Updated results from the completed Phase 1 study of etavopivat in patients with sickle cell disease (SCD)
Study design for the Phase 2 Gladiolus Study of etavopivat in patients with transfusion-dependent (TD) SCD or non-TD/TD thalassemia
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, today announced its participation in the European Hematology Association (EHA) 2022 Hybrid Congress, taking place June 9-17, the Foundation for Sickle Cell Disease Research (FSCDR) Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, held June 10-12, and the Global Congress on Sickle Cell Disease (GCSCD), held June 16-18.
Forma’s accepted presentations cover updated results from the open-label extension cohort of the completed Phase 1 study of etavopivat, including an analysis of the frequency and severity of pain-related adverse events, as well as the study design and key enrollment criteria of the Phase 2 Gladiolus Study of etavopivat in TD SCD, non-TD thalassemia and TD thalassemia.
“We believe that data from our Phase 1 study support a highly differentiated etavopivat profile that can potentially improve the lives of patients with SCD by increasing hemoglobin levels, improving red blood cell health, and decreasing vaso-occlusive crises,” said Patrick Kelly, M.D., chief medical officer. “We are pleased to have additional opportunities to share our findings and look forward to attending the upcoming meetings.”
Details of the Forma-led abstracts are below. The EHA abstracts are also currently available online.
EHA Poster Presentation
Abstract #P1495: Etavopivat Treatment for up to 12 Weeks in Patients with Sickle Cell Disease Was Well Tolerated and Improved Red Blood Cell Health
Date/Time: June 10, 4:30-5:45 p.m. CEST
Lead Author: Santosh Saraf, M.D.
EHA Publication
Abstract #PB2232: Trial in Progress: A Phase 2, Open-Label Study Evaluating the Safety and Efficacy of the Erythrocyte Pyruvate Kinase Activator Etavopivat in Patients with Thalassemia or Sickle Cell Disease
Lead Author: Ashutosh Lal, M.D.
FSCDR Oral Presentations
Abstract #1212715: Etavopivat Was Well Tolerated and Improved Red Blood Cell Health in Sickle Cell Disease
Date/Time: June 12, 4:00-4:15 p.m. ET
Presenting Author (Virtual): Santosh Saraf, M.D.
Abstract #1212753: Trial in Progress: The Gladiolus Study, a Phase 2, Open-Label Trial Evaluating the Safety and Efficacy of the PKR Activator Etavopivat (FT-4202) in Patients with Thalassemia or Sickle Cell Disease
Date/Time: June 12, 4:15-4:30 p.m. ET
Presenting Author (Virtual): Ashutosh Lal, M.D.
GCSCD Oral Presentation
Abstract #A34775TM: Etavopivat Treatment for up to 12 Weeks in Patients with Sickle Cell Disease Was Well Tolerated and Improved Red Blood Cell Health
Date/Time: June 16, 7:05 p.m. CEST
Presenting Author: Marilyn Telen, M.D.
GCSCD Poster Presentation
Abstract #A34785TC: Trial in Progress: The Gladiolus Study, A Phase 2, Open-Label Trial Evaluating the Safety and Efficacy of the PKR Activator Etavopivat (FT-4202) in Patients with Thalassemia or Sickle Cell Disease
Date/Time: June 16, 5:30-7:00 p.m. CEST
Presenting Author: Ashutosh Lal, M.D.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company’s beliefs and expectations regarding its: planned presentations at EHA, FSCDR and GCSCD; business plans and objectives; future plans for etavopivat , including expectations regarding potential development expansion plans as well as the enrollment, timing, success and data announcements of planned and ongoing clinical trials; therapeutic potential, clinical benefits, mechanisms of action and safety of our product candidates; upcoming milestones and planned additional trials for the company’s product candidates; growth as a company; and the potential impact of COVID-19 on patient retention and enrollment, future operations or clinical trials. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
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