AlzeCure receives positive FDA response regarding Phase II/III studies with ACD440 in a rare disease

STOCKHOLM, SE / ACCESS Newswire / June 12, 2025 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) - AlzeCure Pharma AB (publ) (FN STO:ALZCUR), a pharmaceutical company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced it has received a positive response from the US Food and Drug Administration (FDA) regarding the preIND application submitted in advance of a planned application for orphan drug status.

"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 program. 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, the company's lead drug candidate within the Painless platform, has previously completed a positive Phase IIa clinical trial in patients with chronic peripheral neuropathic pain. Ahead of the next clinical development stage, AlzeCure applied for a preIND meeting with the FDA regarding the further development of ACD440 as a drug for the treatment of this rare disease.

AlzeCure has now received a positive guidance response after a meeting with the FDA that supports the continued development program for ACD440 in the treatment of the rare pain disorder erythromelalgia. In the meeting, the FDA confirmed that there is a significant medical need in the indication, which affects both children and adults. The scientific rationale was also supported by the authority. The results of the meeting provide strong support for the continued development of the registration-based program with ACD440.

Erythromelalgia is a rare chronic disease that affects an average of 1-4 out of 100,000 people and is characterized by intense burning pain and severe redness of the skin. The disease most often occurs in the extremities such as the feet, hands, ears and nose, but can also occur in other parts of the body. The affected part of the body often swells and the skin becomes very hot. There is currently no approved treatment available for patients suffering from erythromelalgia, so the medical need is very great.