The expansion of the canine trial of Monepantel to the US comes after successful earlier trials in both Australia and New Zealand.
Clinical stage biotech PharmAust (ASX:PAA) will expand its Monepantel (MPL) B-cell lymphoma canine trial to the US, after signing an agreement with two US-based vets.
Pathway Vet Alliance and Heart of Texas (HoT) Veterinary Specialty Centre have both agreed to join PharmAust’s pet dog B-cell lymphoma trial under the FDA pilot program using MPL tablets.
Under the agreement, PharmAust will send sufficient tablets for HoT to treat up to 10 dogs, which follows the FDA pilot program guidelines.
The US expansion builds on PharmAust’s successful new trial site in New Zealand, where it recently completed its first 28-day treatment of a dog with B-cell lymphoma.
Trial recruitment is also continuing in Australia, where PharmAust has already treated 25 pet dogs using MPL monotherapy.
With continued positive outcomes, the company is now preparing for a successful Phase 2 completion, as well as the start of a subsequent registration trial.
“One aim of expanding the study sites is to accelerate the enrolment of case numbers required to enable PharmAust to close out the Phase 2 study as quickly as possible,” said trial principal investigator, Kim Agnew.
Combination therapy demonstrates benefits
In addition to the trial MPL monotherapy, eight dogs have now been treated post-trial using ongoing MPL in combination with standard of care, prednisolone.
The MPL and prednisolone combination has to date provided median and average survival times of approximately 140 days (or 20 weeks).
This compares favourably with the eight- to nine-week median, and surpasses average survival times expected for dogs with B-cell lymphoma when treated with prednisolone alone.
Furthermore, owners have reported increased quality of life of their pets after using the combination treatment.
“The combination of MPL and prednisolone post-trial to date is doubling average and median survival times compared to prednisolone alone, enabling a greater number of trial arm options to be prepared for a registration trial,” said PharmAust chief scientific officer, Dr Richard Mollard.
Dr Mollard said quality of life may be the most important outcome for pet dogs, as we don’t know how pet dogs balance expectations of their quality of life with expectations of quantity of life.
Looking ahead, PharmAust says that it remains on track for successful Phase 2 trial endpoints, as it sets eyes on a potential Phase 3 trial.
This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.