Stoke Therapeutics: Initial Safety Data From MONARCH Study Highly Encouraging

Stoke Therapeutics, Inc. (STOK) reported positive safety, pharmacokinetic and cerebrospinal fluid exposure data from a planned interim analysis of the open-label phase 1/2a MONARCH study of STK-001 in children and adolescents with Dravet syndrome. An interim analysis of the MONARCH study showed that single doses of STK-001 up to 30mg and multiple doses of STK-001 at 20mg were found to be well-tolerated with no safety concerns. The company said it now has greater clarity on the dose levels that are likely to be pharmacologically active in patients.

"We look forward to continuing our two ongoing studies as we work to identify a dose level that has the potential to maximize efficacy while minimizing treatment frequency for patients with Dravet syndrome," said Barry Ticho, Chief Medical Officer.

The company also provided several updates on the clinical progress of STK-001. In September, the first patient was dosed in the 30mg MAD portion of the phase 1/2a MONARCH study. The FDA will allow the company to add an additional higher dose level (45mg) to the SAD and MAD portions of the MONARCH study.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Merck & Co., Inc., known as MSD outside the U.S. and Canada, has recalled one lot of intravenous antibiotic Cubicin (daptomycin for injection) 500 mg for the potential presence of particulate matter identified as glass particles, the U.S. Food and Drug Administration or FDA said in a statement. The National Restaurant Association or NRA shot out a letter to the U.S. Conference of Mayors suggesting that expanded outdoor dining is the need of the hour for the restaurant industry to sustain the winter. The NRA also warned that thousands of restaurants without this facility could close down very soon. The U.S. Food and Drug Administration is investigating a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions. The outbreak has resulted in 652 illnesses in consumers across the U.S. to date. The traceback investigation has identified Hailey, Idaho -based ProSource Inc., also known as ProSource Produce, LLC, as a source.
Follow RTT