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Pila Pharma enters agreement for toxicological studies

Pila Pharma enters agreement with CRO

Pila Pharma enters agreement for toxicological studies

30 November, 2021

The journey towards phase IIb in type 2 diabetes continues for Malmö-based Pila Pharma. On Friday, the company announced that they had signed an agreement with the CRO ERBC to conduct three-month pre-clinical toxicology studies, a prerequisite to continue the clinical development.

Biotechnology company Pila Pharma is developing XEN-D0501 for the treatment of type 2 diabetes, targeting the so-called chili receptor that has been shown to play a role in the body’s insulin secretion – making it a natural parameter in the disease.

Pila Pharma expects low toxicity

Following this fall’s listing on Nasdaq First North Growth Market, the company focus on preparing for a phase IIb study with the candidate. In connection with the listing, 35 MSEK was raised, which means that Pila Pharma is well equipped for the upcoming development steps. First up is further toxicological studies, a prerequisite to authority approval for the planned phase IIb trial.

At a first glance, it may seem strange to conduct additional preclinical safety studies at this point, given that XEN-D0501 has already undergone clinical studies. However, since Pila Pharma wants to extend the evaluation period for its candidate in the upcoming phase IIb study – to 3 months instead 1 month – they need to support the candidate’s safety profile with data from a 3-month toxicological study.

Solid safety data is an important milestone for every pharmaceutical project. In fact, the majority of failed drug development projects fail due to too high toxicity. Pila Pharma, however, estimate a limited risk for high toxicity in the case of XEN-D0501, as previous evaluations have found the candidate to be very well tolerated.

Agreement signed with CRO

To confirm XEN-D0501’s tolerability in the 3 month setting – and thus achieve another milestone in the project – the company has entered an agreement with the French Italian contract research company ERBC. ERBC provides preclinical Proof-of-Concept services for all types of drug candidates or chemical compounds, and will perform the extended toxicological study with XEN-D0501.

»I am very pleased that we have achieved yet another milestone in our development plan, and I look forward to getting these important studies executed«, Pila Pharma CEO Dorte X. Gram writes in a press release.

Production partner Almac Sciences has started the production of study material and the toxicology studies are scheduled to start next year.

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