Juniper Pharma Services to reformulate Pharmaust candidate for Phase II trials

Pharmaust deal: Dr Nikin Patel, president at Juniper Pharma Services

The CDMO will also manufacture 20,000 capsules of the reformulated monepantel solution for the Australian company

The contract development and manufacturing organisation (CDMO) will also manufacture 20,000 capsules of the reformulated MPL solution for the Australian company under GMP, ensuring that the Phase II clinical data are admissible to regulators as part of any subsequent submissions.

The primary need to reformulate MPL stems from the particularly unpleasant taste of the current MPL formulation, as used at the Royal Adelaide Hospital during the Phase I study. Despite showing significant activity of MPL on tumour markers such as p70S6K and p-4E-BP1, compliance by patients in taking the drug for 28 days 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.

“We have shown that oral MPL is effectively absorbed in humans and canines yielding blood levels of the drug which have shown both safety and activity against key tumour markers.”

With an established track record of helping pharmaceutical companies develop and produce oral and topical drug products for clinical trials, Juniper Pharma Services is able to optimise formulation performance through its science-led approach to projects.

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.

“As our reputation in the market for supporting drug developers with both simple and complex formulation challenges continues to grow, we are seeing more companies approach us at an earlier stage to transform their promising concepts into finished dosage forms to deliver the best possible chance of clinical success.”