Press Release

• Aclipse and its collaborators have Keynote and Industry Day presentations at the 7th Annual ALS One Research Symposium
• Poster presentation at the 35th 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 7th 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 35th 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-43Q331K 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 info@aclipsetherapeutics.com.

Contacts
Raymond K. Houck
rhouck@aclipsetherapeutics.com
+1-412-606-7214

Aclipse Therapeutics Expands Drug Development Pipeline with Signing of Exclusive, Worldwide License Agreement with Chong Kun Dang Pharmaceutical Corporation to Develop Potential Disease-Modifying Treatment for Gastroparesis

RADNOR, Pa.–(BUSINESS WIRE)–Aclipse Therapeutics, and its subsidiary, Aclipse Two, Inc (“Aclipse”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, announced today that it has signed an exclusive license agreement with Seoul, South Korea-based Chong Kun Dang Pharmaceutical Corporation (“CKD”) for the worldwide rights (excluding South Korea, Indonesia and Vietnam) to develop CKD’s lobeglitazone for gastroparesis and additional indications. Gastroparesis is the delayed gastric emptying of food in the absence of mechanical obstruction, a condition which affects an estimated 600,000 patients in the U.S. and is increasing due to the increased use of GLP-1 drugs for diabetes and obesity.

Lobeglitazone, given the development code “M107” by Aclipse, was developed by CKD and approved by South Korea’s Ministry of Food and Drug Safety for the treatment of Type 2 Diabetes Mellitus under the brand name, Duvie^®. Lobeglitazone has shown an extensive history of safety, having been dosed in over 3,600 patients and healthy volunteers during its development and post-marketing surveillance.

M107 is an oral, small molecule New Chemical Entity (“NCE”) in the U.S., EU, Japan, and China. With the support of CKD, Aclipse has conducted a successful pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (“FDA”) to align FDA’s view of M107’s existing safety data and Aclipse’s Phase 2 and Phase 3 development plans in gastroparesis.

“The worldwide, exclusive license agreement with CKD expands the Aclipse drug development pipeline and advances the company into Phase 2 clinical development for this promising drug candidate,” said Raymond K. Houck, Chief Executive Officer of Aclipse. “Our collaboration with CKD has been highly productive, allowing us to successfully conduct our pre-IND meeting with FDA and position M107, potentially, as the first disease-modifying treatment for gastroparesis.”

“The license agreement with Aclipse represents an important milestone for lobeglitazone, as it will help to build upon the already extensive safety, efficacy and post-marketing data generated, to date, and provides the opportunity to extend lobeglitazone’s use to additional, key disease indications, worldwide,” said Young-Joo Kim, Chief Executive Officer of Chong Kun Dang Pharmaceutical Corporation. “We look forward to continuing our partnership with Aclipse and to the further clinical and commercial development of lobeglitazone.”

About Gastroparesis

Gastroparesis is the delayed gastric emptying of food in the absence of mechanical obstruction. It is a severe chronic disease that affects an estimated 600,000 patients in the U.S. with those patients having a high hospitalization rate¹. Over half of gastroparesis patients exhibit severe or very severe disease and two-thirds of patients report being dissatisfied with current treatments².Current FDA approved and in-development drugs only treat symptoms of the disease.

About Aclipse Therapeutics

Aclipse Therapeutics is an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases. The company’s current pipeline includes M107, a potential disease-modifying drug for the treatment of gastroparesis proceeding to Phase 2 development, and M102, a dual Nrf2/HSF1 activator for the treatment of ALS and other neurodegenerative diseases proceeding to Phase 1 development. M102 uses a precision medicine approach to identify those ALS patients who are most likely to benefit from the drug. Aclipse has an experienced drug development team and clinical advisory boards of key opinion leaders in gastroparesis and ALS. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

About Chong Kun Dang Pharmaceutical Corporation

Chong Kun Dang Pharmaceutical Corporation (“CKD”) is a South Korea-based, fully integrated pharmaceutical company established in 1941. The company has the capacity to research and develop pharmaceutical products in oncology, neurology, immunology, metabolic disease, and other diseases. Its product portfolio includes prescription products in multiple therapeutic classes as well as consumer products. The company’s Chong Kun Dang Research Institute has three independent laboratories: The New Drug Discovery Labs; The Technology Development Labs; and the Bio Research Labs. CKD’s R&D Investment and efforts are accelerating the development of new drugs, and these efforts are expanding the pipeline for the focused disease areas. Also, CKD manufactures, distributes, imports and exports prescription drugs, OTC drugs, health supplements and consumer health products. The company has manufacturing facilities in Cheonan City, South Korea and is headquartered in Seoul, South Korea.

References:

1. Wadhwa et al., 2017 W J Gastroenterol 23(24) 4428-4436
2. Yu at el., 2017 Dig Dis Sci 62, 879-893

Contacts

Raymond K. Houck
rhouck@aclipsetherapeutics.com
+1-412-606-7214

Aclipse Therapeutics and its subsidiary Aclipse One Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company, today announced that the Company has received a therapeutic development award of $1.475 million from the Congressionally Directed Medical Research Programs (CDMRP) at the United States Department of Defense’s (DOD) U.S. Army Medical Research and Development Command (USAMRDC), as part of its FY21 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award. The award will fund the research by the Company and its collaborator, the Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield in the United Kingdom (UK) entitled, “Development of M102 to Investigational New Drug (IND) Stage for Initiation of Phase I Clinical Trials for Treating Amyotrophic Lateral Sclerosis (ALS).”

CEOCFO Magazine has interviewed Aclipse Therapeutics CEO Raymond Houck. Mr. Houck has introduced the background of the company and our lead drug product M102. He has also described the target pathomechanisms of M102 and its precision medicine approach to ALS and CNS diseases.

Funding Supports Aclipse Therapeutics’ and Sheffield Institute of Translational Neuroscience’s Development of M102 in Amyotrophic Lateral Sclerosis 

Radnor, PA — January 26, 2021 – Aclipse Therapeutics (“Aclipse” or “the Company”), a private biopharmaceutical company, today announced that the Company and its collaborator, The Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield in the United Kingdom (UK), were awarded a drug development research grant of £1.6 million (approximately US $2.2 million) from the UK’s Medical Research Council (MRC), one of the largest funders of medical research worldwide, to support the translational development of M102. M102 is Aclipse’s drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), also referred to as motor neuron disease (MND) or Lou Gehrig’s disease. 

Aclipse Therapeutics was awarded an AUD 1 million (approximately US $720,000) drug development research grant from FightMND, the largest independent funder of ALS research in Australia. The grant will support the translational development of M102, a drug candidate for the treatment of ALS. M102 showed promise to stop and reverse ALS disease progression, as evidenced by data in preclinical models. Currently, there is no cure for ALS and no effective treatments to halt or reverse the progression of this devastating disease.

Aclipse Therapeutics has successfully conducted the US FDA pre-IND meeting for M102. The FDA has reviewed the M102 preclinical data package and confirmed the necessary preclinical studies for M102 to initiate its first-in-human studies. The agency has also provided valuable guidance to support the clinical development of M102.