The independent Data Monitoring Committee (DMC) has recommended the continuation of Algiax Pharmaceuticals’ Phase IIa study with lead candidate AP-325 in chronic neuropathic pain.
Based on the positive DMC review and confirmed financial commitment from its investors, the company will expand the trial to Belgium, France, and Italy.
The study is continuing as planned with topline efficacy readouts and a more in-depth safety analysis expected at the conclusion in 2024.
AP-325 is a small molecule drug candidate that binds and modulates the GABAA receptor, reducing the excitability of the respective neurons.
Neuropathic pain is a chronic condition that is often associated with an imbalance in excitatory and inhibitory neuronal signals. By consistently counteracting the excessive activation of neurons, signalling can be dampened resulting in reduced levels of pain.
“Current treatment of neuropathic pain is dominated by anti-epileptic medicines, antidepressants, and traditional painkillers, none of which provide any long-term pain alleviation. The burden and reduction in quality of life remains high for these patients, with many of them being unable to work and participate in normal day-to-day activities,” said Claudia Sommer, Professor of Neurology at the University of Würzburg, past President of the International Association for the Study of Pain (IASP) and clinical expert in Algiax’s advisory board.
“Algiax’s AP-325 has a promising profile with a novel mode of action and already demonstrated a long-lasting reduction of neuropathic pain in preclinical studies. The strong safety profile confirmed in the clinic further validates this approach which is critical in the treatment of a chronic condition. I am looking forward to further exploring its potential with the full Phase IIa analysis in 2024.”