AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the company's presentation at the pain conference EFIC 2023 is now available in its entirety on the company's website. The presentation contains clinical phase II data with the company's leading clinical candidate drug in pain, Painless ACD440, which is being developed with a focus on neuropathic pain.
”The results from the phase II study with ACD440 showed that the substance reduces temperature-evoked pain by approximately 50%, a significant and clinically relevant reduction. These positive data are in line with the results from the phase Ib study, and with this, we have also demonstrated proof-of-mechanism in patients,” said Märta Segerdahl, MD, PhD, project leader and CMO at AlzeCure.
The presentation, entitled A study of ACD440 gel for the treatment of patients with peripheral neuropathic pain with sensory hypersensitivity, was given by Dr. Märta Segerdahl, project manager and CMO at AlzeCure, and contains results from the phase II clinical study with ACD440, the lead candidate drug in the Painless platform.
The presentation showed the results of the completed phase II clinical trial of ACD440 in patients with peripheral neuropathic pain. The study was a double-blind, placebo-controlled, randomized study aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure's lead candidate drug in pain, ACD440. The patients, who were treated for 7+7 days in a cross over design, were between 50-85 years old and suffered from chronic neuropathic pain. The majority of them also were on existing pain treatment. Data from the study showed a clear and significant effect (p=0.0166) of ACD440 gel on temperature-induced pain in the patients. A very good safety and tolerability of the product in the patients was also observed.
AlzeCure's non-opioid drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440 has previously completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin.
"We are of course very happy about these positive data which show both significant effect and good tolerability. These data support further development of ACD440 and strengthens both the project scientifically and the interest from potential partners. This in an area of huge unmet medical need and an ongoing opioid crisis," said Martin Jönsson, CEO of AlzeCure Pharma.
The poster is available on AlzeCure's website: https://www.alzecurepharma.se/en/presentations-and-interviews/