The Malmö based “micro-pharma” aiming at developing innovative new approaches to treat diabetes, PILA PHARMA has acquired XEN-D0501, a clinical ready and safe TRPV1 antagonist development candidate, previously owned by Ario Pharma.
The acquired asset include a series of small molecule TRPV1 antagonists including the clinical ready and safe development candidate XEN-D0501, patents, know-how and data.
The TRPV1 target (also called the “chili-receptor”) has been shown to have applications across pain and inflammatory diseases and is speculated to have a role in diabetes as well.
After oral delivery, “target-interaction” (blockade of the “chili-receptor”) has been demonstrated in man and in vivo efficacy in regulating blood glucose has been demonstrated in diabetic mice, together suggesting that this compound could have the potential to be effective in human diabetes after oral delivery.
PILA PHARMA is planning to undertake a fast-track clinical development program, assessing the efficacy and safety of XEN-D0501 in treatment of type 2 diabetes.
There is a significant unmet need to provide an orally available therapeutic for diabetes, which not only offers the regulation of blood glucose but that also addresses the co-morbidities of diabetes – elevated blood lipids and increased bodyweight that are associated with an increased risk of cardiovascular disease. In preclinical models of diabetes, TRPV1 antagonists have been shown to correct both insulin secretion as well as insulin sensitivity and be effective regulators of blood glucose and blood lipids.
The target product profile of PILA PHARMAs anti-diabetic TRPV1 antagonists is to effectively reduce blood glucose to near-normal levels via a dual regulation of insulin secretion and insulin sensitivity as well as regulating blood lipids and bodyweight thereby eventually reducing the overall risk of cardio-vascular disease”.
“I am very pleased to have reached an agreement with Ario Pharma regarding this valuable asset. The acquisition of especially XEND0501 permits us to move straight to clinical safety and efficacy trials in type 2 diabetic patients. I’m thrilled that we are so close to know if the hypothesis of regulating diabetes with blockers of the “chili-receptor”, TRPV1, that I put forward almost 15 years ago will be valid,” said Dorte X. Gram, CEO of PILA PHARMA.