Uppsala Sweden, June 22st
LINK Medical, the Northern European clinical research organization (CRO), and AlzeCure Pharma AB (publ) (FN STO: ALZCUR), announced today that the first patient has been enrolled in the phase II clinical trial for neuropathic pain treated with the non-opioid ACD440.
Alzecure is 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. This is a unique trial leading a non-opioid drug candidate in the painless platform which is being developed for peripheral neuropathic pain.
The regulatory authorities recently approved for the study to start. The Phase II clinical trial is a double-blind, placebo-controlled, randomized cross-over study evaluating the efficacy, safety, and pharmacokinetics of AlzeCure’s leading drug candidate in pain, ACD440. Results from the study are expected in mid-2023.
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 for the project, was awarded the Nobel Prize in Physiology or Medicine in 2021. ACD440, which is applied as a gel, is the company’s leading drug candidate in the Painless platform and Alzecure conducted a positive phase Ib study in 2021.
The medical need in neuropathic pain is great, not least to find alternatives to opioids. The market for neuropathic pain is the single largest market segment in pain treatment, with annual sales of over USD 11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments.
“We are very pleased to have been able to initiate this important study with ACD440 according to plan,” said Märta Segerdahl, project manager 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 neuropathic pain.”
“This is a big step for both the project and the company, as we are now a phase II company. With the previous positive results from the phase Ib study, we look forward to the reading of this study, which can generate even greater interest in our licensing,” said Martin Jönsson, CEO of AlzeCure Pharma.
“We are delighted to work with AlzeCure Pharma and be their trusted strategic partner. The present groundbreaking study has the obvious potential to improve the treatment for neuropathic pain through a novel mechanism of action. We are also happy to introduce the decentralized approach into this project which will make the process easier, faster, and most efficient for all stakeholders.” – said Ola Gudmundsen, CEO of LINK Medical