New Study: Positive Clinical Results for Painless ACD440 in Neuropathic Pain

AlzeCure Pharma, based in Stockholm, Sweden, announced the publication of a scientific article detailing the clinical phase Ib results for its lead drug candidate, Painless ACD440. The study, titled "Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces evoked pain in healthy volunteers, a randomized, double-blind, placebo-controlled, crossover study," was published in the European Journal of Pain. The article's primary author is Märta Segerdahl, MD, PhD, and Chief Medical Officer at AlzeCure Pharma, with co-authors Magnus Halldin, Matthias Rother, Traian Popescu, and Klaus Schaffler.

The study highlights the efficacy of ACD440, a first-in-class TRPV1 antagonist developed for topical use, in reducing pain. Results showed significant analgesic effects of ACD440 on laser-induced pain compared to a placebo. This was evident both in the subjective pain ratings provided by the participants and in measured pain-related brain activity. Additionally, notable effects on mechanical pain sensitivity were observed. The analgesic effects of the gel persisted for at least nine hours, and the treatment was well tolerated, suggesting it is suitable for further development as a local treatment for nociceptive and neuropathic pain conditions.

ACD440 originated from a strategic in-licensing from Big Pharma and is based on Nobel Prize-winning science from 2021. As a gel, it maintains low systemic exposure while achieving high local concentrations for maximum analgesic effect over an extended period.

According to Märta Segerdahl, the publication confirms the mechanism of action for ACD440, demonstrating significant pain-relieving effects. Combined with Phase IIa clinical data in chronic patients with peripheral neuropathic pain, this supports the drug's further development. Martin Jönsson, CEO of AlzeCure Pharma, emphasized the substantial unmet medical need for effective, non-opioid treatments for neuropathic pain, noting that 70-80% of patients do not find satisfactory relief with current treatments.

AlzeCure Pharma is a Swedish pharmaceutical company focused on developing innovative treatments for diseases affecting the central nervous system, such as Alzheimer's disease and pain. The company, listed on Nasdaq First North Premier Growth Market, operates three research platforms: NeuroRestore®, Alzstatin®, and Painless. NeuroRestore® includes symptomatic drug candidates targeting multiple indications like Alzheimer's disease, traumatic brain injury, sleep apnea, and Parkinson's disease. The Alzstatin® platform aims to develop disease-modifying and preventive treatments for early Alzheimer's disease and includes two drug candidates.

The Painless platform encompasses two projects: ACD440 and TrkA-NAM. ACD440 is in the clinical development phase for treating neuropathic pain, while TrkA-NAM targets severe pain conditions such as osteoarthritis. AlzeCure aims to advance its projects through preclinical research and early clinical phases while seeking out-licensing opportunities with other pharmaceutical companies.

Neuropathic pain affects around 7-8% of the global adult population, translating to approximately 600 million individuals. This condition often results from nerve damage due to various causes like toxic, traumatic, or metabolic factors. Symptoms include painful tingling, burning sensations, and electric shock-like pains. Many patients also experience allodynia and hyperalgesia. The current treatments for neuropathic pain are often inadequate, with 70-80% of patients not achieving effective pain relief. Due to the risk of abuse and overdose, there is a strong need for non-opioid treatments.

The global market for neuropathic pain was valued at $11 billion in 2020 and is projected to grow to $25 billion by 2027. The patient population is expected to increase due to demographic changes, such as an aging population and more long-term cancer survivors, along with the rising prevalence of type-2 diabetes.