Aclipse Therapeutics LLC

Company to advance M107 into Phase 2 clinical development in gastroparesis based on feedback from Pre-IND meeting with FDA 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 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: Wadhwa et al., 2017 W J Gastroenterol 23(24) 4428-4436 Yu at el., 2017 Dig Dis Sci 62, 879-893

RADNOR, Pa.--(BUSINESS WIRE)-- 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. M102 is a potentially disease-modifying drug candidate that has shown promise to impede ALS disease progression in a wide array of preclinical models. Currently, there is no cure for ALS and there are no effective treatments to halt or slow the progression of the disease. “This development funding from MRC is wonderful news for ALS/MND patients who are in dire need of an effective therapy to address this life-threatening neurodegenerative disease,” stated Professor Dame Pamela Shaw, M.D., Director of SITraN and a primary contributor to M102’s development program. “Along with my SITraN colleagues, Dr. Richard Mead and Dr. Laura Ferraiuolo, we spearheaded the ALS/MND biology research that led to the development of M102, including the discovery of a potential precision medicine approach for M102 in ALS/MND, so we are very appreciative of MRC’s funding support.” Aclipse is taking a multiple biological pathway, multiple disease mechanism approach to ALS. M102 activates the NRF2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are recently understood to impact ALS pathophysiology. M102 is expected to be mechanistically superior to currently available drugs and may lead to significant slowing of disease progression in both familial and sporadic ALS. The MRC grant will also support the development of patient stratification biomarkers that will be applied in the M102 clinical studies, potentially enabling a personalized medicine approach in ALS. The goal of the patient stratification biomarkers is to identify M102 drug responders versus non-responders in order to target M102 to those ALS patients most likely to benefit from the drug. “We greatly appreciate the support from MRC for our novel and broad multi-disease patho-mechanism approach to treating ALS patients,” said Raymond K. Houck, CEO of Aclipse Therapeutics. “The MRC award, coupled with our recent FightMND grant award, accelerates M102’s development into its first-in-human clinical studies and validates M102’s biology and potential for a precision medicine approach for the treatment of ALS.” “The research funding from these programs will be key as they will support the completion of our investigational new drug (IND)-enabling work and the regulatory filings for first-in-human studies. Importantly, M102 may have applications in a wide array of conditions associated with impaired neuronal function such as Friedreich’s ataxia, Huntington’s disease and Parkinson’s disease,” added Mr. Houck. 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. There is no cure and limited life-prolonging treatments for the disease. Based on U.S. population studies, approximately 5,600 people in the U.S. are diagnosed with ALS each year and as many as 25,000 Americans have the disease at any given time. About Medical Research Counsel The United Kingdom’s Medical Research Counsel’s mission is to improve human health through world-class medical research. To achieve this, MRC supports research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. MRC works closely with the UK’s National Health Service and the UK Health Departments to deliver its mission and give a high priority to research that is likely to make a real difference to clinical practice and the health of the population. About the Sheffield Institute for Translational Neuroscience The Sheffield Institute for Translational Neuroscience (SITraN) is an international center of excellence recognized for its ground-breaking work in the fight against motor neurone disease and other common neurodegenerative disorders. SITraN brings together 300 staff and research students in multi-disciplinary teams with state-of-the-art laboratories and equipment to study neurological illness. The center is unique in its design to unite clinicians and multidisciplinary teams of scientists to translate discoveries in basic neuroscience into benefits for patients. The SITraN teams have developed a robust portfolio of in vitro and in vivo models to facilitate our understanding of disease mechanisms and identify new targets for therapeutic intervention which can be tested in our BRC experimental medicine programs. The work of SITraN is a major pillar of the University of Sheffield’s cross-faculty Neuroscience Institute, one of four flagship research institutes launched in 2019 to tackle the biggest global challenges through pioneering real-world solutions and involving >120 principal investigators in the Faculties of Medicine, Science and Engineering. About Aclipse Therapeutics Aclipse Therapeutics develops novel and differentiated drugs to treat orphan diseases with significant unmet medical needs. Our lead drug candidate, M102, is in development for the treatment of ALS with potential use in other neurodegenerative diseases such as Friedreich’s ataxia, Huntington's disease and Parkinson's disease. M102 targets multiple disease pathomechanisms and enables a precision medicine approach for the identification of patients who are most likely to benefit from the drug. Aclipse has a very experienced orphan drug management team and a clinical advisory board of the top ALS physicians in the world. For more information about Aclipse, visit the website at or email info@aclipsetherapeutics.com. View source version on businesswire.com: