PharmAust kick-starts MND trial with lead drug and reports positive signs in canine cancer trials
The addressable market for MND/ALS is US$3.6 billion.
Clinical stage biotechnology company PharmAust’s (ASX: PAA) September quarter was highlighted by the commencement of its Motor Neurone Disease (MND) trial, recruiting its first four patients, as additional patients undergo screening to become the next-in-line.
As MND affects more than 350,000 of the global population and kills more than 100,0000 people every year, the largest independent funder of MND research in Australia, FightMND continues to support PharmAust in its efforts to mitigate the impact of the disease.
The Perth-based company, developing therapeutics for both humans and animals, also made significant progress in its efforts to push the company’s lead drug monepantel (MPL) in canine cancer trials.
PharmAust’s progress has led to more MPL being manufactured as future human and canine clinical trials look set to happen in the near future.
The company’s 100% owned subsidiary Epichem’s September quarter was highlighted by the appointment of new business development manager, to go along with its new general manager assuming her position.
As for the financial side, PharmAust’s cash position at 30 September 2022 was $1.9 million, with total available funding for future operating activities of $2.2 million – placing the company in an adequate position to continue its current activities.
MND trial
During the September quarter, PharmAust kick-started its MND trial, with the first four patients recruited and dosed with MPL, in an attempt to mitigate the effects of the disease.
The company’s efforts were boosted by $173,034 from FightMND, as part of its $881,085 commitment, to assist with study costs.
PharmAust’s MND trial aims to evaluate the safety and tolerability of MPL in patients living with MND, while also identifying if the drug can slow the progression of the disease.
The company was also granted ethics approval to make minor amendments to the Clinical Study Protocol to refine the study design and accelerate recruitment.
Pre-clinical study into the effects of MPL on MND found that it can aid in slowing disease progression through cleaning harmful materials in a motor neurone that stick together hindering functionality.
PharmAust aims to have MPL receive orphan drug designation by the FDA for the indication of MND.
Phase II canine cancer trials
During the September quarter, the company made significant progress with its lead drug in canine cancer trials.
PharmAust hopes to develop and partner a product that replaces the current use of prednisolone alone, and prevent the need for chemotherapy in the treatment of dogs.
MPL has been found to offer canine cancer patients a much better safety profile with reduced adverse effects typically endured as a result of undergoing chemotherapy.
During the company’s phase 2a and 2b studies in canines, MPL was found to provide effective anti-cancer activity, which has led to Phase 3 registration trials.
PharmAust also announced during the quarter it recruited the first pet dog with B cell lymphoma in its US canine trial.
Veterinary trial centres have been set up in Australia, New Zealand and the United States to understand the anti-cancer benefit of MPL in dogs newly diagnosed with B-cell lymphoma and are yet to receive any cancer treatment.
The company said as a result of positive outcomes from MPL monotherapy, PharmAust is preparing for a successful phase 2 completion and the commencement of a subsequent phase 3 registration trial.
Discussions have commenced for FDA registration and GCP implementation, as the company also leads talks with potential licencing partners for canine cancer.
Phase II human cancer trial and COVID-19 testing
As MPL shows positive signs in its efforts aiding canines with cancer, PharmAust moves towards progressing the evaluation of MPL in human trials.
Clinical interest has focused on leukaemia, glioblastoma, oesophageal, gastrointestinal, ovarian and pancreatic cancers.
PharmAust found a Principal Investigator in the United States to evaluate the new MPL tablet in human phase 2 cancer trials, following on from the phase I clinical trial undertaken back in 2015.
The company announced during the quarter it’s called on Ergomed Clinical Research (LSE: ERGO), to be the contract research organisation (CRO) for the company’s COVID-19 clinical trials.
The company hopes the MND study will provide adequate phase 1 pharmacokinetic (PK) data for both the MND and COVID-19 trials, meaning it can jump to a phase 2 trial in COVID-19, rather than a phase 1 study – saving it both time and money in the long term.
Epichem
PharmAust’s 100% wholly-owned subsidiary Epichem’s start of the financial year commenced with new general manager Fiona Milner assuming her position and Anusha Aubert being appointed as the new business development manager.
The company’s discovery and analytical services have been performing strongly for some time now, as all of the service departments in Epichem have been highly focused on revenue raising projects and contracts.
Epichem’s Q1 FY2023 saw the engagement of Chevron for a significant project, which is ongoing and has already received “excellent customer feedback on both progress and results”.
The company’s work with OHD (Oxidative Hydrothermal Dissolution) technology continues to build momentum and garner high engagement as it welcomes a range of clients across different industries.