MAC Clinical Research is delighted to announce that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved amendments to the Clinical Trial Application (CTA) for KP405, a pioneering Parkinson’s disease treatment developed by our partner, Kariya Pharmaceuticals. This approval paves the way for the second part of our Phase I study, focusing on Multiple Ascending Dosing (MAD) in healthy volunteers, healthy elderly participants and patients with Parkinson’s disease.
KP405 is a first-in-class, brain-penetrant, dual-incretin receptor agonist designed to slow the progression of Parkinson’s disease. Following the successful completion of the Single Ascending Dose (SAD) phase, the MHRA’s approval allows for critical advancements in the MAD study, including:
- Dose Selection and Escalation: Refining dosing parameters to ensure optimal safety and efficacy profiles
- Innovative Biomarker Study: Incorporating a neuronal exosome biomarker study to enhance our understanding of KP405’s impact on disease progression
The SAD phase, conducted at MAC’s MHRA-accredited site in Manchester, UK, involved 48 participants across six cohorts and demonstrated a promising safety profile for KP405. The successful completion of this phase underscores the strength of our collaboration with Kariya Pharmaceuticals and our shared commitment to advancing therapies for neurodegenerative diseases.
Dr. John Connell, Chief Scientific Officer at MAC Clinical Research, expressed his enthusiasm:
“We are proud to continue our collaboration with Kariya Pharmaceuticals in advancing the development of KP405, a potentially groundbreaking treatment for Parkinson’s disease. The successful completion of the SAD study was an important milestone, and with the approval to proceed with the MAD phase, we are now one step closer to understanding the full potential of this innovative therapy. At MAC, we are committed to conducting high-quality research that drives real progress in neurodegenerative disease treatment, and we look forward to seeing the impact of this next phase of the study.”
Read the statement issued by Kariya Pharmaceuticals here.
