ASX listed biotech PharmAust has signed an agreement with US pharmaceutical heavyweight Elanco that could potentially expedite the early proof of principle phase two anti-cancer trials of its flagship anti-cancer drug Monepantel in dogs.
Under the data and regulatory rights agreement, Elanco will allow the company to reference certain safety and blood chemistry data that were generated for the regulatory approval of Monepantel in Australia, New Zealand and the EU, as an anti-parasitic drug in livestock animals.
PharmAust said this data is expected to have a very high level of precision and detail as data and documentation for drugs given to livestock animals are required to be extremely comprehensive.
The agreement supports the option agreement executed between PharmAust and Elanco in April 2018.
Under the previous deal, Elanco will supply the Perth-based company with high-grade Monepantel for use in clinical trials in dogs to determine the cancer-fighting capacity of the drug.
In return, PharmAust granted Elanco an option to negotiate for an exclusive worldwide royalty that would allow it to use PharmAust’s IP in the field of animal cancer treatment.
PharmAust Chief Scientific Officer Dr Richard Mollard said: “Having access to this documentation and data package enables PharmAust to approach regulatory authorities in the US and Europe to potentially expedite the early proof of principle Phase II clinical trials in pet owner’s dogs with cancer.”
Monepantel has proven activity as an anti-parasite drug in livestock animals and has a very good safety record following years of use.
PharmAust recently received new data from Canada’s BRI Biopharmaceutical Research that indicates that a specific combination of diet and excipient, which are agents included in tablets that help shape or dissolve the tablet but are not the active ingredient itself, up to twice the amount of Monepantel can be delivered into the bloodstream of dogs.
Last year, the company said that just one of its improved tablets can provide blood levels of Monepantel that exceed those previously predicted to achieve anti-cancer activity required in the previous pilot study in dogs with B-cell lymphoma.
The company remains on track to commence clinical trials in dogs using these tablets early this calendar year.
