Last patient included in Phase II clinical trial

Alze­Cure Phar­ma 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 has now been includ­ed in the ongo­ing Phase II clin­i­cal study with ACD440, the lead non-opi­oid drug can­di­date in the Pain­less plat­form, which is being devel­oped against periph­er­al neu­ro­path­ic pain.

This dou­ble-blind, place­bo-con­trolled, ran­dom­ized cross-over study, which is car­ried out in col­lab­o­ra­tion with LINK Med­ical Research in Upp­sala, 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 Dol­lar. Up to 80 per­cent of patients do not get a sat­is­fac­to­ry effect with their cur­rent treatments.

”The study has devel­oped well and the fact that we have now been able to include the last patient in the study means that we have good hopes that the study will also deliv­er the results accord­ing to what we pre­vi­ous­ly com­mu­ni­cat­ed,” said Mär­ta Segerdahl, MD, PhD, project leader and CMO at Alze­Cure. “We see an excit­ing poten­tial with ACD440, where you can broad­en the fur­ther devel­op­ment with oth­er for­mu­la­tions, there­by enabling sev­er­al indications.”

“With the pre­vi­ous pos­i­tive results from the phase Ib study, we look for­ward to the read­out of this phase II study. There is already inter­est in the project and with phase II data, the project can gen­er­ate even greater inter­est for out-licens­ing in a seg­ment with a very high med­ical need,” said Mar­tin Jöns­son, CEO of Alze­Cure Pharma.