Canadian CRO selected to reformulate cancer inhibitor

Pharmaceutical research company PharmAust (ASX:PAA) has appointed Canadian-based contract research organisation (CRO) BRI Pharmaceutical Research Inc to reformulate its lead drug candidate, Monepantel (MPL), for clinical trials.

MPL is a novel, potent and safe inhibitor of the mTOR pathway — a key driver of cancer. The drug has already been evaluated in Phase I clinical trials in humans and dogs, with PharmAust recently receiving preliminary analysis from its Phase II dog lymphoma trial. MPL treatment was found to be well tolerated and produced a significant reduction in key prognostic biomarkers, with the Phase II trial showing that three out of four dogs achieved stable disease and reduction in tumour size after just two weeks of daily treatment.

Now, BRI will seek to evaluate a range of well-validated platforms to determine the optimal formulation for oral delivery of MPL. This work will build on initial efforts from Juniper Pharmaceuticals, who successfully reformulated liquid MPL in the form of Zolvix into capsules. These are being used in the Phase II dog trial, though it has become apparent the current capsule formulation is not suitable for more advanced clinical trials due to the unpalatability of Zolvix even when encapsulated.

To address this, BRI has been selected to prepare a fully optimised MPL formulation that meets the exacting requirements for scaled manufacture, late-stage clinical trials and ultimately, registration. The primary objective is to mask the unpleasant taste of MPL to address the compliance issues encountered with previous formulations. Further aims include increasing the dose of MPL contained in each tablet or capsule to reduce overall pill burden, maximising the amount of drug delivered into the bloodstream and ensuring the drug is stable when stored.

“We’re really excited to be working with BRI, who have an impressive track record in successfully reformulating drugs for clinical development,” said PharmAust CEO Dr Richard Hopkin. “Within six months we expect to have a reformulated product amenable to scaled manufacture and fully optimised for clinical trials in dogs and humans. Clearly, successful delivery of a reformulation product will open up significant commercial opportunities for the company.”

PharmAust (ASX:PAA) shares were trading 4.62% higher at $0.068 as of around 12 noon on Tuesday.