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 Last Patient Last Visit (LPLV) has now been completed in the ongoing phase II clinical trial with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain.
”We look forward to seeing the results of this important phase II trial in peripheral neuropathic pain, an area of very high medical need where up to 80% of patients are not responding satisfactorily with their current treatments and where many are still prescribed opioids”, said Märta Segerdahl, project leader and CMO at AlzeCure Pharma.
This double-blind, placebo-controlled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Sweden, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure's lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest.
AlzeCure's 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, which is also the company's leading drug candidate within the Painless platform, 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.
The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The neuropathic pain market is the single largest market segment in pain management with annual sales exceeding $11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments.
"The lack of effective and safe drugs, combined with the fact that upwards of 8% of the adult population suffers from neuropathic pain, makes clear the great medical need and the enormous potential of our project. ACD440 can become a first-in-class drug and meet a very large patient need, which of cause is a value driver in connection with the outlicensing of the project", said Martin Jönsson, CEO of AlzeCure Pharma.
