharmaceuticals, where he led the Hematology/Oncology Business Unit. He has a robust track record in sales and marketing leadership roles, building commercial capabilities, and growing brands in the hematology-oncology area, where he has spent most of his career.