M-107

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