AlzeCure Pharma has received approval from the regulatory authorities in Sweden to initiate its clinical phase IIa study with the drug candidate ACD440 in patients with peripheral neuropathic pain.

”We now have all regulatory approvals in place to be able to start the phase IIa study with ACD440. We expect to be able to initiate the study soon and present results in 2023,” says Märta Segerdahl, CMO at AlzeCure Pharma.

The Phase IIa study is AlzeCure’s second clinical study with ACD440, the company’s leading drug candidate in the Painless platform. ACD440 is under development as a local treatment for peripheral neuropathic pain, such as long-term pain after shingles and diabetic neuropathy. The aim of the study is to evaluate the analgesic effects of the drug candidate in patients with peripheral neuropathic pain, but also its tolerability after repeated dosing.

“The discovery and insight into TRPV1, the biological system that underlies ACD440 and is central to, among other things, temperature regulation and pain, was awarded the Nobel Prize in Physiology or Medicine 2021.”

ACD440 is a TRPV1 antagonist that originated in Big Pharma. The discovery and insight into TRPV1, the biological system that underlies ACD440 and is central to, among other things, temperature regulation and pain, was awarded the Nobel Prize in Physiology or Medicine 2021. ACD440 is developed for local treatment as a gel and has previously been studied in a clinical phase Ib study, which showed both good tolerability and good pain-relieving effect.

Read more: The Nobel Prize 2021: Unlocking the door to a complex sense

”This shows that AlzeCure continues to deliver according to plan,” says Martin Jönsson, CEO of AlzeCure Pharma. ”Neuropathic pain is an area that is in great need of new, more effective and safer treatments, including alternatives to opioids, and I am very much looking forward to the results of this important study.”

Photo of Martin Jönsson: Jenny Lagerqvist