CAMBRIDGE, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- Anthos Therapeutics, Inc. (Anthos), is a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today announced the appointment of Bill Meury as CEO and member of the board of directors. Meury joins after successfully leading Karuna Therapeutics (Karuna), which was recently acquired by Bristol Myers Squibb (BMS).
During his time at Karuna, Meury led the company through a period of rapid expansion, and a transition to a fully integrated R&D and commercial organization. Meury will succeed founding CEO John Glasspool, who will join Blackstone Life Sciences as an Operating Advisor.
Nicholas Galakatos, Ph.D., Chairman of the Board of Directors of Anthos, and Global Head of Blackstone Life Sciences, said: “Bill is a proven leader with a strong track record of advancing innovative medicines through to approval and to patients globally. We are confident that he and the Anthos team will rapidly advance the development of abelacimab to help benefit the many patients who are in need of a safer type of anticoagulant. We are also grateful for John’s many contributions in getting abelacimab to achieve impressive clinical development success.”
Bill Meury, incoming Anthos CEO, said: “With the highly novel Factor XI inhibitor, abelacimab, as the lead product, Anthos has quickly emerged as one of the most innovative companies in the biotech sector. The opportunity to further build Anthos with Blackstone’s scale capital and potentially make a significant impact for patients with atrial fibrillation, cancer associated thrombosis and perhaps other therapeutic indications, where abelacimab may prove to be advantageous, is extremely motivating. I look forward to working with the talented team and forming new relationships with all the stakeholders who have put in so much effort to date. Abelacimab has the potential to be a game-changing treatment for patients.”
Paris Panayiotopoulos, Anthos Board Member and Senior Managing Director of Blackstone Life Sciences, said: “I am very excited that Bill has agreed to join Anthos as its next CEO. Our Board is confident that Bill’s experience, including serving as CEO of Karuna prior to its merger to BMS for $14 billion and as Chief Commercial Officer of Allergan, where he led 8,000 people prior to its merger with AbbVie, will be invaluable in bringing Anthos’ potential blockbuster treatment to all patients who live with the daily fear of bleeding while taking current anticoagulants.”
Prior to Karuna, Meury served as the Chief Commercial Officer for Allergan from 2015-2020 and has led multiple divisions within global pharmaceutical companies around the world, including marketing, sales, business analytics, marketing operations, managed care, pricing, and customer service. Previously, Meury also served as President, Branded Pharmaceuticals for Actavis, and Executive Vice President, Sales and Marketing, Forest Laboratories. He received a B.S. in economics from the University of Maryland.
About Anthos Therapeutics
Anthos Therapeutics was founded by Blackstone Life Sciences in 2019 and obtained from Novartis Pharma AG the exclusive global rights to develop, manufacture, and commercialize abelacimab. Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for high-risk cardiovascular patients.
For more information, visit the Company’s website and follow on Twitter and LinkedIn.
About Abelacimab
Abelacimab is a novel, dual-acting, once-monthly-administered fully human monoclonal antibody that binds to FXI preventing its activation and also neutralizing FXIa activity.[i]
As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status.
Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.[ii] Abelacimab is the only Factor XI inhibitor being studied for both conditions.
In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration.
In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.[ii] In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.[iii] In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.[iv]
Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Abelacimab is an investigational agent and is not approved for any indication in any country.
About the Abelacimab Atrial Fibrillation (AF) Program
About the AZALEA-TIMI 71 Phase 2 Study
The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily.
With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant.
Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:[v]
- Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P<0.001, HR 0.33, 95% Cl 0.19–0.55)
- 74% reduction in major bleeding alone with abelacimab 150 mg vs rivaroxaban 20 mg (P=0.002, HR 0.26, 95% CI 0.11-0.61)
- 93% reduction in gastrointestinal (GI) bleeding with abelacimab 150 mg vs rivaroxaban 20 mg (P=0.008, HR 0.07, 95% Cl 0.01-0.50)
- 51% reduction in net clinical outcome with abelacimab 150 mg vs rivaroxaban 20 mg (P<0.001, HR 0.49, 95% CI 0.33-0.71)
- Factor XI inhibition of ~99% with abelacimab 150 mg dosed once monthly
The AZALEA-TIMI 71 study enrolled 1,287 patients across 95 global study sites including the U.S. and Canada, Europe and Asia. The independent data monitoring committee (IDMC) recommended that the study end early because of a substantially greater than anticipated reduction in major and clinically relevant non-major bleeding in the abelacimab arms compared to rivaroxaban and a benefit:risk ratio that favored abelacimab. At the same time, the IDMC also recommend that an optional open-label extension period should be made available.
AZALEA-TIMI 71 Open-Label Extension
An optional extension period in order to provide longer-term data was included as part of the AZALEA-TIMI 71 study protocol. It could be initiated if the independent data monitoring committee (IDMC) stopped the study early due to an imbalance of bleeding substantially favoring abelacimab over rivaroxaban, and the benefit:risk clearly favored abelacimab. Investigative sites had the option of participating or not participating in the extension period. Patients who completed the end-of-treatment visit on study treatment and met the eligibility criteria for the extension period had the option to participate or not.
About the LILAC-TIMI 76 Phase 3 Study
The LILAC-TIMI 76 study is an event-driven, randomized, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation (AF) who have been deemed to be unsuitable for currently available anticoagulation therapy. Patients in the study will be randomized to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly. The study is targeting to enroll approximately 1,900 patients from more than 400 sites in North America, Europe, Latin America, the Middle East and Asia.
About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)
The abelacimab Phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2,700 patients across 220 sites in more than 23 countries -- the largest program of any anticoagulant performed in cancer-associated thrombosis. Abelacimab received FDA Fast-Track designation for the treatment of thrombosis associated with cancer in July 2022.
MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, Phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months. Recruitment for this trial began in August 2022.
ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, Phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the initiation, and timing, of future clinical trials and its research and development. All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
Media Contact:
Caren Begun
TellMed Strategies
908-947-0500 x723
caren.begun@tmstrat.com
[i] David Gailani, Andras Gruber. Blood 2024 (https://ashpublications.org/blood/article-abstract/143/15/1465/506712/Targeting-factor-XI-and-factor-XIa-to-prevent?redirectedFrom=fulltext)
[ii] Hsu et al. J Am Coll Cardiol. Aug. 2021 (https://www.sciencedirect.com/science/article/abs/pii/S0735109721053213?via%3Dihub)
[iii] Yi BA et al. J Thromb Haemost. Oct. 2021 (https://pubmed.ncbi.nlm.nih.gov/34714969/)
[iv] Verhamme P et al. New Engl J Med July 2021 (https://www.nejm.org/doi/full/10.1056/NEJMoa2105872)
[v] TIMI Study Group website; AZALEA-TIMI 71 page (https://timi.org/azalea-timi-71/)
