Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
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Positive FDA feedback for PN6047
PharmNovo 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.
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Pioneering approach to treat neuropathic pain
PharmNovo 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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PharmNovo live at neurology theme event at RedEye
Per von Mentzer, CEO, presented PN6047 at the Neurology Event at RedEye on October 23. Take the opportunity to listen to a very interesting live presentation and learn more about PN6047, the unique first-in-class phase II ready asset with break-through potential in treatment of neuropathic pain. PN6047 demonstrates safety and tolerability and a lack of the adverse effects commonly associated with conventional opioids. These findings suggest a promising path forward in the field of pain management.
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PharmNovo at the LSX Nordic Congress
PharmNovo attended the LSX Nordic Congress in Copenhagen 8-9 October and Per von Mentzer, CEO presented PN6047, a unique first-in-class phase II ready asset with break-through potential in treatment of neuropathic pain. Being one of 68 companies that have recently been awarded by EIC for up to 17.5 MEUR (2.5 MEUR grant and up to 15 MEUR equity) from a total of 969 applicants is a strong validation of the potential of the phase II ready asset PN6047 and of PharmNovo. Take the opportunity to listen to the presentation here:
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