Based on last year's positive mid-enrollment interim analysis and confirmed financial commitment from its investors, the company is pleased to announce the initiation of 12 new clinical sites in Belgium and France as part of its Phase 2a Randomized Controlled Trial (RCT) - AP-325.04 study. With these additions, the total number of active sites in the study has reached 25, including sites in the Czech Republic and Spain.
The expansion of our clinical trial into Belgium and France marks a significant milestone in our commitment to advancing pain management research and providing effective treatments for patients suffering from chronic neuropathic pain conditions. We are delighted to report the enrollment of the first French patients at the esteemed sites of Prof. Pluchon in Roche-sur-Yon and Prof. Attal at the Hôpital Ambroise Paré, Boulogne-Billancourt.
In Belgium, our study has successfully enrolled patients with chronic post-operative neuropathic pain at the sites of Dr. van Boxem at ZOL in Genk and Prof. Morlion at UZ Leuven. This achievement underscores our dedication to collaborating with leading clinicians and researchers to bring innovative therapies to those in need.
"We are excited about the progress of our Phase 2a study and the expansion of our study into Belgium and France," said Ingo Lehrke, Ph.D., Chief Executive Officer of Algiax Pharmaceuticals. "The addition of these new clinical sites further strengthens our efforts to present topline efficacy readouts and an in-depth safety analysis following study conclusion in Q4 2024."
About AP-325:
AP-325 is a unique small molecule designed to act as a positive allosteric modulator of the GABAA receptor in the dorsal root ganglion (DRG). The DRG is susceptible to focal treatment with GABAA modulators, allowing AP-325 to restore spinal inhibition and reduce pain. In its preclinical evaluation, AP-325 demonstrated dose-dependent, long-lasting efficacy on mechanical and thermal pain reception in models of central neuropathic pain, peripheral neuropathic pain, and diabetic neuropathy. Furthermore, AP-325 demonstrated a favorable safety profile with no signs of central side effects like drug addiction or dizziness.
About Algiax:
Algiax Pharmaceuticals is dedicated to providing better long-lasting treatment options for neuropathic pain alleviating the burden of this chronic condition by modulating GABAA signaling. Its lead small-molecule candidate AP-325 is currently being investigated in a Phase 2 study and has already demonstrated promising disease modification in preclinical studies as well as a good safety profile in early clinical evaluation. The company aims to further explore the potential of GABAA modulation through its proprietary Thioacrylamide (ThAc) derivatives for the treatment of other chronic diseases including diabetes.
