PN6047 / PharmNovo - LARVOL DELTA

PN6047 Demonstrates Broad Preclinical Efficacy in Headache Models as a Novel Delta-Opioid Receptor Agonist. (PubMed, bioRxiv) - "C57BL6/J mice were used to examine the effects of PN6047 in the following migraine models: chronic intermittent nitroglycerin (NTG)-induced migraine-associated pain, PTH, KCl-induced cortical spreading depression (CSD), and optogenetic evoked CSD in a freely behaving transgenic mice expressing ChR2-eYFP. In addition, we tested whether chronic PN6047 induced MOH and whether it could prevent the development of MOH induced by sumatriptan...Importantly, prolonged PN6047 treatment did not induce MOH or analgesic tolerance. Together, these data demonstrate that despite the distinct mechanisms underlying migraine and headache disorder, PN6047 exhibits robust efficacy without inducing MOH, and displays a favorable safety and tolerability profile."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Migraine • Neuralgia • Pain • Psychiatry

PharmNovo AB announces that the drug product for its lead candidate PN6047 has been manufactured for the upcoming Phase IIa proof-of-concept (PoC) study in neuropathic pain. (Cision) - "The Phase IIa study will investigate the safety and efficacy of PN6047 in patients with neuropathic pain. The clinical trial application (CTA) has previously been submitted in Spain and submissions in Poland and the Czech Republic will follow shortly. The full title of the study is: 'Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia.' Although the study will be conducted in the EU, it is aligned with FDA requirements following a pre-IND (Investigational New Drug) meeting with the FDA, and an IND is currently being compiled."

Clinical • Trial status • CNS Disorders • Pain

Karolinska Development's portfolio company PharmNovo receives approval to initiate a phase 2a trial of its drug candidate PN6047 in Spain (GlobeNewswire) - "The trial will be initiated in Spain, but PharmNovo plans to also submit applications to expand the study to Czech Republic and Poland. Provided that the necessary funding for the implementation of the study is secured, patient enrolment is expected to start by mid-2026."

New P2a trial • Pain