PharmNovo successfully completes phase I study with lead candidate PN6047
The Swedish pharmaceutical company PharmNovo is pleased to announce the completion of the phase I study of the drug candidate PN6047 for neuropathic pain. The headline results of the study show that PN6047 is proven safe and tolerable at doses predicted to be effective.
PharmNovo is a clinical-phase pharmaceutical company dedicated to developing safe and effective treatments for neuropathic pain. The company’s lead drug candidate, PN6047, has successfully completed the phase I study, 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.
"We have reached a remarkable milestone with our phase I study, and I am very proud of my team. Our mission to transform neuropathic pain treatment is steadily progressing. Our drug candidate has demonstrated robust tolerability and pharmacokinetics and, most importantly, avoids the common pitfalls associated with conventional opioids. We are on a path to improve lives, and this marks just the beginning of our journey," says Per von Mentzer, CEO of PharmNovo.
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.
In August 2022, PharmNovo initiated the First-In-Human (FIH) clinical study for 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.
"Regarding the development of PN6047, our track record stands on par with top players in the pharma industry. We have successfully completed both the preclinical and phase I stages, each within a year, with highly satisfactory results," says Jesper Kjerulff, COO at PharmNovo.
PharmNovo is currently in the preparatory stages to initiate the phase II development of PN6047, with the aim of treating the first neuropathic pain patient by mid-2024, using a dosage level expected to be effective.
For more information, please contact:
Per von Mentzer, CEO
Phone +46 705 44 32 50
Email: per.von.mentzer@pharmnovo.com
About PharmNovo
PharmNovo AB is a clinical-stage pharmaceutical company focused on developing safe and effective drugs for neuropathic pain. In this area, there is currently a lack of sufficient treatments. The company's drug candidate, PN6047, effectively reduces neuropathic pain in animal models. The company also sees clinical potential in other areas: chronic cough and opioid withdrawal syndrome (OWS). PharmNovo, headquartered in Medicon Village in Lund, Sweden, was founded in 2008 by Dr. Bengt von Mentzer, who has more than 30 years of experience in drug development and pain research at AstraZeneca. The team comprises prominent researchers in academia and industry, and the company has an extensive international network of leading expert advisors. To learn more, visit pharmnovo.com and follow PharmNovo at LinkedIn.
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