Swedish biotech PharmNovo has submitted a clinical trial application (CTA) to Spanish health authorities for its lead candidate PN6047, marking a significant milestone in developing non-addictive alternatives for neuropathic pain management. The selective delta opioid receptor agonist represents a potential breakthrough in addressing the ongoing opioid crisis while providing effective pain relief.
Novel Mechanism Targets Pain Without Addiction Risk
PN6047 is a small molecule that selectively targets the delta opioid receptor, offering pain relief without activating the mu opioid receptor – the primary driver of addiction and other side effects associated with conventional opioids. This selective mechanism is designed to enable safe and effective dosing in patients with peripheral neuropathic pain, addressing a critical unmet medical need in pain management.
The drug candidate is set to be evaluated in a phase 2 trial specifically focused on peripheral neuropathic pain patients. This approach represents a fundamental shift toward safer, non-addictive treatments that could redefine current care standards in pain management.
Regulatory Strategy and Timeline
The initial CTA submission covers Spain, with filings in the Czech Republic and Poland expected upon approval, anticipated by October this year. Patient enrollment is planned to begin in the first quarter of 2026, subject to further investment. The EU-based study has been aligned with US Food and Drug Administration guidance from a pre-Investigational New Drug (IND) meeting earlier this year, with full IND submission anticipated in late 2025.
"We have reached an important milestone in the company's development," said Per von Mentzer, CEO of PharmNovo. "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."
Broader Therapeutic Potential
Beyond neuropathic pain, PharmNovo is exploring PN6047's potential in multiple other indications, including opioid withdrawal syndrome, opioid use disorder, migraine, and chronic cough. This diversified approach could expand the drug's therapeutic impact across several areas of significant medical need.
The company has also submitted a separate CTA to the Swedish Medical Products Agency for a phase I First in Human clinical trial with PN6047. This trial will be conducted at Clinical Trial Consultants AB's facility in Uppsala and is planned to enroll approximately 100 healthy subjects. The phase I submission represents the culmination of several years of dedicated chemistry, manufacturing, and controls work, along with preclinical studies demonstrating the compound's safety profile for human testing.
