From safety to efficacy
HAVING FINALISED our first in man trials. Our aim is to establish efficacy through Phase IIA Proof of Concept studies in one or more patient populations starting in 2024.
OUR JOURNEY
NEXT: PHASE IIA-READY
Therapeutic focus » The PharmNovo Journey
HAVING FINALISED our first in man trials. Our aim is to establish efficacy through Phase IIA Proof of Concept studies in one or more patient populations starting in 2024.
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 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.
Read moreTake the opportunity to listen to Per von Mentzer, CEO, presenting PN6047 at the LSX World Congress in April 2025 in London. PharmNovo is redefining pain management with PN6047, a first-in-class Delta Opioid Receptor Agonist (DORA), safer, non-addictive solution for neuropathic pain. Unlike traditional opioids, PN6047 eliminates concerns of side effects, abuse potential, and tolerance. With a proven safety profile from Phase I trials and a market projected to exceed EUR 13 billion by 2033, PN6047 is set to be a game-changer.
Read morePharmNovo has received positive and constructive feedback from the FDA for its lead drug candidate, PN6047, a selective delta opioid receptor agonist aimed at treating peripheral neuropathy with allodynia. Following a successful pre-IND meeting in January 2025, the FDA provided valuable guidance on the Phase IIa study design and had no critical comments on the CMC or non-clinical data. This paves the way for IND submission by the end of 2025 and a Phase IIa clinical trial application in Europe (Spain, Poland, Czech Republic) by Q3 2025.
Read morePharmNovo has recently published an article in MedNous, highlighting the pioneering approach to tackling neuropathic pain without the risks traditionally associated with opioids. The lead candidate, PN6047, targets the delta-opioid receptor – offering pain relief without addiction or sedation. Arrangements for a Phase II trial have now been completed, marking a crucial step toward a safer alternative for millions suffering from chronic pain. With the opioid crisis still a major concern, innovative, non-addictive treatments like PN6047 are more urgent than ever.
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