PILA PHARMA AB (publ) informed investors and others with interest in the space, that it has signed a contract with Danish preclinical Contract Research Organisation, Gubra. The aim is to demonstrate preclinical proof-of-concept of PILA PHARMA's proprietary clinical drug candidate XEN-D0501 in rats with obesity. During July, PILA PHARMA completed a rights issue of units to make "a bet on obesity" by demonstrating proof-of-concept on bodyweight regulation /obesity in first rats and then in humans.
The net proceeds of the unit rights issue, in July, provided the Company with finances to conduct preclinical trials of the Company's clinical drug candidate XEN- D0501 in obesity. The associated warrants of series TO2 will have it's subscription period between 5 and 15 February 2026 after the read-out of the rat studies. The net proceeds from the warrants are intended to finance clinical trials of the Company's clinical Drug candidate XEN-D051 in obesity.
The new collaboration with Gubra will facilitate the first step to demonstrate proof-of-concept in obese rats. The discussions on choice of obesity model and study design were initiated already in July when a "slot" in Gubra's research facility was also reserved. With all details now settled, the contract is signed.
It has been chosen to study the effect of 4 weeks of treatment with PILA PHARMA's TRPV1-inhibitor drug candidate XEN-D0701 in both obese male DIO and Zucker rats. The DIO rat is a standard obesity model where normal rats are fed a high fat diet to induce obesity. The Zucker rat is another relevant obesity model where rats due to a mutation spontaneously overeat and develop obesity on a normal diet, simply due to the excess amount of calories consumed.
Generating proof-of-concept in obesity would put PILA PHARMA in a unique position as a pioneering innovator in the space and enable further clinical studies in humans living with obesity with the goal of establishing a comprehensive and meaningful data package. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable.
PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing. Abdominal aorta aneurysm is a cardiovascular disease with 'ballooning' of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma.
It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available.
In December 2024, in collaboration with Uppsala University, PILA PHARMA'sTRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysM growth in mice, establishing preclinical proof-of- concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.
