• Determination of a clinically safe and efficacious dosing regimen of monepantel (MPL) for the treatment of dogs with B-Cell Lymphoma
  • Treatment with MPL was safe, well-tolerated and there were no treatment-related deaths or severe adverse reactions to MPL
  • Overall clinical benefit compares favourably to the most recent FDA product approved for B-Cell lymphoma
  • Pivotal studies to proceed in 2024 to support product registration

 

There’s potential for major value to come out of top-line data from a Phase 2 veterinary clinical study on PharmAust’s monepantel treatment of Canine B-Cell lymphoma as pushes its life-saving drug into the US market.

Studies are showing no severe adverse reactions, no treatment-related deaths and point towards safe efficacy for PharmAust’s (ASX:PAA) ground-breaking treatment of canine lymphoma.

It’s estimated that ~6 million dogs are diagnosed with cancer in each year in the US. Lymphoma is the most common haematological neoplasm of dogs, with B-Cell lymphoma being the most common histologic subtype.

B-Cell lymphoma has a poor prognosis, and without treatment, death can occur within weeks of diagnosis.

A vet product market of >$22bn in the US is driven by an increasing willingness for owners to spend more on their pets as they are considered part of the family – something PharmAust is keenly looking to access with its treatments.

PharmAust has been progressing similar MPL treatments for us humans with Motor Neurone Disease/Amyotrophic Lateral Sclerosis (MND/ALS) and is currently progressing clinical trials.

 

Design points

The MPL study was a Phase 2, open-label, single-arm, dose-finding study conducted at nine sites in Australia, New Zealand, and the US.

Its objective was to determine a clinically safe and efficacious dose of MPL for the treatment of dogs with B-cell lymphoma whilst maintaining quality of life.

The dogs received a once-daily treatment of MPL at home for 28 days.

Five separate cohorts of dogs received different dosing regimens of MPL across a 28-day period before a loading dose of 100 mg/kg body weight (BW), followed by a maintenance dose of 25 mg/kg – which was selected as the optimal dose based on efficacy and safety data.

 

Study results

54 dogs of mixed breeds of an average age of 8yrs old (range 3-13 years) and a median weight of 29.6 kg (range 6.5-87) participated in the study.

50% were neutered males and 40.4% spayed females, with late-stage disease at diagnosis (61.5% Stage IV; 28.8% Stage V) with prescapular (92.3%), popliteal (90.4%), and submandibular (78.8%) lymphomas.

In terms of safety, there were no treatment-related deaths and most of the adverse effects (haematological and serum chemistry) reported were mild to moderate in severity that were self-limiting and responded to supportive care.

 

Partnering Update

Confidential commercial discussions are ongoing with a number of potential veterinary partners. The planned pivotal field studies to support product registration have been designed to incorporate feedback from potential partners and continue to proceed in parallel with business development efforts.

PharmAust CEO Dr Michael Thurn says the potential for PharmAust to achieve a major value inflexion point by advancing MPL through to product registration with the CVM makes good business sense.

“The minor investment to conduct the pivotal registration studies could release significant shareholder value through receiving conditional approval for MPL from the CVM.

“LAVERDIATM, the most recently approved treatment for B-Cell and T-Cell Lymphoma, was acquired by Dechra Pharmaceuticals PLC (LSE:DPH) for US$64.5m in 2022.

“As our MPL tablet has a comparable efficacy profile to LAVERDIATM and offers significant advantages in quality of life and safety for both the dog and the owner, we are confident in the commercialisation of MPL for canine cancer.”Video Presentation

A video presentation providing further information about the Phase 2 veterinary clinical study and future directions.

 

 

 

 

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.

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