Forma Therapeutics Announces Four Presentations on Etavopivat and Olutasidenib at Upcoming 2021 ASH Annual Meeting
Two oral presentations on etavopivat include data from Forma's Phase 1 open label extension trial in sickle cell disease demonstrating a favorable tolerability profile consistent with previously-reported results
Additional data supports improvement in markers of red blood cell health for people living with sickle cell disease
One oral and one poster presentation include data from ongoing Phase 2 trial of olutasidenib as a single agent and in combination with azacitidine supporting a favorable tolerability profile, clinical activity and induction of a durable composite complete remission (CR) or CR plus CR with partial hematologic recovery (CRh) in high-risk patients with mIDH1 AML
Two oral presentations will feature clinical data on a Phase 1 trial of etavopivat, the company's oral, once-daily, selective pyruvate kinase-R (PKR) activator for the treatment of sickle cell disease (SCD). One abstract evaluates the ability of etavopivat to improve anemia and decrease intravascular hemolysis. A second abstract shows the effects of etavopivat on improving red blood cell health and lifespan, as well as reduction in systemic markers of inflammation and hypercoagulability. A third abstract highlights clinical data from the Phase 2 trial of olutasidenib, the company's selective inhibitor for cancers with mutations in isocitrate dehydrogenase 1 (IDH1m) being evaluated in patients with relapsed/refractory acute myeloid leukemia (R/R AML).
"We're pleased that these abstracts were selected for oral and poster presentation at the ASH annual meeting," said
The abstracts are currently available on the ASH website.
Title: FT-4202, Activation of Pyruvate Kinase-R with Etavopivat (FT-4202) Is Well Tolerated, Improves Anemia, and Decreases Intravascular Hemolysis in Patients with Sickle Cell Disease Treated for up to 12 Weeks
Title: FT-4202, Etavopivat, an Allosteric Activator of Pyruvate Kinase-R,
Title: FT-2102, Olutasidenib (FT-2102) in Combination with Azacitidine Induces Durable Complete Remissions in Patients with mIDH1 Acute Myeloid Leukemia
Title: FT-2102, Molecular Characteristics of Response to Olutasidenib (FT-2102) in Patients with Relapsed/Refractory mIDH1 Acute Myeloid Leukemia
Etavopivat is an investigational, once-daily, selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, etavopivat is designed to work by activating the RBCs' natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce polymerization and RBC sickling. Etavopivat-mediated PKR activation also increases ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, etavopivat did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development. Etavopivat has been granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the
Olutasidenib is an oral, potent, small-molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing a new drug application (NDA) for submission to the
IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.
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 future plans for etavopivat and olutasidenib, including expectations regarding timing, success and data announcements of our current ongoing clinical trials; therapeutic potential, clinical benefits, mechanisms of action and safety of our product candidates; planned regulatory submissions, including an NDA for olutasidenib; and our planned presentation of data at the ASH annual meeting. 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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