vein thrombosis. During the four weeks post-treatment, three patients reported four serious AEs, all grade 3 and considered unrelated to etavopivat, including VOC, syncope, and acute chest syndrome and VOC following a respiratory infection.
Etavopivat multimodal mechanism of action improved biomarkers of RBC health and SCD in exploratory analyses
Findings from exploratory analyses showed improvements in RBC health and function as measured by biomarkers of SCD during 12 weeks of etavopivat therapy.
Etavopivat’s multimodal mechanism of action via PKR activation resulted in increased adenosine triphosphate (ATP), and decreased 2,3-diphosphoglycerate (2,3 DPG), which was sustained during 12 weeks of etavopivat treatment. Four weeks post treatment, ATP and DPG levels gradually returned to pre-treatment levels, suggesting the potential durability of etavopivat on RBC health may persist for 1-4 weeks following the treatment period.
Surrogate marker results showed etavopivat normalized the affinity of hemoglobin for oxygen, resulting in improved oxygen release in the peripheral tissues and reducing RBC sickling. Further analysis after two weeks of etavopivat treatment support improved RBC membrane health, with increased levels of two enzymes important to reducing oxidative stress in sickled RBCs: superoxide dismutase activity (SOD, p<0.05) and glutathione reductase activity (GSH, p<0.001), as well as significantly repairing membrane damage, as measured by phosphatidylserine (PS, p<0.01). Additionally, up to 12 weeks of etavopivat showed promising trends in reducing systemic biomarkers of inflammation and coagulation. Significant decreases were observed in TNF-alpha (p<0.001), prothrombin 1.2 (p<0.05), and D-dimer (p<0.01). In addition, improved oxygen delivery was observed as measured by significant decreases in erythropoietin levels (p<0.05).
Additional Clinical Updates
Additional etavopivat trials to begin late 2021/1H:22 and Hibiscus Study interim analysis update
The Company plans to initiate a Phase 2 trial in transfusion dependent SCD and both transfusion dependent and independent thalassemia prior to the end of the year, and a pediatric SCD trial beginning in the first half of 2022. The Company currently plans to conduct the first interim analysis in the Hibiscus Study in the latter part of 2022.
Additional FT-7051 clinical results in mCRPC to be presented in 2022
Men with metastatic castration-resistant prostate cancer (mCRPC) continue to be enrolled in the dose escalation portion of the Phase 1 trial. The Company plans to present updated results from the trial at a scientific conference in mid-2022.
Forward-looking Statements
The disclosure under this Item 8.01 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: future plans for the Company’s product candidates, including expectations regarding timing, trial enrollment, success and data announcements of the Company’s current and planned clinical trials; initial results for the etavopivat open label extension cohort of the Company’s Phase 1 clinical trial; therapeutic potential, clinical benefits, mechanisms of action as well as tolerability and safety of the Company’s product candidates; upcoming milestones and planned additional trials for the Company’s product candidates; presentation of data at upcoming scientific conferences; and the potential impact of COVID-19 on patient retention and enrollment, future operations, clinical trials or planned regulatory filings. 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 under this Item 8.01 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