Supplemental NDA for ITP to be submitted in the second half of 2018
Phase 3 Clinical Trial for CIT to begin in the second quarter of 2018
DURHAM, N.C., Jan. 03, 2018 (GLOBE NEWSWIRE) -- Following two separate meetings with the U.S. Food and Drug Administration (FDA), Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) plans to submit a Supplemental New Drug Application (sNDA) in the second half of 2018 for the treatment of patients with immune thrombocytopenic purpura (ITP) and initiate a Phase 3 clinical trial in the second quarter of 2018 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.
Immune Thrombocytopenic Purpura (ITP)
ITP is a disorder that occurs when the immune system mistakenly produces antibodies against platelets resulting in thrombocytopenia and an increased risk of bleeding. Chronic ITP, which affects approximately 60,000 adults in the United States, is when the disorder has persisted for more than 12 months. Thrombopoietin receptor agonists (TPO-RAs) are commonly used when patients with chronic ITP have had an inadequate response to first line therapies such as corticosteroids and immunoglobulins. The current global market size for the TPO-RAs is $1.2 billion.
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 FDA, Dova anticipates submitting a sNDA for avatrombopag in the second half of 2018.
Chemotherapy-induced thrombocytopenia (CIT)
CIT is a common complication in cancer patients undergoing chemotherapy for the treatment of various solid tumors (e.g., ovarian, breast). CIT, which can occur in up to 70% of cancer patients receiving certain chemotherapy regimens, not only increases the risk of bleeding, but may also necessitate a reduction in either chemotherapy dose or cycles. Unfortunately, such reductions can compromise the effectiveness of chemotherapy and lead to sub-optimal outcomes for cancer patients. In the United States, there are approximately 125,000 platelet transfusions every year for cancer patients who develop CIT.
Dova intends to initiate 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.
Dr. David Kuter, Director of Clinical Hematology at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School commented, “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.”
Avatrombopag is a second generation orally administered TPO-RA which is intended to address the limitations of other existing treatments for thrombocytopenia. In two identically-designed Phase 3 clinical trials, ADAPT 1 and ADAPT 2, avatrombopag met all primary and secondary endpoints with high statistical significance. The New Drug Application (NDA) for treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure has been accepted for priority review by FDA with a PDUFA date of May 21, 2018. Dova holds the worldwide rights to avatrombopag for all current and future indications.
About Dova Pharmaceuticals, Inc.
Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure, and an NDA has been accepted for priority review by FDA for this initial indication with a PDUFA date of May 21, 2018.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipated”, “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Dova’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential U.S. launch for avatrombopag in patients with CLD who are scheduled to undergo a procedure, the submission of a sNDA in the second half of 2018 for the treatment of patients with ITP, and the initiation of a Phase 3 clinical trial in the second quarter of 2018 for the treatment of patients with CIT. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, increased regulatory requirements, Dova’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Dova’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on November 9, 2017, and Dova’s other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Dova as of the date of this release, and Dova assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.