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

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  • 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

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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 Announces Publication in Nature Reviews Drug Discovery of an Amyotrophic Lateral Sclerosis Review including M102, a First Targeted Therapy for Sporadic ALS

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  • The Nature Reviews Drug Discovery article describes the current state of ALS drug development for both preclinical and clinical stages, as well as examples of translational science including for Aclipse’s M102 candidate.
  • M102 is in preclinical development for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
  • M102 development is financially supported by the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

Radnor, PA, USA – January 2, 2023 – Aclipse Therapeutics, and its subsidiary Aclipse One, Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, announced today that Nature Reviews Drug Discovery published on December 21, 2022 in Volume 22, Issue 12 a review article entitled Amyotrophic Lateral Sclerosis: a neurodegenerative disorder poised for successful therapeutic translation with authors Richard J. Mead, Ning Shan, H. Joseph Reiser, Fiona Marshall, and Pamela J. Shaw.  Authors from both the Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield, United Kingdom and Aclipse review the current state of ALS drug development and provide examples of translation for several drug candidates, including for Aclipse’s M102 candidate.

M102 is in late-stage IND-enabling studies for the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease. M102 takes a dual mechanism approach with M102 activating both the Nrf2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are understood to impact ALS pathophysiology. The Company is taking a targeted, precision approach to the development of M102 by identifying genetic markers of potential ALS drug responders. Industry data indicate that a precision medicine approach may increase the probability of clinical success by 2- to 3-fold.   

Aclipse licensed M102 from SITraN and is developing M102 along with SITraN collaborators Professor Dame Pamela Shaw, Professor Laura Ferraiuolo, and Dr. Richard Mead. M102 development has been supported by research grants from the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

“The publication of this Nature Reviews Drug Discovery article is an important step in the collaboration between SITraN and Aclipse to develop M102 for use in ALS patients who are in urgent need of effective therapies. Based on preclinical results to date, M102 may be mechanistically superior to currently approved ALS drugs and may lead to significant slowing of disease progression in patients with ALS with potential impact in other neurodegenerative diseases such as Fredrich ataxia and Parkinson’s disease,”
stated Ning Shan, PhD., Chief Scientific Officer of Aclipse Therapeutics and co-author of the Nature Reviews Drug Discovery article.

About ALS/MND

Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. Based on population studies, as many as 25,000 Americans have ALS at any given time.

About Aclipse Therapeutics

Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. M102 is a dual Nrf2/HSF1 activator for the treatment of ALS and other neurodegenerative diseases. 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 a clinical advisory board of key opinion leaders in ALS.  For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

Contact:

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

Aclipse Therapeutics Announces Issuance of Composition-of-Matter Patent for M102, a First Targeted Therapy for Sporadic ALS

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  • The US Patent and Trademark Office’s patent issuance marks the first patent issuance to Aclipse for M102’s four patent families.
  • M102 is in preclinical development for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
  • M102 is financially supported by the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

Radnor, PA, USA – November 10, 2022 – Aclipse Therapeutics, and its subsidiary Aclipse One, Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, announced today that the U.S. Patent and Trademark Office (USPTO) has issued patent no. 11,459,301 entitled, “Crystalline Form of S-Apomorphine”. The patent protects the composition-of-matter of the Company’s M102 drug candidate as well as the related methods of use, with expected patent protection to at least 2039.

Aclipse is conducting IND-enabling studies for M102 for the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease. M102 takes a dual mechanism approach to the treatment of ALS with M102 activating both the Nrf2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways. The Company is taking a targeted, precision approach to the development of M102 by identifying genetic markers of potential ALS drug responders. Industry data indicates that a precision medicine approach increases the probability of clinical success by 2- to 3-fold.

Aclipse licensed M102 from the Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield, United Kingdom and is developing M102 with Professor Dame Pamela Shaw, MD and her team at SITraN with support from the United Kingdom’s Medical Research Council, Australia’s FightMND, and the United States Department of Defense through its U.S. Army Medical Research and Development Command.

“This patent issuance is an important step in the development of M102 for use in ALS patients who are in urgent need of effective therapies. Based on preclinical results to date, M102 may be mechanistically superior to currently approved ALS drugs and may lead to significant slowing of disease progression in patients with ALS with potential impact in other neurodegenerative diseases,”
stated Raymond K. Houck, Chief Executive Officer of Aclipse Therapeutics.

About ALS/MND
Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. Based on population studies, as many as 25,000 Americans have ALS at any given time.

About Aclipse Therapeutics
Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. M102 is a dual Nrf2/HSF1 activator for the treatment of ALS and other neurodegenerative diseases. 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 a clinical advisory board of key opinion leaders in ALS. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

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

Aclipse Therapeutics Receives Positive Feedback from the US Food and Drug Administration on M107 for the Treatment of Gastroparesis

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FDA supports the initiation of Aclipse Therapeutics’ Phase 2 development of M107
for Idiopathic Gastropareses

Radnor, PA, USA – July 18, 2022 – Aclipse Therapeutics and its subsidiary Aclipse Two Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, today announced that the Company has received feedback from the US Food and Drug Administration (“FDA”) in a pre-Investigational New Drug (“pre-IND”) meeting. The FDA stated that pending review of the IND the Company’s nonclinical and clinical study package appears to be adequate to support the initiation of the Company’s proposed phase 2 dose-ranging efficacy study titled, “Randomized Double-blind Placebo Controlled Study of M107 for the Treatment of Idiopathic Gastroparesis”. The Company plans to submit extensive ex-US clinical experience in support of the IND. In addition, the FDA provided various comments and suggestions on the Company’s plans for phase 2 and 3 clinical designs, primary and secondary endpoints, safety database, as well as chemical, manufacturing and controls (“CMC”) development.

M107 is 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. M107 seeks to treat the underlying pathology of gastroparesis by switching human pro-inflammatory M1 macrophages to anti-inflammatory M2 macrophages. M107 lowers inflammation in the stomach and increases the population of the interstitial cells of Cajal (i.e., the pacemaker cells of the stomach), allowing for increased stomach emptying and function and decreased fibrosis of the stomach pylorus.

Gastroparesis affects approximately 600,000 patients in the US and similar numbers in the EU. Gastroparesis patients with severe disease have frequent hospitalizations and limited treatment options. Both current FDA-approved drugs and existing clinical-stage drug candidates for gastroparesis target only the symptoms of the disease. Approximately half of gastroparesis patients suffer from idiopathic disease, indicating that their disease is due to unknown causes, while most of the remaining patients have underlying diabetes.

“I am thrilled with the FDA response to Aclipse’s proposed phase 2 dose-ranging clinical trial plan and the path to initiate our M107 human trial. We can now move forward to completing phase 2 manufacturing for the clinical supply and filing of the M107 IND submission to FDA.”
said Raymond K. Houck, Chief Executive Officer of Aclipse Therapeutics.

About Aclipse Therapeutics
Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. Aclipse has two programs M107, a potential first disease-modifying agent for the treatment of gastroparesis, and M102, a dual Nrf2/HSF1 activator, and a potential first targeted medicine for the treatment of sporadic amyotrophic lateral sclerosis (ALS) patients. 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 a clinical advisory board of key opinion leaders in its respective diseases. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

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

Aclipse Therapeutics receives a therapeutic development award of $1.475 million

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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).”

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Aclipse Therapeutics Announces $2.2 Million Grant from UK’s Medical Research Council for Development of M102

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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. 

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