AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of small molecule drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that it has received a response from the US Food and Drug Administration (FDA) regarding the preIND application that was submitted prior to the planned phase IIa study with ACD440 in neuropathic pain.
ACD440, which is the company's leading drug candidate in the Painless platform, completed a positive phase Ib study in 2021 and the company now plans to initiate a clinical phase IIa study in patients with peripheral neuropathic pain. Prior to this clinical development step, a preIND application was submitted to the FDA. AlzeCure has now received indicative answers that support the continued development program for ACD440, as well as the preparatory work for the upcoming clinical phase IIa study.
ACD440 is a TRPV1 antagonist for the topical treatment of patients with neuropathic pain. The discovery of TRPV1, which is the basis for the project, was awarded the Nobel Prize in Physiology or Medicine in 2021.
“With the responses from the FDA, we can now proceed as planned regarding the next clinical phase, a planned phase IIa study in patients. The answers we received from the FDA have given us good guidance for the project. Our project team for ACD440 for neuropathic pain has done an excellent job,” said Martin Jönsson, CEO of AlzeCure Pharma.
“The medical need for neuropathic pain is enormous. Over 60% of patients in the United States have been prescribed opioids, which can be very problematic. With our project, we want to develop an efficient and safer alternative. As the medical need is so great, our ambition is to be able to get a Fast Track Designation from the FDA in order to make our potential drug available to patients more quickly."
