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 dosing to deliver clinical proof of concept (POC) in a Phase IIa study of patients with peripheral neuropathic pain.
PharmNovo AB announced 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 submitted in Spain.
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.’
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 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.”
PharmNovo AB is a clinical-stage pharmaceutical company focused on developing safe and effective drugs for neuropathic pain. In this area, there is currently a lack of efficacious and safe treatments. The company has developed a portfolio of novel compounds based on a new generation of selective delta opioid receptor agonists (DORAs), intended to provide effective neuropathic pain relief without the adverse side effects of conventional opioids.
The company’s lead candidate, PN6047 has been shown to effectively reduce neuropathic pain in preclinical studies. In addition to the Phase IIa PoC study in neuropathic pain currently being prepared, PharmNovo is planning for Phase IIa PoC studies with the lead candidate across several additional indications such as OWS (opioid withdrawal syndrome) / OUD (opioid use disorder), migraine, and chronic cough. PN6047 has the potential to combat the global opioid crisis.
