Date: 23-Sep-2020

Algiax Pharma Begins Patient Dosing In Phase IIa CURE Study Of AP-325 To Treat Chronic Neuropathic Pain

Algiax Pharmaceuticals, a clinical-stage biotechnology company focused on development of GABAA receptor modulators for neuropathic pain and other indications with unmet medical need, announced that the first patient has been enrolled in the “CURE” study.

Top-line Data for the “CURE” Study Anticipated in Fourth Quarter 2021

In times of COVID-19, conducting a clinical trial that does not contribute to fighting the pandemic is doubly difficult. Nevertheless, Algiax has succeeded in initiating the “CURE” study of its lead candidate AP-325. This brings the company a further step closer to its goal – the treatment of chronic neuropathic pain without causing serious side-effects on the central nervous system and thus an important approach in the fight against the opiate crisis.

The CURE study is a randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety after repeated oral dosing of Algiax´ lead product AP-325. The subjects had previously been diagnosed with peripheral post-surgical neuropathic pain (PPNP) after breast surgery, chest surgery or groin hernia repair. The aim is to enroll 94 subjects in 13 participating clinical sites in Germany, Spain and the Czech Republic.

Prof. Heike Rittner, head of the pain clinic at the University Hospital of Würzburg said: “As a pain physician I see the burden of chronic pain on a daily basis and new treatment options are desperately needed for these patients. For that reason, I support the clinical development of promising treatments where I can. The CURE study and especially AP-325 is an exciting example of a development program that investigates an innovative treatment targeting a pathway which all currently known analgesics have neglected. As the coordinating investigator of the study I’m really looking forward to start treating the first patients in this study.”

Prof. Claudia Sommer, Professor of Neurology and pain researcher at the University of Würzburg and clinical expert in Algiax` advisory board pointed out: “Chronic pain and especially pain of neuropathic origin is very difficult to treat and the current treatment options are limited. AP-325 is a novel potential treatment option with very exciting pre-clinical and phase I study results. If the primary endpoint of the CURE study is met, this would be great news for all patients and physicians waiting for an efficacious and safe treatment of neuropathic pain.