The study has enrolled participants with chronic post-operative neuropathic pain. Credit: b.asia / Shutterstock.com.

Algiax Pharmaceuticals has broadened its Phase IIa clinical trial of AP-325, a treatment for chronic neuropathic pain, to include 12 additional sites in Belgium and France.

This expansion follows positive mid-enrolment interim analysis data and a confirmed financial commitment from the investors of the company.

The randomised, controlled AP-325.04 study now encompasses 25 active sites, including study centres in the Czech Republic and Spain.

Algiax enrolled the first French patients at Roche-sur-Yon and Hôpital Ambroise Paré in Boulogne-Billancourt while the study has enrolled participants with chronic post-operative neuropathic pain at ZOL in Genk and UZ Leuven in Belgium.

AP-325 is a new small molecule that works as a positive allosteric modulator of the GABAA receptor in the dorsal root ganglion (DRG), a target for focal treatment that can restore spinal inhibition and alleviate pain.

Preclinical data has shown AP-325’s dose-dependent, long-lasting efficacy in various pain models, including central and peripheral neuropathic pain, as well as diabetic neuropathy.

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AP-325 has also displayed a favourable safety profile, devoid of central side effects such as drug addiction or dizziness, which are common concerns in pain management.

Algiax Pharmaceuticals CEO Ingo Lehrke said: “We are excited about the progress of our Phase IIa study and the expansion of our study into Belgium and France.

“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.”

In September 2020, Algiax enrolled the first subject in a Phase IIa multicentre proof-of-concept trial of AP-325 for treating chronic neuropathic pain.