A potential new oral solution for obesity & diabetes [PILA PHARMA x Breakfast Business w. Joe Lynam]

PILA PHARMA's CEO, Gustav H. Gram participates in Irish #Business, & #Investment radio show Business Breakfast with Joe Lynam to discuss #Obesity, #Diabetes & the market for oral solutions.

In the brief morning chat, CEO Gustav H. Gram elaborates on the outlook and possibilities for PILA PHARMA with regards to the possibilities of addressing the larger global market for these metabolic conditions with a scalable tablet solution. Equally, Joe & Gustav touched upon the potential implication and uncertainty for biotech and pharmaceutical companies with regards to the tariff situation.

The feature aired live in English on April 9, 2025 at 7:30 CEST.
Link to article: https://www.newstalk.com/breakfast-business/new-oral-weight-loss-drug-could-put-pressure-on-companies-to-slash-prices-2153129

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PILA PHARMA is a clinical stage, TRPV1-receptor specialised company developing novel treatments inflammatory diseases such as Obesity, Type-2 diabetes, cardiovascular disease and pain.

PILA PHARMA aim to develop XEN-D0501, a potent, selective, TRPV1 antagonist, as a potential novel first-in-class treatment inflammatory disorders, but primarily diabetes and other #cardiometabolic related disorders.

Furthermore the company is evaluating the molecule for treatment of pain in the rare disease Erythromelalgia for which the company was awarded Orphan Drug Designation by the US FDA in 2021.

Other potential diseases with an inflammatory background are being evaluated as additional indications. The company most recently also achieved proof-of-concept in a preclinical study in cardiovascular disease.

The molecule, XEN-D0501, appears to be safe in healthy volunteers as well as in patients (previously been in trials for overactive bladder disease, chronic cough and type 2 diabetes) and has been shown to significantly improve insulin secretion in people with type-2 diabetes following 1 month oral treatment with XEN-D0501, 4 mg BID.

In order to determine effects over more than 1 month, a 13 week toxicology programme has recently been conducted in rodents and non-rodents, without clinical adverse events.

Furthermore, good data has been shown on ANP, a cardiovascular biomarker for heart failure. A highly statistically significant reduction which indicates a strong cardio protective benefit of XEN-D0501.

For cardiovascular disease, the company also has a pre-clinical project ongoing with University of Uppsala for the treatment of Abdominal Aorta Aneurism which is a cardiovascular condition that annually kills 1% of men above the age of 65.

The hypothesis is that the lead candidate, XEN-D0501, would slow progression of the disease to lethal stage. The company announced in December 2024 that it had achieved proof-of-concept results with significant decreases in both aorta dilatation and % of subjects that progressed to lethal stage.

The current plan for the diabetes/obesity project is to move on with a dose-finding study in overweight type-2 diabetic patients to determine the best dose level for a phase 2b. It's aimed to also observe various key efficacy endpoints including weight loss, energy burn, and cardiovascular markers.

This will be followed by a larger phase 2b trial in approx. 300 patients.

For the rare-disease project, first step is to conduct a proof of concept study in fewer patients, for which a study plan has been developed.

The company aspires to be a clinical late-stage company making strides into the ever-increasing cardiometabolic and specifically obesity/diabetes space with real potential to improve the #healthspan for a large proportion of the global population. The company wishes to progress its pipeline tracks to proof-of-concept after which it is desired to form partnerships.

The scientific hypothesis regards treating the inflammatory state which occurs in many diseases. Thus, PILA PHARMA's lead molecule, XEN-D501, which is a TRPV1-antagonist, would potentially be able to play a key role with its anti-inflammatory properties.