Oncology company PharmAust (ASX:PAA) will continue with the development of its Monepantel cancer treatment, including a progression towards clinical trials to demonstrate the drug’s effectiveness against COVID-19.

The announcement comes after US partner Elanco Animal Health notified the company that it’s declined an Option Agreement to further develop the use of Monepantel in the treatment of animal cancer.

The decision from Elanco was made in response to a dossier prepared by PharmAust in mid-July which summarised the rationale for further clinical trials.

That followed a round of promising clinical trial results for canine treatments in May, where the application of Monepantel successfully reduced the size of a tumour in one dog by over 60 per cent, and stabilised the disease in another four dogs.

Speaking with Stockhead, PharmAust executive chairman Roger Aston said although Elanco chose not to proceed, the company is well-positioned to explore different development options in the months ahead.

“We’ve still got a drug that’s been in development for a number of years, with extensive toxicology and safety assessments,” Aston said.

“So all the background work is there to get a quick registration of this product once we’ve got the data. They (Elanco) haven’t proceeded, but we’ve shown that in testing – both for humans and at the veterinary level in canines – the drug is active and can be used to give an exceptional result.”

“So we’ll continue pushing forward with that strategy because there is demand.”

 

Silver lining

PharmAust currently has two trials still ongoing to evaluate the right dosage levels for the use of Monepantel in the treatment of dogs with cancer.

Once completed, the company plans to move onto phase III trials to further build out the data package as it seeks other potential development partners.

In light of those developments, Aston said the decision from Elanco may reflect a de-prioritisation of early-stage partnerships in the wake of its $US7.6bn deal to buy the veterinary drugs unit from Bayer last year.

Director Robert Bishop added that the decision has “taken the shackles off a bit”, now that PharmAust is no longer legally bound to one partner.

“We’ve got two canine tests that are ongoing, plus human trials at the Royal Adelaide Hospital. So there’s a tapestry of three things that are being managed for us by independent researchers, and they’ve all found to stabilise or reduce the tumour marker in animals or humans,” Bishop said.

“So I think the essence of the (Monepantel) molecule is very powerful in multiuse areas, and the challenge for us is to find the best ones.”

“We’re free now to talk to multiple potential partners – companies such as Zoetis or Pfizer. And now we can talk with these parties at same time about both veterinary and human trials, which gives us an extra level of flexibility.”

 

COVID-19

In a dual announcement to the market today, PharmAust also said further testing of its Monepantel treatment to reduce the symptoms of COVID-19 had demonstrated more promising results.

The latest tests were carried out by the Melbourne-based specialist laboratory 360biolabs, which applied the treatment using VERO E6 cells from monkeys prior to infection.

It follows previous tests which were applied after infection, but both experiments showed Monepantel (MPL) inhibited the virus burden by up to 99 per cent.

“There’s a great urgency to develop a (COVID-19) vaccine. But also there’s enormous requirement for viable treatment options, and we think there’s an opportunity to use the drug in that manner,” Aston told Stockhead.

In its statement to the market, PharmAust said MPL may have “a distinct advantage over many other drugs in development given that it has already been used in human clinical trials and is a well-known drug with a high safety profile”.

“Ultimately, the potential benefit of MPL needs to be determined in Phase I/II trials and PharmAust is now preparing a clinical trial program in humans,” the company said.