PharmNovo completes drug product manufacturing for Phase IIa study of PN6047

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.

PharmNovo is a clinical-stage pharmaceutical company focused on developing safe and effective drugs for neuropathic pain, an area with significant unmet medical need. The company’s lead candidate, PN6047, is a potential first-in-class DORA (Delta Opioid Receptor Agonist) and represents a safer and non-addictive treatment for neuropathic pain.

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.

Per von Mentzer, CEO of PharmNovo says: “We have reached an important milestone with the development of PN6047 by manufacturing the drug product for the Phase IIa study, planned to start in Q4 2026. PN6047 offers new hope for the future of neuropathic pain management, with the potential to enable a fundamental shift towards safer non-addictive treatments.”

The manufacturing of the drug product represents an important step in the company’s preparations for the Phase IIa study and continued clinical development of PN6047. The company is now progressing towards the next stage of its clinical program, with a focus on generating clinical data to support continued development and future partnering.