MAC Clinical Research is proud to announce the successful completion of the single ascending dose (SAD) phase of the first-in-human (FIH) clinical trial for KP405, Kariya Pharmaceuticals’ pioneering drug candidate for Parkinson’s disease.
This study marks a significant advancement in the development of KP405, a brain-penetrant dual incretin (GLP-1/GIP) receptor agonist that aims to slow the progression of Parkinson’s disease.
Dr. John Connell, Chief Scientific Officer at MAC Clinical Research, expressed his enthusiasm for the milestone: “We are thrilled with the successful completion of the SAD phase of the KP405 study. These results underline the strength of our partnership with Kariya Pharmaceuticals and our shared commitment to advancing therapies for neurodegenerative diseases. This achievement sets the stage for further exploration of KP405’s potential to change the treatment landscape for Parkinson’s disease.”
The SAD phase was conducted at MAC’s MHRA-accredited site in Manchester, UK. The study enrolled 48 participants across six cohorts, evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered KP405 in healthy volunteers. The completion of this phase without safety concerns or premature discontinuations highlights the promising safety profile of KP405 and its potential to be the first-to-market treatment in its drug class.
KP405 demonstrated pharmacological effects consistent with the incretin drug class, further reinforcing its potential as a groundbreaking therapeutic option for patients with Parkinson’s disease. The focus now shifts to the multiple ascending dose (MAD) phase of the trial, scheduled to commence early in the new year.
With a legacy of excellence in central nervous system (CNS) research, MAC Clinical Research has established itself as a leader in neurodegenerative disease studies. Over the past five years, 72% of our clinical trials have focused on CNS therapeutic areas, including seven studies specifically targeting Parkinson’s disease.
The successful completion of the KP405 SAD study underscores MAC’s ability to support innovative drug development programs and make meaningful contributions to advancing treatments for complex conditions such as Parkinson’s disease.
We are proud to collaborate with Kariya Pharmaceuticals on this groundbreaking journey and look forward to continuing our work together to bring transformative treatments to those living with Parkinson’s disease.
Read the statement issued by Kariya Pharmaceuticals here.
