Dova Pharmaceuticals Announces Publication of Pivotal Phase 3 Data and Upcoming Congress Presentations for DOPTELET® (avatrombopag)

Dova Pharmaceuticals Announces Publication of Pivotal Phase 3 Data and Upcoming Congress Presentations for DOPTELET® (avatrombopag)

June 4, 2018

DURHAM, N.C., June 04, 2018 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) today announced the recent online publication of its pivotal Phase 3 trial data on the use of DOPTELET®  (avatrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) in the journal Gastroenterology (https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext); the final printed article, entitled “Avatrombopag before Procedures in Patients with Chronic Liver Disease and Thrombocytopenia: 2 Phase 3 Studies,” is to be published in the next four to six weeks.   In addition, the Company is today announcing multiple presentations for DOPTELET at several key global scientific congresses in June and July of this year.

DOPTELET is a second generation, once daily, orally administered TPO receptor agonist that was approved by the United States (US) Food and Drug Administration (FDA) on May 21, 2018 for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure.  

“We are very proud of the strong positive response of healthcare providers to the ADAPT trials safety and efficacy data as it has been shared at scientific advisory boards and key scientific congresses over the past year,” said Lee F. Allen, MD, PhD, Dova’s chief medical officer.  The quality and consistency of these data facilitated the FDA’s Priority Review and recent approval of DOPTELET for the treatment of thrombocytopenia in patients with CLD who are scheduled to undergo a procedure.  “Importantly, DOPTELET is the first orally administered TPO receptor agonist approved for this indication, which now provides healthcare providers with a new treatment option to facilitate the clinical management of these patients,” Dr. Allen said.  The Company plans to continue expanding the use of DOPTELET for other patients with thrombocytopenia by studying DOPTELET in additional clinical indications.”

The pivotal data publication and planned presentations will provide additional analyses that further highlight the consistent safety and efficacy data for DOPTELET from the two global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials, ADAPT-1 and ADAPT-2, that randomized over 430 patients and met all its primary and secondary endpoints.  In addition, these presentations include Phase 3 study data on the use of avatrombopag in the treatment of chronic immune thrombocytopenic purpura (ITP), and pharmacokinetic/pharmacodynamic (PK/PD) modeling data that supported Phase 3 dose selection and the effect of repeated dosing on platelet counts.

Four posters were accepted for presentation at the ongoing Digestive Disease Week (DDW) 2018 meeting that is being held June 2-5, 2018 in Washington D.C.  In addition, two posters are to be presented at the upcoming 23rdCongress of the European Hematology Association (EHA), which will be held from June 14-17, 2018 in Stockholm, Sweden.  Lastly, 4 posters will be presented at the 64thInternational Society on Thrombosis and Haemostasis (ISTH) Annual Scientific and Standardization Committee (SSC) Meeting, which will be held from July 18-21, 2018 in Dublin, Ireland.  

Details of the Scientific Presentations:

DDW Presentation Details:

Presentation Number: 1468Superiority of Avatrombopag to Placebo in Increasing Platelet Counts and Reducing Platelet Transfusions in Patients with Chronic Liver Disease-Associated Thrombocytopenia Undergoing Scheduled Procedures – Pooled Analysis of 2 Randomized Phase 3 Studies

  • Authors: Fred Poordad, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, and Naim Alkhouri                                                              

Presentation Number: 1475 Consistent Efficacy of Avatrombopag over Placebo in the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Invasive Procedures Across Demographic Subgroups – Pooled Results of Two Phase 3 Studies

  • Authors: Nancy Reau, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, Fred Poordad             

Presentation Number: 1548 Consistent Efficacy of Avatrombopag Compared to Placebo in Patients with Thrombocytopenia and Chronic Liver Disease Undergoing Procedures across Various Liver Disease Severities and Etiologies

  • Authors: Sammy Saab, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, Norah Terrault

Presentation Number: 1553 Efficacy of Avatrombopag Compared with Placebo across Various Mean Baseline Platelet Count Subgroups – Pooled Data from 2 Phase 3 Studies

  • Presenter: Sammy Saab, Naim Alkhouri, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, Wei Tian, Norah Terrault

EHA Presentation Details:

Presentation Number: PS1401 – Avatrombopag Demonstrates Superiority to Placebo for the Treatment of Chronic Immune Thrombocytopenic Purpura in a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial

  • Authors: Wojciech Jurczak, Krysztof Chojnowski, Jiri Mayer, Brian Jamieson, Wei Tian, Lee F Allen

Presentation Number: PF657 Superiority of Avatrombopag to Placebo in Reducing Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease Undergoing Scheduled Procedures - Pooled Analysis of 2 Studies

  • Authors: Fred Poordad, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, and Naim Alkhouri

ISTH Presentation Details:

Abstract PB022 - Superiority of Avatrombopag to Placebo in Increasing Platelet Counts and Reducing Platelet Transfusions in Patients with Chronic Liver Disease-associated Thrombocytopenia Undergoing Scheduled Procedures - Pooled Analysis of 2 Randomized Phase 3 Studies

  • Authors: Fred Poordad, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, and Naim Alkhouri

Abstract PB019 - PK Simulation of Avatrombopag-induced Increases in Platelet Counts with Redosing in Patients with Thrombocytopenia and Chronic Liver Disease

  • Authors: Siobhan Hayes, Colm Farrell, Kavita Aggarwal, Michael Vredenburg, Lee F Allen

Abstract PB024 - Population PK/PD Modeling of Avatrombopag in Patients with Thrombocytopenia and Chronic Liver Disease- Guided Phase 3 Dose Selection

  • Authors: Maiko Nomoto, Ziad Hussein, Kavita Aggarwal, Michael Vredenburg, Lee F Allen

Abstract PB020 - Exploratory Analyses of the Efficacy of Avatrombopag versus Placebo from 2 Phase 3 Studies Using Alternate Baseline Platelet Count Cohorts and an Alternate Secondary Efficacy Endpoint

  • Authors: Fred Poordad, Lee F. Allen, Kavita Aggarwal, Michael Vredenburg, Wei Tian, Norah Terrault

About DOPTELET

DOPTELET (avatrombopag) is a second generation, once daily, orally administered TPO receptor agonist recently approved for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. DOPTELET is designed to mimic the effects of TPO, the primary regulator of normal platelet production.

Two global Phase 3, double-blind, placebo-controlled trials (ADAPT-1 [N=231] and ADAPT-2 [N=204]), conducted in adults with thrombocytopenia (platelet count of less than 50,000/µL) and CLD, supported FDA approval.  Patients were assigned to either 40 mg or 60 mg of avatrombopag daily for 5 days based on their Baseline platelet counts (40 to <50,000/mL or <40,000/mL, respectively).  Avatrombopag was shown to be superior to placebo in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure in both trials in both the 40 mg (ADAPT-1, 88% vs. 38%, p <0.0001; ADAPT-2, 88% vs. 33%; p<0.0001), and 60 mg (ADAPT-1, 66% vs. 23%, p <0.0001; ADAPT-2, 69% vs. 35%; p=0.0006) treatment groups.  Avatrombopag was also superior to placebo at the two secondary efficacy endpoints in each trial.  In the avatrombopag treatment groups, there was an increased proportion of patients achieving the target platelet count of ≥50,000/mL on Procedure Day, and a greater magnitude of the change in mean platelet count from Baseline to Procedure Day; all treatment differences between the avatrombopag and placebo treatment groups were highly statistically significant with p values <0.0001.  The most common adverse reactions with avatrombopag included pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.  Portal vein thromboses have been reported in patients with CLD and in patients receiving TPO receptor agonists; one treatment-emergent event of portal vein thrombosis was reported in the two ADAPT trials in an avatrombopag-treated patient.

A marketing authorization application (MAA) is currently under review by the European Medicines Agency (EMA) for DOPTELET for the treatment of patients with thrombocytopenia and CLD scheduled to undergo a procedure, and the Company plans to submit a supplemental NDA to FDA for the treatment of chronic immune thrombocytopenia purpura (ITP) in the second half of 2018.  Work is also ongoing for the evaluation of DOPTELET in the treatment of chemotherapy-induced thrombocytopenia (CIT) and for the treatment of thrombocytopenia in patients undergoing more invasive surgical procedures.  Dova holds the worldwide intellectual property rights to avatrombopag for all current and future indications.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease.  Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists.  In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency). 

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS

Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

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 proprietary pipeline includes one commercial product, DOPTELET, for the treatment of thrombocytopenia in adult patients with CLD scheduled to undergo a procedure.

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 Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on February 16, 2018, 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

Mark W. Hahn
Chief Financial Officer
(919) 338-7936
mhahn@dova.com

Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com 

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Source: Dova Pharmaceuticals, Inc.