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AlzeCure announces Phase IIa clinical study data

AlzeCure Pharma has received positive data from the 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, states the company. 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.

”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.”

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.

The Phase II study

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.”

Photo of Martin Jönsson: AlzeCure/Jenny Lagerqvist