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Juniper Pharma To Reformulate Phase II PharmAust Drug

February 1, 2016

Will reformulate monepantel due to unpleasant taste

Juniper Pharma Services has been selected by PharmAust Ltd. to reformulate monepantel (MPL) for its Phase II studies. PharmAust will also manufacture 20,000 capsules of the reformulated MPL solution for Juniper under GMP, ensuring that the Phase II data are admissible to regulators as part of any subsequent submissions.
 
MPL needs to be reformulated because of the unpleasant taste. While the Phase I study showed significant activity of MPL on tumor markers such as p70S6K and p-4E-BP1, compliance was poor due to nausea associated with its exceptionally poor palatability.
 
Dr. Roger Aston, chairman at PharmAust, said, “We expect the reformulation process to take about 12 to 14 weeks, which gives us time to prepare clinical trial submissions to regulatory bodies based on the capsule format. 
 
Dr. Nikin Patel, president at Juniper Pharma Services, said, “We are very pleased to have secured this project with PharmAust as it further demonstrates our specific expertise in assisting companies from across the globe in reformulating and manufacturing products such as capsules for clinical trials.”

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