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Development Strategy Updates for Dova Pharmaceuticals
DURHAM, N.C.—After two meetings with the FDA, Dova Pharmaceuticals, Inc. has plans for the second half of 2018: to submit a Supplemental New Drug Application (sNDA) for the treatment of patients with immune thrombocytopenic purpura (ITP), and to initiate a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT). Results from the previously completed Phase 3 ITP clinical trial were recently presented on December 10, 2017 at the American Society of Hematology (ASH) meeting.
Dr. David Kuter, Director of Clinical Hematology at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School said, “Having been involved in the development of avatrombopag for the past eleven years, I am excited to see the continued development of this important compound. CIT restricts our ability to maintain clinically effective doses and can delay the start of cycles of chemotherapy. Avatrombopag has the potential to allow us to maintain both the planned doses of chemotherapy and the schedule of administration. For patients with ITP, avatrombopag may offer important advantages over existing treatment options given its potency while at the same time lacking hepatotoxicity as well as drug absorption issues seen with other oral TPO-RA agents.”
To date, avatrombopag has completed one Phase 3 clinical trial and two Phase 2 clinical trials evaluating the use of avatrombopag for the treatment of adults with chronic ITP. In the Phase 3 trial, the primary efficacy endpoint was achieved with high statistical significance (p<0.0001).
Based on these results and recent discussions with the FDA, Dova anticipates submitting a sNDA for avatrombopag in the second half of 2018, and plans a Phase 3 clinical trial to evaluate avatrombopag for the treatment of patients with CIT. This randomized, double-blind, placebo-controlled trial is expected to enroll subjects who develop Grade 3/4 thrombocytopenia following a previous cycle of chemotherapy. The primary objective of the study is to evaluate the efficacy of avatrombopag in increasing platelet counts and therefore preventing the need for a platelet transfusion, chemotherapy dose reduction, or chemotherapy cycle delay.
Leerink Partners analysts Geoffrey C. Porges and Bradley Canino, say that “because the company is committed to running a phase III trial [for CIT], which is presumably designed and powered with FDA input, we see the likelihood of regulatory success as higher in this indication than in ITP. The lack of long-term safety on maintenance therapy should not be an issue for this indication either, with cumulative exposure to chemotherapy dose likely a viable regulatory endpoint for this indication. As a result of these factors, we believe the real incremental revenue opportunity from this update is the CIT indication.
“[W]e do not believe a green light from the FDA to file a sNDA indicates a high likelihood of success for the chronic ITP filing, nor of the commercial potential in ITP. We remain cautious about the likelihood of regulatory success and about the commercial profile and potential in this indication. However, the CIT indication is more promising, and once we see the clinical trial design, endpoints and development timeline, we expect to conduct further research to assess the value of this indication in our forecast and valuation for Dova.”