Algiax non-opioid drug works in chronic neuropathic pain

A painkiller developed by Germany's Algiax Pharma has shown efficacy in the treatment of chronic neuropathic pain, another positive development in the search for alternatives to opioids.
The phase 2a trial showed rapid onset as well as long-lasting pain reduction with Algiax's allosteric GABAA-receptor modulator AP-325, setting up further trials of the drug.
Neuropathic pain can occur after severe injuries and as a by-product of surgery or diseases like diabetes, shingles, and cancer. It can be very severe and resistant to standard pain medications and, while opioids can provide relief, their tendency to cause dependency means they have to be used sparingly.
The hope is that a new generation of non-opioid analgesics will become available to treat both acute and chronic pain and have a reduced risk of addiction. In 2023, more than 100,000 lives were lost in the US due to opioid overdoses.
Algiax's candidate offers a new potential mechanism of action for pain relief, and is thought to work by correcting excessive activation of pain-transmitting neurons.
In the 99-subject phase 2a trial, which compared AP-325 to placebo in people with post-surgical neuropathic pain, the drug achieved a significant and "clinically meaningful" reduction in the Pain Intensity Numeric Rating Scale (PI-NRS) less than two weeks after starting treatment
At the end of study – which came after a 10-day treatment period with follow-up for a further 26 days – more than 25% of the AP-325 treated patients showed a pain reduction of at least 50%, compared to 11% of the placebo group.
The need for rescue medications for breakthrough pain was also reduced, with around half of the patients on the drug needing none at all compared to 21% of the control group.
At the same time, there were no central nervous system side effects – such as sedation, drowsiness, or dizziness – and AP-325 had a placebo-like safety profile, according to Algiax.
The encouraging result comes just days after the US FDA approved Vertex Pharma's non-opioid painkiller Journavx (suzetrigine), an oral NaV1.8 inhibitor, as a treatment for acute pain, representing the first new class of pain medicine in the US in more than two decades.
Journavx is also being developed for chronic neuropathic pain indications, but a recently reported trial in lumbosacral radiculopathy, a form of lower back pain, disappointed investors and led to a sell-off in its shares.
Armed with its new data, Algiax is "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," said the Dusseldorf-based company's chief executive, Dr Ingo Lehrke.
Image by Tracy Lundgren from Pixabay