PharmNovo secures CTA approval in Spain to initiate Phase IIa proof-of-concept trial of PN6047 for neuropathic pain
PN6047 is a first-in-class small molecule that selectively activates the delta opioid receptor (DOR), avoiding interaction with the mu opioid receptor that is the basis of the addiction and other unwanted effects associated with conventional opioids. It is designed to enable safe and effective treatment to deliver clinical proof of concept (POC) in a Phase IIa study of patients with peripheral neuropathic pain.
PharmNovo AB is pleased to announce that the clinical trial application (CTA) for a Phase IIa proof of concept (PoC) study investigating the safety and efficacy of lead candidate PN6047 in patients with neuropathic pain has been approved in Spain. 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.”
Based on a strategic company decision, PharmNovo submitted the CTA, in the first instance, to the Spanish Health Authorities only. Submission to the Czech Republic and Poland, the two other countries in which the trial will be conducted, is planned to take place. Subject to additional investment, patient enrolment is expected to start by mid-2026.
Read the full pressrelease here
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