Press release
Fulcrum Therapeutics Reports Recent Business Highlights and Second Quarter 2021 Financial Results
– Reported positive interim results from ongoing Phase 1 trial in healthy adult volunteers with FTX-6058 for sickle cell disease demonstrating proof of
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"– Reported positive interim results from ongoing Phase 1 trial in healthy adult volunteers with FTX-6058 for sickle cell disease demonstrating proof of mechanism and proof of biology – – Company plans to initiate enrollment in a Phase 1b clinical trial in sickle cell patients in 4Q 2021 – – Cash runway into 1Q 2023 – – Conference call scheduled for 8:00 a.m. ET today – CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today provided a business update and reported financial results for the second quarter of 2021. “This quarter was marked by meaningful progress, particularly as we furthered our efforts with our lead candidates for FSHD and sickle cell disease,” said Bryan Stuart, president and chief executive officer. “We made groundbreaking progress with losmapimod and reported clinical data from ReDUX4 demonstrating slowed disease progression and improved function in FSHD. We are also pleased with the dose proportional target engagement data, fetal hemoglobin (HBG) mRNA induction and F-reticulocyte increases that we observed in our ongoing Phase 1 trial in healthy adult volunteers with FTX-6058, demonstrating proof of mechanism and proof of biology. These results, along with the safety, tolerability and pharmacokinetics observed to date, reinforce our belief in FTX-6058’s potential to be a best-in-class treatment for select hemoglobinopathies. Our team continues to optimize the potential of FulcrumSeek™, our proprietary product engine. Driven by our focus on the patient and our ability to rapidly identify novel, high quality targets that modulate the root cause of genetically defined rare diseases, we are on track to submit two investigational new drug applications (INDs) by the end of the first quarter of 2023. With these important advances and cash runway that takes us into the first quarter of 2023, we believe we are well positioned to continue to build on our momentum to bring important therapies to patients with genetically defined rare diseases.” Recent Business Highlights Reported positive interim results today from the ongoing single- and multiple-ascending dose (SAD and MAD) Phase 1 trial in healthy adult volunteers with FTX-6058. FTX-6058 is an invest...