Algiax Pharmaceuticals has announced positive topline results from its Phase 2a clinical trial of AP-325, a non-opioid drug for the treatment of neuropathic pain. The study, which enrolled 99 patients across Europe, demonstrated that AP-325 significantly reduced pain and improved quality of life markers in patients with post-surgical neuropathic pain.
The Phase 2a trial was a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of AP-325 as a monotherapy. Participants were treated for 10 days, with follow-up for a further 26 days. The primary endpoint was the change in pain intensity as measured by the Pain Intensity Numeric Rating Scale (PI-NRS).
Key Findings
The trial results indicated a rapid onset of action, with clinically meaningful pain reduction observed within two weeks of treatment. More than 25% of AP-325-treated patients experienced a 50% or greater reduction in pain, compared to 11% in the placebo group. Furthermore, over half of the patients in the AP-325 cohort did not require rescue medication, compared to only 21% in the placebo group.
"These results mark a significant step towards our vision of disarming chronic neuropathic pain and offering a well-tolerated treatment option without the risk of dependence," said Dr. Ingo Lehrke, CEO of Algiax Pharmaceuticals.
Safety and Tolerability
AP-325 demonstrated a good safety profile, with side effects comparable to placebo and no reported central nervous system side effects such as sedation, drowsiness, or dizziness. This is a significant advantage over existing treatments for neuropathic pain, many of which are associated with significant side effects.
Mechanism of Action
AP-325 is an allosteric GABAA-receptor modulator. It aims to reduce pain by activating GABAA signaling, counteracting excessive neuronal activity. Neuropathic pain is often associated with an imbalance in excitatory and inhibitory neuronal signals, and AP-325 seeks to restore this balance.
The Need for New Options
Neuropathic pain is a chronic condition resulting from damage to nervous tissue, affecting millions worldwide. Current treatment options are limited, and many patients do not achieve adequate pain relief. Opioids can provide relief but carry a risk of dependency, making non-opioid alternatives highly desirable.
"With a lack of non-opioid treatment options for chronic neuropathic pain, there is a remaining high need for millions of patients worldwide," noted Dr. Guido Koopmans, CSO of Algiax Pharmaceuticals. "The clinical meaningful effects in our Phase 2a study, combined with the clean safety profile, in particular regarding central nervous system side effects seen with standard of care, underline AP-325’s unique potential to provide a paradigm shift in neuropathic pain management for patients."
Future Directions
Algiax Pharmaceuticals is now exploring opportunities to support the rapid advancement of AP-325's clinical development. The company aims to further explore the potential of GABAA modulation through its proprietary Thioacrylamide (ThAc) derivatives as follow-up candidates for neuropathic pain.
