The full title of the application 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.”
PN6047 is a first-in-class small molecule that selectively activates the delta opioid receptor (DOR), avoiding interaction with the mu opioid receptor, which is the basis of the addiction and other unwanted effects associated with conventional opioids.
It is designed to enable safe and effective dosing to deliver clinical proof of concept (POC) in a Phase IIa study of patients with peripheral neuropathic pain.
Based on a strategic company decision, PharmNovo has 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 following approval in Spain, which is expected by October 2025.
Subject to additional investment, patient enrolment is expected to start by Quarter 1 2026.
Although the study will be run in the EU, it is fully aligned with the FDA requirements defined during a pre-IND (Investigational New Drug) meeting in January 2025. Full IND submission is planned for the second half of 2025.
Per von Mentzer, CEO of PharmNovo, says: “We have reached an important milestone in the company’s development and I am very proud of the PharmNovo team for their excellent work in preparing the huge amount of documentation required for the CTA regulatory submission."
"PN6047 offers new hope for the future of neuropathic pain management by enabling a fundamental shift toward safer non-addictive treatments that can redefine care standards.”
