SynAct Pharma has announced that it has received clearance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for a Phase 2a/b study in Rheumatoid Arthritis (RA) with the company’s lead compound AP1189.
The IND was submitted to the FDA Division of Rheumatology and Transplant Medicine (DRTM) on September 30, 2022, sponsored by SynAct. On October 31, FDA confirmed by email that as of October 30, 2022, the IND-initiating study, RESOLVE, was safe to proceed.
An important milestone
“This IND clearance is an important milestone for SynAct and for AP1189. It marks the initiation of regulatory and clinical processes in the US and a true globalization of the development program for AP1189. We are looking forward to collaborating with investigators and well renowned key opinion leaders in the further development of AP1189 in the US and in the conduct of the RESOLVE study. We believe AP1189 can make a great impact with its new and unique mode of action for oral treatment of inflammatory and auto-immune diseases,” says Thomas Jonassen, CSO at SynAct. “Inclusion of the US in the development program is very important for our discussions with potential business partners. Also, it opens up the US market, the world’s biggest and most important pharma market, where RA in itself has an estimated market value of approximately USD 20 billion annually.”
SynAct expects that AP1189, a selective melanocortin receptor agonist, could be very well suited as a once-daily oral treatment therapy for inflammatory and auto-immune diseases, such as RA. AP1189 has been effective, safe and well-tolerated in previous clinical studies. Also, it has a favorable patent situation, with coverage beyond 2040.
RESOLVE, which is SynAct’s fifth approved clinical Phase 2 study in three different diseases of which two are completed, will be conducted at five clinical sites in the US as well as 12 sites in Bulgaria and Moldova, where Clinical Trial Applications are pending review by the local authorities and ethics committees. The successful outcome of the IND application review implies that SynAct can initiate the clinical development of AP1189 in USA immediately.
Photo of Jeppe Ovlesen: SynAct Pharma