PharmAust Produces The First Batch Of 2,000 Monepantel Tablets For The Phase I Clinical Trials

PharmAust Produces The First Batch Of 2,000 Monepantel Tablets For The Phase I Clinical Trials

PharmAust Limited (ASX: PAA), domiciled in Australia, is a clinical-stage pharma company developing cancer drugs for both humans and animals. It lowers the costs and risks of development by repurposing the marketed drugs which are supported by Epichem. Epichem is a 100% owned subsidiary of PAA, situated in Western Australia, which is engaged in generating significant annual revenues by delivering products and services in medicinal and synthetic chemistry to the healthcare industry in 35 countries worldwide. Monepantel (MPL) is a newly formulated drug developed by PAA for the treatment of parasite infections in food chain animals.

Today, PAA has announced that it has entered into an agreement with a US Contract Research Organisation for the Phase I clinical trials with MPL tablet in healthy beagle dogs. The Phase 1 trial will start from 19 February 2019.

PAA has also announced that it has finalised the MPL tablet research, development and scaled manufacturing. It has produced the first batch of 2,000 tablets in collaboration with Catalent, San Diego Inc. for the Phase 1 trial.

Catalent is a US-based health care company engaged in providing solutions for biologics, drugs, and consumer health products. In FY18, it generated a revenue of approx. US$2.5 billion.

Under the Phase I trial, there are four stages. The first stage starts with validating the optimal dietary conditions for MPL administration, i.e., whether to take the drug in an empty or full stomach. The second stage is to determine the safety of MPL at single dose in a dose escalation study. The third stage starts with analysing the frequency of dosing required, i.e., every second day or third day, to achieve blood levels predicted to be compatible with anticancer activity. And finally, conduct a 28-day repeat-dose drug level study based on the other three stages to identify optimal tablet administration frequency as a prelude to start the Phase II anticancer studies in pet owners’ dogs with cancer.

Dr Richard Mollard, Chief Scientific Officer of PAA, commented that PAA can now start with a standardised and regulatory compliant tablet for the Phase 1 trial to determine the dosage range compatible with anticancer blood level activity.

Moreover, he said that this trial would provide the information which is required for the upcoming Phase II trials to enable the best possible treatment for pet owners’ dogs with cancer. The safety component of this trial design would potentially form part of the bridging component required for regulatory authorities such as the FDA for establishing an Investigative New Drug Application for clinical trials in humans.

Looking at PharmAust Limited’s stock performance, it has generated a positive return of 22.22% during the past six months. It is currently trading at A$0.046 (as on 07 February 2019, 02:51 pm AEST) with a surge of 4.55 % in the price during the day’s performance following the release of the updates. PAA has approx. 198.98 million shares outstanding with a market cap of circa A$8.76 million and 52-week high and low of A$0.069 and A$0.033 respectively.


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