Efficacious Exposure Range Achieved With No Safety Concerns and Proceeding to Repeat Dose Stage
October 18, 2021, Seattle, WA – Seal Rock Therapeutics, Inc., a clinical stage biotechnology company developing a platform of first-in-class and best-in-class therapeutic kinase inhibitors for treatment of severe fibrotic and inflammatory diseases with limited or no available therapies, today announced completion of the single ascending dose (SAD) portion of its Phase 1 clinical trial of SRT-015, a next-generation, liver-selective inhibitor of Apoptosis Signal-regulating Kinase 1 (ASK1) for Non-Alcoholic SteatoHepatitis (NASH) and other liver diseases such as Alcoholic Hepatitis (AH)
This randomized, double-blind, placebo-controlled trial (Clinicaltrials.gov Identifier: #NCT04887038) is evaluating SRT-015 in up to 96 healthy volunteers to assess safety, tolerability and pharmacokinetics. The trial is being conducted in three parts. The first evaluated single ascending oral doses of SRT-015 or placebo. The second evaluates repeat ascending oral doses of SRT-015 or placebo and will be followed by the third part to evaluate for possible food effect on treatment.
“We are pleased to have completed the first part of our first-in-human trial with no safety signals and are now proceeding with the repeat-dose evaluation,” said Neil McDonnell, Chief Executive Officer of Seal Rock Therapeutics.
Completion of the entire Phase 1 study is anticipated by the end of this year and will be followed by a Ph 2a proof of clinical activity trial in presumed NASH patients. Previously reported data demonstrated superior pharmacological properties and efficacy of SRT-015 compared to other ASK1 inhibitors including substantial improvement of SRT-015-treated animals in the gold standard diet induced obesity -NASH mouse model.
SRT-015 is the next generation inhibitor of ASK1, developed internally by Seal Rock Therapeutics with the goal of overcoming liabilities that limited the clinical efficacy of selonsertib, the first ASK1 inhibitor to reach clinical development. Optimized to overcome such liabilities, and with a liver-preferential distribution, the excellent preclinical safety profile of SRT-015 positions it as a first-in-class product candidate for NASH and also AH.
About Seal Rock Therapeutics
Led by an experienced management team with a long track record of successful drug discovery, development and commercialization, Seal Rock Therapeutics is a privately held, clinical stage company based in Seattle, WA focused on developing a platform of well-validated first-in or best-in-class kinase inhibitors. Its lead clinical indication is NASH while the company’s R&D pipeline offers additional compelling high unmet need disease opportunities, including alcoholic hepatitis, chronic kidney disease, heart failure and Parkinson’s disease. Seal Rock is currently raising Series A funding to complete all phase 2-readiness activities for SRT-015 and continue advancement of its other pipeline products. For more information, please visit www.sealrocktx.com.
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