SORRENTO REPORTS FDA CLEARANCE FOR THE COMMENCEMENT OF A PHASE 2/3 STUDY FOR ABIVERTINIB IN TREATMENT OF HOSPITALIZED PATIENTS WITH SEVERE PNEUMONIA DUE TO COVID-19
Abivertinib is a novel oral small molecule tyrosine kinase inhibitor that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) as well as Bruton's tyrosine kinase (BTK) and potentially can reduce cytokine storm associated with acute respiratory distress syndrome (ARDS) in severe hospitalized COVID-19 patients.
Sorrento will be starting a multicenter, multinational Phase 3 study with a Phase 2 run-in to identify the recommended Phase 3 dose (RP3D) and to demonstrate the safety and efficacy of Abivertinib in patients with respiratory compromise due to COVID-19.
This clearance follows the successful completion of parallel phase 2 studies in the US and Brazil, both of which indicated that a high-risk population of patients requiring oxygen support by non-invasive ventilation or high flow oxygen appeared to be more likely to benefit from Abivertinib therapy than those receiving low flow oxygen in reducing progression of respiratory failure.
SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), announced today that the FDA has given clearance for Sorrento to commence the Phase 3 clinical trial of Abivertinib in severe COVID-19 patients (hospitalized patients with respiratory compromise requiring oxygen supplementation). The clinical trial will be conducted in 2 phases, and the initial run-in will define the RP3D. In October 2021, Sorrento released preliminary results of two phase 2 studies that seemed to show that patients hospitalized with severe pneumonia due to COVID-19, especially those requiring non-invasive ventilation or high flow oxygen supplementation, were up to 5-fold more likely to benefit from Abivertinib therapy than those patients who required low flow supplementation. Such patients represent a high-risk population with few treatment options.
The study will be conducted at multiple sites in the USA, Mexico and Brazil. “We are encouraged by the results from our Phase 2 study, and excited to move Abivertinib to the next stage to help these patients who have no good alternatives,” said Dr. Henry Ji, Chairman and CEO of Sorrento.
Sorrento believes the availability of an oral dosage form to manage inflammatory disease progression is very relevant for severely afflicted patients with COVID-19-induced respiratory failure and potentially non-COVID acute respiratory distress syndrome (ARDS). This treatment has the potential to provide significant benefits across the globe with respect to logistical access, scalability and affordability by potentially providing a treatment in a convenient oral dosage form. Sorrento intends to explore the administration of Abivertinib for severe non-COVID related pneumonia and ARDS patients, as the mechanism of disease progression is very similar and the current medical options for treatment are limited.
About Abivertinib
Abivertinib is a novel dual target, small molecule tyrosine kinase inhibitor (TKI) designed to selectively target mutant forms of the epidermal growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK).
Abivertinib is a third generation EGFR inhibitor that irreversibly targets mutant forms of EGFR in advanced non-small cell lung cancer (NSCLC) patients resistant to first-line EGFR kinase inhibitor therapies with comparable efficacy and safety. Abivertinib demonstrated different resistant mechanisms with rare occurrence of acquired resistant mutation, C797S and potential inhibition of Osimertinib (Tagrisso) resistant tumors in PDX models.
Abivertinib also irreversibly binds to the BTK receptor, inhibiting the phosphorylation of the receptor required for malignant cell survival such as B lymphocytes and prostate cancer.
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