Aclipse Therapeutics

Aclipse Therapeutics, a private biopharmaceutical company founded in 2017, is focused on developing novel drugs for severe and life-threatening diseases, particularly in the neuromuscular space. The company was established by co-founders Raymond Houck, who serves as CEO, and Ning Shan, the Chief Scientific Officer. Houck is a serial entrepreneur with a background in co-founding and leading technology and biopharmaceutical companies, including Thar Pharmaceuticals, which was acquired by Grünenthal GmbH. This experience in drug and product development, capital markets, and M&A informs Aclipse's strategy. The company's business model is centered on in-licensing promising drug candidates and advancing them through to FDA and EMA approval.

The company's operations are based in Radnor, Pennsylvania. Aclipse has secured approximately $2.56 million in funding through various rounds, including grants from notable bodies like the U.S. Department of Defense, the UK's Medical Research Council, and Australia's FightMND. This funding supports the development of its therapeutic pipeline. The core of Aclipse's strategy involves leveraging genomic, proteomic, and biomarker data to create disease-modifying drug candidates. A significant aspect of their approach is the use of precision medicine to identify patient subgroups most likely to respond to a given therapy, which could enhance clinical trial success rates.

Aclipse's lead product candidate is M102, a potential treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. M102 is a once-daily, orally administered small molecule designed to tackle the multifaceted nature of ALS by dually activating the NRF2 and HSF1 molecular pathways. These pathways are crucial in managing cellular stress, protein misfolding, neuro-inflammation, and mitochondrial dysfunction, all of which are implicated in ALS progression. The biology and the molecule itself were discovered and developed in collaboration with the Sheffield Institute for Translational Neuroscience (SITraN) in the UK, a world-leading ALS research center. M102 has demonstrated the ability to stop and even reverse disease progression in preclinical models and is expected to enter Phase 1 human trials. The company's second key candidate, M107, is being developed as a potential disease-modifying treatment for gastroparesis, a condition that causes stomach paralysis. M107 aims to reduce inflammation and restore stomach function by targeting macrophages. The FDA has provided positive feedback for the initiation of a Phase 2 trial for M107.

Keywords: biopharmaceutical, neuromuscular diseases, orphan drugs, drug development, ALS treatment, amyotrophic lateral sclerosis, M102, neurodegenerative diseases, Raymond Houck, Ning Shan, gastroparesis, M107, precision medicine, clinical trials, cellular stress, protein misfolding, inflammation, NRF2 activator, HSF1 activator, SITraN, small molecule therapeutics, orphan drug designation, motor neurone disease, therapeutic biomarkers