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
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a number of risks, uncertainties and important factors that may
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chain, patient enrollment and retention, clinical trials, strategy,
goals and anticipated milestones, as well as global economies and
financial markets; the therapeutic potential of our product
candidates and the timing and completion of our clinical trials and
related data analyses; positive results from a clinical study may
not necessarily be predictive of the results of future or ongoing
clinical studies; any one or more of our product candidates may not
be successfully developed and commercialized; regulatory
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ability to protect and maintain our intellectual property position;
and our ability to fund operations; as well as those risks and
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date hereof and should not be relied upon as representing our views
as of any subsequent date.
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Media: Johanna Bennett, +1 973 600 7925 Porter
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