Forma Therapeutics Announces Presentations at Upcoming Hematology Conferences

Rhea-AI Summary

Forma Therapeutics (NASDAQ: FMTX) announced updated results from its Phase 1 study of etavopivat in sickle cell disease, highlighting its potential to improve hemoglobin levels and reduce vaso-occlusive crises.

The company will present findings at several upcoming conferences, including the European Hematology Association and the Global Congress on Sickle Cell Disease.

These presentations will focus on the treatment's tolerability and efficacy, marking a crucial step in the development of therapeutics for sickle cell disease and related hematologic conditions.

Positive

• Updated results indicate etavopivat improves hemoglobin levels and red blood cell health.
• Well-tolerated treatment observed in Phase 1 study.
• Strong pipeline with ongoing Phase 2 Gladiolus Study for etavopivat in TD SCD and thalassemia.

Negative

• None.

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

WATERTOWN, Mass.--(BUSINESS WIRE)-- 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.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company’s business, operations, supply 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 developments in the United States and foreign countries; our ability to protect and maintain our intellectual property position; and our ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our most recent annual report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and subsequent filings with the SEC. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220610005055/en/

Media:

Johanna Bennett,  +1 973 600 7925

Porter Novelli 

johanna.bennett@porternovelli.com

Investor:

Adam Bero, Ph.D.

Kendall Investor Relations

abero@kendallir.com

Source: Forma Therapeutics Holdings, Inc.

FAQ

What are the latest results from Forma Therapeutics' etavopivat Phase 1 study?

The updated results show etavopivat improves hemoglobin levels and is well-tolerated in patients with sickle cell disease.

What conferences is Forma Therapeutics participating in June 2022?

Forma Therapeutics will present at the European Hematology Association Congress, FSCDR Symposium, and GCSCD.

What is the Gladiolus Study related to Forma Therapeutics?

The Gladiolus Study is a Phase 2, open-label trial evaluating etavopivat's safety and efficacy in patients with transfusion-dependent sickle cell disease and thalassemia.

When will Forma Therapeutics present at the EHA Congress?

Forma Therapeutics' presentations at the EHA Congress are scheduled for June 10, 12, and 16, 2022.

How does etavopivat affect patients with sickle cell disease?

Etavopivat is designed to improve red blood cell health and decrease the frequency of vaso-occlusive crises in sickle cell disease patients.