The FDA has agreed on key components of the planned first-in-human study for a drug to treat arterial stiffness
Kaydence Pharma is ready to go ahead with a planned first-in-human (FIH) study for MQ7, its novel drug candidate for the treatment of arterial stiffness.
The US company said following an informative meeting with the US Food and Drug Administration (FDA) it agreed on the key components of the investigational new drug (IND) application and the clinical and regulatory pathway for MQ7. The FDA granted non-clinical requirements.
Kaydence MQ7 has been designed for the treatment of arterial stiffness in stable renal transplant recipients with subclinical vitamin K deficiency.
"We also achieved alignment on key components of the design for the FIH study, including the ability to conduct the study in the target patient population," said Dan Rosenbaum, Kaydence CEO.
Rosenbaum said the FDA "provided input and guidance on our clinical and regulatory development pathway".
Both Kaydence and the US agency will meet again upon completion of the FIH study "to continue discussions regarding the Phase 2 and Phase 3 development programs," Rosenbaum enthused.
For Kaydence, this is a milestone for the industry as currently there are no FDA approved treatments for arterial stiffness, a condition that is highly prevalent in patients with chronic kidney disease/renal transplant.
"Arterial stiffness is associated with decreased renal allograft function and increased risk for cardiovascular morbidity and mortality in renal transplant recipients," the company explained.
Commenting on its drug candidate, Kaydence explained that MQ7 is a pharmaceutical formulation of the vitamin K2 subtype menaquinone 7 and that it enables the activation of a potent, local inhibitor of vascular calcification, matrix Gla protein (MGP), by inhibiting arterial stiffness.
A substantial proportion of patients with chronic kidney disease, including those with renal transplant, do not have sufficient levels of vitamin K (subclinical vitamin K insufficiency) to allow the activation of MGP such that vascular calcification can be inhibited.
In general, inactive MGP is associated with reduced kidney function and increased risk for cardiovascular morbidity and mortality. Further, subclinical vitamin K insufficiency has been associated with reduced allograft function, graft failure, and all-cause mortality in renal transplant recipients.
The news is aligned with recent findings supporting the Matrix Gla Protein status and aortic stiffness as factors for other diseases in a similar manner.
Headquartered in New Jersey, US, Kaydence is a development stage pharmaceutical company and focuses on MQ7 for conditions associated with arterial stiffness in patients with subclinical vitamin K deficiency.