AlzeCure Pharma has announced that the first patient has been included in a Phase II clinical trial with ACD440, a non-opioid drug candidate in the Painless platform which is being developed for peripheral neuropathic pain.
This follows the recent approvals from regulatory authorities to begin the study.
“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 outlicensing,” says Martin Jönsson, CEO of AlzeCure Pharma.
The Phase II clinical trial
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 conducted a positive phase Ib study in 2021.
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“We are very pleased to have been able to initiate this important study with ACD440 according to plan,” says 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.”
Photo of Martin Jönsson: Jenny Lagerqvist