Aclipse Therapeutics Selected to Present M102 ALS Clinical Development Program at Prestigious ALS and Motor Neurone Disease Symposia

• Aclipse and its collaborators have Keynote and Industry Day presentations at the 7^th Annual ALS One Research Symposium
• Poster presentation at the 35^th International Symposium on ALS/Motor Neurone Disease
• M102, an NRF2 and HSF1 activator, to initiate Phase 1 human trials in Q1 2025

KING OF PRUSSIA, Penn.--(BUSINESS WIRE)--Aclipse Therapeutics LLC (“Aclipse” or “the Company”) today announced that its M102 drug development program has been selected for presentations at the premier amyotrophic lateral sclerosis (ALS) and motor neurone disease (MND) symposia this fall.

“These important meetings bring together the leading ALS researchers, clinicians, care providers, drug developers, and industry partners from around the world to share and advance the development of new treatments for this devastating disease,” said Aclipse CEO Raymond Houck. “We and our partner, the Sheffield Institute for Translational Neurosciences (SITraN, UK), are excited to share our progress and future plans to bring M102 into the clinic for ALS patients.”

Conference Events:

Professor Dame Pamala Shaw, M.D., who heads SITraN, one of the largest ALS/MND science teams in the world, will present a keynote presentation on the “Subclassification and Therapeutic Approaches for Sporadic ALS” on the opening day of the 7^th Annual ALS Research Symposium, November 13, 2024. Professor Shaw is the founding member of Aclipse’s Clinical Advisory Board. Professor Shaw and her lab discovered the M102 biology and molecule.

Aclipse’s Chief Medical Officer Dr. Ira Kalfus will present on M102 at the Industry Day of this symposium on November 14, 2024. Dr. Kalfus’ presentation will highlight the M102 dataset indicating the potential for ALS disease-modification and reversal, our efforts to stratify patients into those with the highest probably of drug response, and our clinical development plans in ALS.

At the 35^th International Symposium on ALS and Motor Neurone Disease on December 6 to 8, 2024 in Montreal, Canada, Dr. Amy Keerie, a leading SITraN researcher, will report on M102’s ability to significantly improve compound muscle action potential (CMAP), weight, and gait parameters in the TDP-43^Q331K animal model of ALS in a dose dependent manner, correlating with the preservation of motor neurons.

“With strong data in two well characterized models of ALS and rigorous pre-clinical development, we look forward to working with the ALS community and advancing of M102 into the clinic for ALS patients, and potentially in other neurodegenerative diseases where M102 motor neuron protection can improve patient lives,” said Mr. Houck.

About M102

M102 is a potential disease-modifying, once daily orally administered, small molecule, new chemical entity (NCE). M102 takes a broad mechanistic approach to treat the complexity of ALS (also known as Motor Neurone Disease) with dual activation of NRF2 and HSF1 pathways that affect multiple ALS pathomechanisms. Aclipse is also developing patient stratification approaches for sporadic ALS patients that may allow for improved clinical outcomes.

About Aclipse Therapeutics

Aclipse Therapeutics develops novel and highly differentiated neuromuscular therapeutics to treat life-threatening and severe diseases. Our approach leverages the wealth of human genomic, proteomic and biomarker data to develop disease-modifying drug candidates. Aclipse focuses on molecular pathways that regulate cellular stress, protein misfolding and inflammation in neuromuscular diseases that are strongly impacted by these molecular pathways. In addition to our M102 motor neuron protectant program, we are preparing to launch our M107 drug into a Phase 2 trial next year as the first potential disease-modifying drug candidate for the treatment of gastroparesis, a chronic and serious gastrointestinal disease affecting stomach nerves and muscles resulting in stomach paralysis and delayed stomach emptying. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email [e-mail].