CFO Jonathan Cartu Says - GBT Announces Upcoming Virtual Data Presentations at 62nd America... - Jonathan Cartu Family Medical Clinic & Patient Care Center
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CFO Jonathan Cartu Says – GBT Announces Upcoming Virtual Data Presentations at 62nd America…

GBT Announces Upcoming Virtual Data Presentations at 62nd America...

CFO Jonathan Cartu Says – GBT Announces Upcoming Virtual Data Presentations at 62nd America…


Abstracts Include 72-Week Analysis of Phase 3 HOPE Study Supporting Long-Term Use of Oxbryta® (voxelotor)

Preclinical Data Highlights Promise of GBTs Sickle Cell Disease Pipeline

GBT to Host Virtual Analyst & Investor Day Event on Monday, Dec. 7, 2020

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), today announced that nine abstracts related to its sickle cell disease (SCD) programs will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, taking place online Dec. 5-8, 2020. The studies to be presented include the 72-week analysis of the Phase 3 HOPE Study of Oxbryta® (voxelotor) tablets and new research from GBT’s pipeline.

“Nearly one year after the FDA approval of Oxbryta, we are pleased to share new clinical data supporting both the long-term use of this first-in-class therapy to reduce anemia and hemolysis in people with sickle cell disease and its effectiveness in the real-world setting,” said Ted W. Love, M.D., president and chief executive officer of GBT. “As part of our strategy to be the leader in sickle cell disease and our deep commitment to this community, we are also excited to unveil new preclinical data from our SCD pipeline programs, including our novel fully human monoclonal antibody that has the potential to be a best-in-class P-selectin inhibitor, and our next generation hemoglobin S polymerization inhibitor.”

Highlights of the data to be presented at ASH include:

Oxbryta

  • An analysis of the Phase 3 HOPE Study showed that Oxbryta (1,500 mg) treatment demonstrated sustained improvements in hemoglobin (Hb) levels and markers of hemolysis over 72 weeks, consistent with previously published 24-week analyses. These results support durability of Oxbryta longer-term use to reduce anemia and hemolysis and potentially mitigate the associated morbidity and mortality of SCD.
  • Consistent with the 24-week results analysis, patients in the Phase 3 HOPE Study who achieved the greatest average Hb levels over 72 weeks with Oxbryta experienced numerically fewer vaso-occlusive crises (VOCs), with a stepwise reduction in VOC rate with each increase in Hb stratum (up to 12 to ≤ 13.3 g/dL).
  • In the Phase 3 HOPE Study, the Clinical Global Impression of Change (CGI-C) outcome measure showed that treatment with Oxbryta compared to placebo resulted in a significantly higher rating of improved overall patient health status after 72 weeks of treatment, regardless of baseline Hb and hemolysis markers. CGI provides an overall clinician-determined summary measure that takes into account available information, including knowledge of the patient’s history, psychosocial circumstances, symptoms and behavior, and the impact of the symptoms on the patient’s ability to function.
  • An analysis of Symphony Health claims data from a subset of 1,275 patients treated with Oxbryta showed that the increase in Hb levels observed in a real-world setting was consistent with published results from the Phase 3 HOPE Study. The data further demonstrated favorable trends in decreasing transfusion and annualized rates of VOCs after the initiation of Oxbryta therapy.
  • An analysis of data from Clinical and Patient Global Impression of Improvement scales (CGI-I and PGI-I) collected from 27 patients treated with Oxbryta at The University of Texas Comprehensive Sickle Cell Center demonstrated that the majority of patients reported substantial improvement in overall clinical status after treatment with Oxbryta, which correlated with the clinician impression of their status.

Pipeline

  • An in vitro study of inclacumab, a novel P-selectin inhibitor in development to reduce VOCs in SCD, demonstrated the potential for a substantially longer duration of exposure and more convenient dosing compared to crizanlizumab.
  • A preclinical analysis demonstrated that GBT021601, GBT’s next generation HbS polymerization inhibitor, tested at lower doses than Oxbryta, was highly effective in reducing hemolysis, increasing hemoglobin levels, prolonging red blood cell (RBC) half-life and improving RBC health as well as potentially improving organ function in SCD transgenic mice.

The ASH abstracts are now available at www.hematology.org. Details of the GBT presentations are as follows:

Saturday, Dec. 5, available virtually from 7 a.m. to 3:30 p.m. P.T.

Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Poster I
Abstract #795: Higher Hemoglobin Levels Achieved with Voxelotor Are Associated with Lower Vaso-occlusive Crisis Incidence: 72-Week Analysis from the HOPE Study
Presenter: Elliott Vichinsky, M.D., UCSF Benioff Children’s Hospital Oakland

Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Poster I
Abstract #802: Improvement in the Clinical Global Impression of Change with Voxelotor in Patients with Sickle Cell Disease in the Phase 3 HOPE Trial
Presenter: Wally Smith, M.D., Virginia Commonwealth University

Sunday, Dec. 6, available virtually from 7 a.m. to 3:30 p.m. P.T.                                                        
Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Poster II
Abstract #1716: Efficacy and Safety of Voxelotor in Adolescents and Adults with Sickle Cell Disease: HOPE Trial 72-Week Analysis
Presenter: Jo Howard, MB BChir, MRCP, FRCPath, Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London

Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Poster II
Abstract #1723: Patient Perception of Oxbryta Treatment Benefit
Presenter: Modupe Idowu, M.D., McGovern Medical School at The University of Texas Health Science Center at Houston

Poster Session: 113. Hemoglobinopathies, Excluding Thalassemia—Basic and Translational Science: Poster II
Abstract #1704: GBT021601 Inhibits HbS Polymerization, Prevents RBC Sickling and Improves the Pathophysiology of Sickle Cell Disease in a Murine Model
Presenter: Kobina Dufu, Ph.D., GBT

Poster Session: 113. Hemoglobinopathies, Excluding Thalassemia—Basic and Translational Science: Poster II
Abstract #1707: Inclacumab, a Fully Human Anti-P-selectin Antibody, Directly Binds to PSGL-1 Binding Region and Demonstrates Robust and Durable Inhibition of Cell Adhesion
Presenter: Xin Geng, Ph.D., GBT

Poster Session: 113. Hemoglobinopathies, Excluding Thalassemia—Basic and Translational Science: Poster II
Abstract #1706: Rheological Impact of GBT1118 Cessation in a Sickle Mouse Model
Presenters: Danitza Nebor, Ph.D., Baylor College of Medicine
Vivian Sheehan, M.D., Ph.D., Baylor College of Medicine

Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Poster II
Abstract #1724: The Impact of Hemoglobin Level on Risk of End-Organ Damage Among Patients with Sickle Cell Disease – A Large-Scale, Longitudinal Analysis
Presenter: William Ershler, M.D., Inova Schar Cancer Institute

Monday, Dec. 7, available virtually from 7 a.m. to 3 p.m. P.T.

Poster Session: 113. Hemoglobinopathies, Excluding Thalassemia—Basic and Translational Science: Poster III
Abstract #2627: Real-World Effectiveness of Voxelotor for Treating Sickle Cell Disease in the U.S.
Presenter: Ahmar Zaidi, M.D., Children’s Hospital of Michigan, Central Michigan University, College of Medicine

GBT Analyst & Investor Day Webcast Details
GBT will host a virtual Analyst & Investor Day event on Monday, Dec. 7, at 4 p.m. P.T. to review data being presented at the 2020 ASH Annual Meeting. The event will also provide an overview of the company’s SCD development pipeline, including inclacumab and GBT021601. The webcast can also be accessed directly at http://www.gbtinvestorday.virtualeventsite.com/. Participants are requested to register in advance. A replay will be available for three months following the event on GBT’s investor webpage at www.gbt.com.

About Sickle Cell Disease
Sickle cell disease (SCD) affects an estimated 100,000 people in the United States,1 an estimated 52,000 people in Europe,2 and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.1 It also affects people of Hispanic, South Asian, Southern European, and Middle Eastern ancestry.1 SCD is a lifelong inherited blood disorder that impacts hemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.3 Due to a genetic mutation, people with SCD form abnormal hemoglobin known as sickle hemoglobin. Through a process called hemoglobin polymerization, red blood cells become sickled – deoxygenated, crescent-shaped, and rigid.3-5 The sickling process causes hemolytic anemia (low hemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen throughout the body. The diminished oxygen delivery to tissues and organs can lead to…

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