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Regulatory approval for PILA PHARMA’s clinical trial application


PILA PHARMA has received regulatory approval of its first clinical trial application thus permitting the company to move its clinical development candidate, XEN-D0501, into a safety trial in type 2 diabetic patients.

“I am very excited about finally being at the point where we can progress a TRPV1 antagonist into diabetic patients!”, says Dorte X. Gram, founder and CEO of PILA PHARMA. “It is nearly 17 years since I formulated the hypothesis that inhibitors of the TRPV1 (a.k.a. the “chili-receptor”) could be novel pharmacologic tools for the treatment of obesity and obesity-related diseases and disorders. Today, PILA PHARMA has use-patents that give us the exclusive right to treat obesity and diabetes with TRPV1 receptor antagonists and we are now very close to test the first development candidate, XEN-D0501, in diabetic patients.”

The first step will be to assess the safety of the molecule following a single-dose in diabetic patients. If successful, it can progress to multiple-dose efficacy trials to test the effect in diabetics later this year.

During the last year PILA PHARMA has been working closely together with professor Henning Beck-Nielsen’s clinical team at Odense University Hospital in Denmark, to prepare for the clinical trial.

“Henning was the first to suggest that we should test the concept in man, but no clinical-ready TRPV1 antagonists were available at that time. Henning is one of the academic “heavyweights” in diabetes, so I am extremely grateful that Henning still supported the project, when I called to ask for his help more than 10 years later, when antagonists were potentially available”, says Dorte X. Gram.

With Henning Beck-Nielsen back in the project, the plan for moving rapidly towards clinical proof of concept with a clinical ready substance was created and a pilot phase 2 protocol was suggested by Henning Beck-Nielsen.

“We still follow that plan, but due to regulatory requirements, a single-dose safety study was inserted in the plan and is now being initiated. As soon as possible, thereafter, we will conduct the pilot phase 2 originally designed by Henning”, says Dorte X. Gram.

A new Chairman of the Board

The company has also appointed attorney Erik Nerpin as new Chairman of the Board. He has 25 years of experience in corporate finance and M&A, including high profile transactions such as Pfizer’s acquisition of Pharmacia, where he advised Pfizer. For many years, he has been advisor to the Lundin Group of companies, including Lundin Petroleum and Lundin Mining. He has also long experience of board work in pharmaceutical companies, being currently Chairman of Kancera and Diamyd Medical.

“Over the years, I have advised numerous early stage pharmaceutical companies. Many of them have, as expected in this business, failed but some of them have actually made it, such as Alligator Bioscience, CellaVision and Hansa Medical, today all successful companies listed on Nasdaq in Stockholm. It is an honor for me to enter the board as new Chairman and I am convinced that PILA PHAMA will grow into something really big in the near future”, comments Erik Nerpin. “I am extremely impressed by Dorte X. Gram as founder and CEO. Being a football fan, I believe everybody who knows football will understand when I call Dorte X. Gram “The Special One”.”

“Erik is super sharp and I believe that he will add real value to me, our Board and the company. I am very, very proud that he has accepted to work with me as Chairman and closest colleague in PILA PHARMA,” said Dorte X. Gram.

Photo of Dorte X Gram, photographer: Jenny Leyman