Swedish pharmaceutical company PharmNovo has announced the positive final results from the Phase I trial of its neuropathic pain drug candidate, PN6047. This trial demonstrates the safety and tolerability of PN6047, underscoring its potential as an innovative option in pain management, the company says.
PharmNovo, a clinical-stage pharmaceutical company, focuses on the development of safe and effective treatments for neuropathic pain. The findings from the Phase I trial show that PN6047 is safe and well-tolerated at the doses tested, with no serious adverse events reported.
Furthermore, PN6047 was completely devoid of adverse events typically associated with conventional opioids like oxycodone and morphine, such as respiratory depression, constipation, itching, or untoward effects following withdrawal symptoms. This validates the unique preclinical profile of PN6047, which shows that it acts very selectively on the delta opioid receptor, distinguishing it fundamentally from conventional opioids that target the mu opioid receptor.
Notably, the study’s pharmacokinetic analysis demonstrated that PN6047 achieves plasma levels predicted to be effective for pain relief in humans. This confirms the drug’s potential for effective pain management and supports the development of a flexible dosing regimen in future studies.
“The Phase I results for PN6047 are very encouraging,” said Per von Mentzer, CEO of PharmNovo. “Without the adverse effects common to conventional opioids, PN6047 redefines what an opioid can be. Its unique action, being highly selective for the delta opioid receptor and not interacting with the mu-opioid receptor–the main source of adverse effects in conventional opioids–underscores a safer approach to pain management. This positions PN6047 as a potential pivotal treatment in neuropathic pain, ready to advance to the next stages of development.”
The unique approach of PN6047, targeting the delta opioid receptor and selectively engaging a novel biochemical mechanism of action, represents a significant advance in pain management. This combination of properties minimises the risk of common opioid-related side effects and signals a shift towards a new class of analgesics designed with patient safety and efficacy in mind.
With the Phase I trial’s final report at hand and after fruitful discussions with clinical Key Opinion Leaders on designing the Phase IIa Proof of Concept study, PharmNovo is well-prepared to move PN6047 into the next stages of clinical testing.
