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.
The study will be conducted at multiple sites in the
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.
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.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. SEMDEXA announced highly statistically significant positive top-line results from its Phase III Pivotal Trial C.L.E.A.R Program for its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica). ZTlido® was approved by the FDA on
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Source: Sorrento Therapeutics, Inc.