ANI Pharma Launches Phase 4 Trial to Test Cortrophin Gel Dosing for Gout Flares at Mass General

ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treatment of acute gout flares. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below.

"Gout is a chronic disease that affects millions of patients, including acute flares that can cause extreme pain and temporary disability," said Hyon Choi, MD, DrPH, principal investigator of the study and clinical investigator and physician in the Rheumatology Unit at Mass General Research Institute/Massachusetts General Hospital (MGH). "For some patients, conventional anti-inflammatory treatments do not provide adequate relief from these flares. We look forward to initiating this dose-ranging study, which we believe will provide valuable scientific information about Cortrophin Gel in the treatment of acute gout flares."

Dr. Choi has been a leading physician investigator with a primary focus on gout and other inflammatory arthritic conditions throughout his academic career. He has authored more than 150 gout-related peer-reviewed papers in leading journals, and his findings have been referenced by many articles as well as guidelines from the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Dr. Choi directs the MGH Gout & Crystal Arthropathy Center and co-directs the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN), a non-profit organization dedicated to creating research and education initiatives to fill the knowledge gap in gout.

"This Phase 4 study in gout is the first clinical trial launched by ANI as part of our commitment to building the scientific evidence and clinical data supporting the use of Cortrophin Gel," said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. "Our goal with the study is to generate meaningful clinical information for the dosing of Cortrophin Gel in patients with acute gout flares by comparing the safety and efficacy of two dose levels of the product. We believe this study will provide physicians with more data to inform their approach to patient care."

"We have seen steady growth in the use of Cortrophin Gel as an adjunctive therapy for gout flares since we launched our 1-mL vial, which we developed to help increase access for in-office treatment, in October 2023," said Nikhil Lalwani, President and Chief Executive Officer at ANI. "We believe our new Phase 4 study will provide valuable insights for patients and healthcare providers and further strengthen the profile of Cortrophin Gel in this indication."