The company completed a positive Phase IIa trial of the candidate for chronic subjects with peripheral neuropathic pain.
It is now preparing for further clinical development and has sought a pre-investigational new drug (preIND) meeting with the agency to discuss the therapy’s development to treat erythromelalgia, a rare disease marked by severe pain and redness, primarily in the extremities like, hands, feet, nose, and ears, as well as in other body parts.
The agency has provided positive feedback on the continued development of candidate, supporting the initiation of a Phase II/III trial in peripheral neuropathic pain, which could lead to regulatory clearance.
AlzeCure Pharma CMO Märta Segerdal said: “We are of course very happy about this good news. The granting of orphan drug status for ACD440, combined with the positive interaction and response we have received from the FDA regarding our preIND application for a pivotal phase II/III study, gives us increased opportunities to offer these very severely affected patients an effective treatment.”
ACD440 is a topical TRPV1 antagonist and is being developed as a gel. This formulation is designed to minimise systemic exposure while ensuring high local concentrations for prolonged analgesic action.
AlzeCure Pharma CEO Martin Jönsson said: “Orphan drug status provides a number of very important benefits, with the possibility of a faster path to approval through processes such as accelerated or conditional approval, as well as priority review.
“In addition, stronger and extended market exclusivity is provided, which strengthens our competitive advantages and the conditions for out-licensing this important and promising project.”