PILA PHARMA AB (publ) (“PILA PHARMA” or “the Company”) announces that the placebo tablets to be used in coming clinical studies have now been manufactured, and GMP (Good Manufacturing Practice) certified.
Placebo tablets are a key component of most clinical trials, in order to ensure a high degree of outcome reliability. Already in June 2021 the Company received GMP certification of the 4 mg tablets containing the active pharmaceutical ingredient XEN-D0501.
As a result, both the active and the placebo tablets are now ready for use in PILA PHARMA:s upcoming phase 2b clinical study in type 2 diabetes. A clinical trial application will be sumbitted as soon as the preclinical toxicology studies are completed. Currently, drug substance production for these toxicological studies are ongoing with Almac Scienes Limited.
“We’re very pleased having received the GMP certification of the placebo tablets. This is another major step forward towards being able to initiate the clinical phase 2b studies in type 2 diabetes”, says COO Lars B. Rasmussen and CEO Dorte X. Gram.
This information is such information that PILA PHARMA AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on September 14, 2021 at 08:00 CET.
Dorte X. Gram, CEO
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