DURHAM, N.C., Dec. 04, 2017 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) today announced that the Company will present four abstracts, three of which will be oral presentations, with data from Phase 3 clinical trials of avatrombopag in patients with chronic liver disease (CLD) and immune thrombocytopenic purpura (ITP) at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held December 9-12, 2017 in Atlanta, Georgia. In addition to data on the safety and efficacy of avatrombopag, data are also being presented at the meeting on platelet function in patients with CLD treated with avatrombopag and placebo.
Avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA), has been developed for the treatment of thrombocytopenia in patients with CLD who are scheduled to undergo a procedure. Dova has submitted a New Drug Application (NDA) for avatrombopag to the United States Food and Drug Administration (FDA), which was based on two identically-designed Phase 3 clinical trials, ADAPT 1 and ADAPT 2, in which avatrombopag met all primary and secondary endpoints with high statistical significance. The NDA was accepted for filing and has been granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.
Details for ASH presentations are as follows:
Title: Avatrombopag, a Novel Oral Thrombopoietin Receptor Agonist, Demonstrates Superiority to Placebo for the Treatment of Chronic Immune Thrombocytopenic Purpura in a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- Session: 311. Disorders of Platelet Number or Function: ITP: clinical aspects
- Abstract Number: 17
- Presentation Type: Oral
- Date and Time: Saturday, December 9, 2017: 8:30 AM
- Location: Georgia World Congress Center: Bldg B, Lvl 3, B304-B305
- Presenter: Wokciech Jurczak, Department of Hematology, UJ CM, Krakow, Poland
Title: Superiority of Avatrombopag to Placebo in Increasing Platelet Counts in Patients with Chronic Liver Disease-Associated Thrombocytopenia Undergoing Scheduled Procedures: Results from 2, Phase 3 Randomized Studies
- Session: 311. Disorders of Platelet Number or Function: ITP: clinical aspects
- Abstract Number: 18
- Presentation Type: Oral
- Date and Time: Saturday, December 9, 2017: 8:45 AM
- Location: Georgia World Congress Center: Bldg B, Lvl 3, B304-B305
- Presenter: Norah Terrault, MD, MPH, University of California San Francisco, San Francisco, CA
Title: Avatrombopag, a Novel Thrombopoietin Receptor Agonist, Increases Platelet Counts without Increasing Platelet Activation in Patients with Thrombocytopenia Due to Chronic Liver Disease
- Session: 311. Disorders of Platelet Number or Function: Poster II
- Abstract Number: 290
- Presentation Type: Oral
- Date and Time: Sunday, December 10, 2017: 7:45 AM
- Location: Georgia World Congress Center: Bldg B, Lvl 2, B216-B217
- Presenter: Andrew L Frelinger III, PhD, Center for Platelet Research Studies, Harvard Medical School, Boston, MA
Title: Platelet Function in Thrombocytopenic Patients with Chronic Liver Disease
- Session: 311. Disorders of Platelet Number or Function: Poster II
- Abstract Number: 2314
- Presentation Type: Poster
- Date and Time: Sunday, December 10, 2017: 6:00 – 8:00 PM
- Location: Georgia World Congress Center: Bldg A, Lvl 1, Hall A2
- Presenter: Elena Smolensky Koganov, PhD, Center for Platelet Research Studies, Harvard Medical School, Boston, MA
About Avatrombopag
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. Avatrombopag is initially being studied for its potential for the acute treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure. Dova is also planning to explore the potential use of avatrombopag in a broader population of patients with thrombocytopenia, including in patients undergoing surgical procedures associated with a high risk of bleeding, and patients who develop thrombocytopenia after receiving chemotherapy. In addition, Dova is exploring a potential regulatory approval pathway for avatrombopag for the treatment of adults with chronic ITP based on results from a completed Phase 3 trial in this patient population. 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 submitted to the FDA for this initial indication.
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 and the clinical development of avatrombopag for other indications. 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.
Contacts
Doug Blankenship
(919) 748-5975
dblankenship@dova.com
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com