- Allosteric GABAA-receptor modulator AP-325 showed rapid onset as well as long-lasting pain reduction in patients with chronic neuropathic pain in Phase 2a study
- Data confirm previously reported good safety and tolerability with comparable side effects profile as placebo and no central symptoms like sedation, drowsiness and dizziness
- Treatment further improved key quality of life markers including sleep interference, anxiety and depression symptoms
- Company to explore opportunities to support rapid advancement of AP-325’s clinical development
Düsseldorf, GERMANY – February 04, 2025 – Algiax Pharmaceuticals, a clinical-stage biotech company focused on developing innovative treatments for chronic neuropathic pain, today announced compelling topline data from its Phase 2a clinical trial evaluating AP-325 for the treatment of neuropathic pain. The study demonstrated that the company’s lead candidate has the potential to rapidly reduce neuropathic pain as well as achieve long-lasting benefits for patients post treatment. AP-325 is a non-opioid small molecule aimed at reducing neuropathic pain by activating GABAA signalling. Neuropathic pain is a chronic condition that is oftentimes associated with an imbalance in excitatory and inhibitory neuronal signals. By consistently counteracting the excessive activation of neurons, AP-325 has the potential to revolutionize neuropathic pain management.
“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 to patients suffering from this debilitating condition “, commented Dr. Ingo Lehrke, CEO of Algiax Pharmaceuticals. “Based on these highly encouraging results, we are exploring the best path forward to rapidly deliver the benefits of AP-325 to patients suffering from chronic pain worldwide and improve their quality of life.”
Key findings from the Phase 2a study with AP-325 include:
- Rapid onset of action resulting in clinically meaningful pain reduction in Pain Intensity Numeric Rating Scale (PI-NRS) within less than two weeks of treatment
- Treatment effects remained persistent after initial treatment period, suggesting a potential lasting disease modification
- High responder rate: the ≥50% and ≥70% patient responder rates were significantly higher compared to placebo with AP-325 treatment. At the end of study, over a quarter of the AP-325 treated patients showed a pain reduction of ≥50% compared to 11% of the placebo treated patients.
- More than half of patients in the AP-325 cohort did not need to use rescue medication compared to only 21% in the placebo group
- Number needed to treat (NNT) for AP-325, a key measure to analyze treatment success, compares favourably to current standard of care and demonstrates AP-325 achieves similar outcomes as opioid-based drugs without the associated safety concerns
- Significant improvement in sleep quality and reduction in anxiety and depression scores
- Good safety profile with observed side effects comparable to placebo and no central side effects including sedation, drowsiness or dizziness
Dr. Guido Koopmans, CSO of Algiax Pharmaceuticals, added, “With a lack of non-opioid treatment options for chronic neuropathic pain, there is a remaining high need for millions of patients worldwide. 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.”
The Phase 2a randomized, double-blinded, placebo-controlled trial evaluated the safety and efficacy of AP-325 as a monotherapy in patients with peripheral post-surgical neuropathic pain. The study enrolled 99 participants in Germany, Spain, the Czech Republic, Belgium, and France at a total of 27 sites.
