Business model & Strategy
This section is from the Year End Report for 2023 published on August 27th 2024, and thus changes to the information can have occurred since.
PILA PHARMA’s long-term goal is to develop and ultimately bring to market XEN-D0501 as a first in class TRPV1 antagonist drug for treatment of metabolic diseases like obesity, diabetes and cardiovascular disease.
The Company’s shorter-term goal is to demonstrate the effect of XEN-D0501 on the reduction of body weight and later blood glucose in obese people with type-2 diabetes and, potentially thereafter, other diseases with an inflammatory background.
The term “Pila” means ‘to run fast’ and the idea behind the choice of this name was that the Company should work and operate in a quick and cost-effective manner, with a strong focus on the most essential goals – i.e, to focus on ‘need to do’ and avoid ‘nice to do’ as an organizational philosophy.
The Company’s main ambition and intention is to develop its primary drug candidate, a clinical stage, potent and selective TRPV1-antagonist, XEN-D0501, until a pharma partnership or sale is possible.
The Company is laser focused on consolidating the uniquely good safety profile of the candidate, in parallel to adding more evidence for a clinically meaningful effect in metabolic diseases such as diabetes, obesity and cardiovascular disease).
XEN-D0501 is currently formulated as a simple oral treatment. The small 4 mg tablet comes with very long shelf life of up to 5 years at 25ºC. The possibility of developing new formulations is something the company is evaluating. This can be useful for new indications and/or in order to diversify and differentiate the portfolio with upcoming drugs for different diseases.
Organizationally, the strategy is to hire experienced specialists to secure the best development methods for different indications. Recently, a CRO (Clinical Research Organization) has been engaged to execute the next Phase 2a clinical trial in overweight or obese persons with type 2 diabetes. A CRO act as an intermediary between the Company and the clinics and participants in the trial. The chosen CRO will conduct the study in their own clinic in London, UK.
As the Company can’t have direct ties to study participants, this partnership ensures the conduction of the trial in the fastest and most cost-efficient manner, with the larger purpose of further development of PILA PHARMA’s TRPV1 asset.
PILA PHARMA also works with a solid core of permanent consultants as well as a number of more peripheral specialist consultants and other types of contract organizations. This virtual company structure was fully adopted during 2023 and has proven itself both strong, flexible and quickly adaptable to changing priorities without losing quality. Quality is essential in drug development, but flexibility is, as we see it, a necessity in order to manage the company and its clinical projects cost-effectively through the development process.
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Pila Pharma currently has a pipeline with 3 projects, each evaluating the effect of XEN-D0501 in various indications.
* Diabetes / Obesity / Heart Failure is our primary project. A phase 2a trial is our next step to identify maximum tolerable dose and assess efficacy in body-weight and ANP.
* * Erythromelalgia / Pain (Rare Disease) is our secondary project where the intention is to conduct a phase 2a testing XEN-D0501 for its effect on pain in persons with Erythromelalgia.
* * * Abdominal Aorta Aneurism /Cardiovascular Disease is a project in early preclinical phase studying the effect of XEN-D0501 in mice on Abdominal Aorta Aneurism growth.