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 final Phase I results
The final results from the Phase I clinical for our neuropathic pain drug candidate PN6047, demonstrates safety and tolerability and a lack of the adverse effects commonly associated with conventional opioids. 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.
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Meet Bengt von Mentzer, founder and Chief scientific advisor
Bengt von Mentzer founded PharmNovo 16 years ago, and today, his visionary approach and scientific process still drive the development of the groundbreaking compound PN6047. At the intersection of innovation and scientific leadership, Bengt von Mentzer is paving the way for how to reshape the landscape of chronic pain treatment.
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NIDA funds studies
The US National Institute of Drug Abuse (NIDA) has funded a project investigating the drug candidate PN6047, a novel and highly selective Delta Opioid Receptor Agonist (DORA), represents a unique approach to addressing this medical challenge.
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Meet Olof Breuer, MD, Clinical pharmacology lead
Olof Breuer's presence at PharmNovo exemplifies the company's commitment to pioneering advancements in pain relief. His visionary approach, honed through years of experience, positions him as a driving force in the quest for novel concepts in neuropathic pain relief.
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