Dova Pharma To Present Phase III Avatrombopag Data At The 2017 Liver Meeting Of The American Association For The Study Of Liver Diseases (AASLD)
Published: Oct 11, 2017
Detailed Safety and Efficacy Results from ADAPT-1 and ADAPT-2 Phase 3 Trials
to be Reported in Oral Presentation
Company to Host Investor and Analyst Conference Call and Webcast
at 5:00 p.m. on October 23rd
DURHAM, N.C., Oct. 10, 2017 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) today announced that Norah Terrault, M.D, M.P.H., Professor of Medicine at the University of California San Francisco, Division of Gastroenterology, will present the results from the avatrombopag Phase 3 clinical trials, ADAPT-1 and ADAPT-2, at the 2017 American Association for the Study of Liver Disease (AASLD) Meeting on Monday, October 23, 2017 at 3:00 p.m. EDT in Washington D.C. The presentation is scheduled from 3:00 p.m. to 3:15 p.m. EDT at the Walter E. Washington Convention Center in Room 207.
Avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA), is being developed for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. A New Drug Application (NDA) for avatrombopag was submitted to the U.S. Food and Drug Administration (FDA) on September 21, 2017. In both the ADAPT-1 and ADAPT-2 Phase 3 trials, avatrombopag met the primary and secondary efficacy endpoints with high statistical significance. Avatrombopag treatment was well tolerated with a safety profile that was generally comparable to that of placebo, with the frequency, severity, and types of adverse events reported being consistent with those expected in patients with CLD. Dr. Terrault will review the results of these pivotal Phase 3 clinical trials in detail at an oral presentation during the AASLD Liver Meeting.
Conference Call and Webcast
Dova will host an investor and analyst conference call and webcast, including slides, with Dr. Terrault at 5:00 p.m. EDT on October 23, 2017 to discuss the results. A question-and-answer session will follow the prepared remarks.
To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 97717584 five to 10 minutes before the start of the call.
A live webcast of the event will be available via the "Investor Relations" page of the Dova website, www.dova.com. A replay of the webcast will be archived on Dova's website for 90 days following the call.
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 immune thrombocytopenic purpura (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 now been submitted to 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 “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 regulatory development of avatrombopag. 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, 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 June 30th, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on August 14, 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.