PharmAust Limited Monepantel Tablets Demonstrate High Safety During Phase I Trial

PharmAust Limited Monepantel Tablets Demonstrates High Safety During Phase I Trial

PharmAust Limited (ASX: PAA) provides drug manufacturing and supply services, along with operating as a drug discovery company. The company develops and supplies over-the-counter generic and patent-expired drugs and pharmaceuticals.

The company, today on 28 March 2019, has updated that it has received further positive results from its ongoing Phase I trial programme in healthy beagle dogs. This latest trial tested the safety of Monepantel tablets in an escalating single dose study. The beagles were sequentially treated with either 2, 4, 7 or 10 pills and then monitored over three days for the appearance of any adverse clinical signs.

These tablets were very well tolerated at all levels. No adverse effects, toxicity or safety-related observations were reported by the US-based independent research organisation conducting the study. This also follows the company’s earlier announcement on the 14, which indicated that one tablet was sufficient to provide blood levels that associate with anti-cancer activity.

The lack of adverse effects following administration of 10 tablets proves to have an excellent safety margin for anti-cancer treatment. Most notably, the Phase II study is due to begin on completion of the imminent 28-day pharmacokinetic (PK) programme, no apparent taste issues were noted for dogs that were administered with ten tablets in one dose. This observation attests to the high palatability and tolerance of the new tablet formulation when compared to the previously used liquid formulation.

PharmAust has now administered 61 tablets on 29 occasions to over 20 individual healthy beagle dogs, and no adverse effects have been recorded. With this very high safety margin, PharmAust will now commence daily repeat dosing tests to determine how to maintain long term Monepantel blood levels that correlate with enduring anti-cancer activity.

PharmAust’s Chief Scientific Officer, Dr. Richard Mollard, stated that these results continue to support a very high safety profile associated with Monepantel. He believes that these results further provide the company and its clinical associates with insights on a dosing strategy that will optimise the anti-cancer activity of Monepantel in the upcoming Phase II trial. He feels that in the future, it is envisaged that pet owners will be able to administer these tablets in a simple manner for their dogs at home.

On the price-performance front, the stock has posted the YTD return of -1.09%. The company also has posted returns of 10.22% & -3.56% and over the past six and three months, respectively. At the time of writing, i.e., on 28th of March 2019 AEST 1:49 PM, the stock of the company is trading at a price of A$ 0.039, up 11.429% during the day’s trade with a market capitalisation of ~A$8.84 million. The stock opened the day at A$0.037, reached an intraday high of A$0.039 and touched an intraday low of $0.037, with a daily volume of ~447,580. It had a 52-week high price of $ 0.058 and a 52 weeks low price of $ 0.030, with an average volume of more than 454,951.


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