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Land | Sverige |
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AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced that a scientific article has been published on the clinical phase IIa results supporting the continued development of the lead drug candidate Painless ACD440.
The article, titled Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces temperature-evoked pain in patients with peripheral neuropathic pain with sensory hypersensitivity, a randomized, double-blind, placebo-controlled, crossover study, has been published online in the Scandinavian Journal of Pain and is written by Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Adriana Miclescu, Rolf Karlsten, Ingrid Lönnstedt, and Magnus Halldin.
The article focuses on the clinical phase IIa study with ACD440 in patients with chronic peripheral neuropathic pain. The results show that ACD440 had significant analgesic effects on temperature-induced pain compared to placebo in patients with various types of nerve pain induced by, e.g., shingles, amputation and side effects of cancer treatment. The effect was significant in this group despite the use of other pain medications in parallel.
The results also showed that the product was very well tolerated as a topical gel on the skin, indicating good suitability for further clinical development, i.e. as a local treatment for nociceptive and neuropathic pain conditions. Furthermore, the results showed that the clinical bedside kit used worked very well to identify patients suitable for treatment.
ACD440 is a first-in-class TRPV1 antagonist in clinical development as a novel topical local treatment for chronic peripheral neuropathic pain. The drug candidate, which was incorporated via a strategic in-licensing, originated in Big Pharma and is based on a strong scientific foundation, which was awarded a Nobel Prize in 2021. The substance is being developed as a gel for topical use, which keeps systemic exposure very low while maintaining high local concentrations of the substance to achieve maximum analgesic effect and over a long period of time.
"The publication demonstrates proof-of-mechanism in patients for ACD440, i.e. that the product has a high and significant analgesic effect. This now strengthens the continued development opportunities for ACD440," said Märta Segerdahl, CMO at AlzeCure Pharma.
“There is a great medical need for effective and safe non-opioid treatments for neuropathic pain. 7-8 out of 10 patients do not experience a satisfactory effect from existing treatment, and the area is the single largest in pain. Our project ACD440 has very great potential," said Martin Jönsson, CEO of AlzeCure Pharma.
The article is now available online via the following link: https://www.degruyterbrill.com/document/doi/10.1515/sjpain-2025-0011/html