AlzeCure announces positive Phase IIa clinical study data in neuropathic pain with the non-opioid ACD440

AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of small molecule candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the company has received positive data from the Phase IIa clinical study with the non-opioid drug candidate ACD440, which is developed against peripheral neuropathic pain.

  • The phase II data show that ACD440 was able to demonstrate positive proof-of-mechanism (PoM) results in patients with chronic peripheral neuropathic pain, i.e. the drug candidate has an effect on the intended target mechanism.
  • A significant analgesic effect was observed on pain induced by cold and heat. This temperature hypersensitivity is very common in the skin area, where the patients have their neuropathic pain, and is a major problem in everyday life for these individuals.
  • These positive phase II results are in line with previously reported Phase I results.
  • ACD440 was well tolerated as a topical gel on the skin, which shows good suitability for continued clinical development, i.e. as a local treatment against neuropathic pain conditions.

”We are very pleased that in this pilot study, ACD440 was both well tolerated and able to demonstrate a good effect on the common factors that patients with peripheral neuropathic pain often experience as painful,” said Märta Segerdahl, project leader and CMO at AlzeCure Pharma. "Neuropathic pain is an area of great medical need, and we believe that ACD440 could significantly improve the quality of life for patients suffering from this type of pain."

The Phase II clinical study, which was initiated in June 2022 and is being conducted in collaboration with LINK Medical Research, is a double-blind, placebo-controlled, randomized cross-over study to evaluate the efficacy and safety of AlzeCure's lead drug candidate in pain, ACD440.

"The medical need in this area is immense, not least to find alternatives to opioids. Neuropathic pain is the single largest market segment in pain management, generating over $11 billion in annual revenues. Up to 80 percent of all patients do not get a satisfactory effect with their current treatments," said AlzeCure Pharma’s CEO Martin Jönsson. "These new clinical data will help us increase interest in a license agreement with ACD440."

ACD440 is a TRPV1 antagonist and first-in-class local treatment for patients with peripheral neuropathic pain. The discovery of TRPV1, which is the basis of the project, was awarded the Nobel Prize in Physiology or Medicine 2021. ACD440, which is applied as a gel, is the company’s leading drug candidate within the Painless platform and completed a positive phase Ib study in 2021.