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