AlzeCure Pharma has received a positive response from the FDA on its preIND application submitted before its planned application for orpahn drug status.
ACD440 is the company's lead drug candidate, and has previously completed a positive Phase IIa clinical trial in patients with chronic peripheral neuropathic pain.
Following this trial, AlzeCure applied for a preIND meeting with the FDA to discuss the further development of ACD440 as a drug for the treatment of erythromelalgia, a rare disease impacting 1–4 out of 100,000 people.
Those who have the condition experience intense burning pain and severe skin redness, occurring most often the extremeties, such as the hands, feet, ears and nose.
There are no treatments currently available for those with erythromelalgia, so there is a clear unmet medical need in this patient group.
“We are very pleased with the meeting and interaction with the FDA, and with the positive response from the agency, we can now move forward with our planning for the continued clinical development programme," stated Märta Segerdahl, CMO at AlzeCure Pharma.
"The response we have received from the FDA has provided us with good guidance for the project, where our ACD440 project team has done an excellent job,” said Märta Segerdahl, CMO at AlzeCure Pharma.
ACD440 is a first-in-class topical TRPV1 antagonist, and was awarded a Nobel Prize in 2021.
”Orphan drugs tend to have a faster path to market via a limited study programme, as well as extended market exclusivity upon approval — generating interest among potential recipients," noted Martin Jönsson, CEO of AlzeCure Pharma.
"This also increases the possibility of out-licensing, so we are excited to progress ACD440 further," he concluded.
