Which ASX companies are resurrecting abandoned drugs? Part 2

Despite effectiveness in late-stage trials, up to 25% of potential treatments fail to reach market
Several ASX companies are repurposing or resurrecting abandoned drugs including LTR Pharma
Island Pharmaceuticals focuses on repurposing drugs as a strategy to move quickly into clinical trials

Despite demonstrating effectiveness in late-stage trials, up to 25% of potential pharmaceutical treatments never reach the market, according to CEO of Race Oncology (ASX:RAC) and seasoned biotech executive Daniel Tillett.

He says there are various reasons for the abandonment of drug development. He says during the lengthy drug development process, companies may alter their commercial focus, while M&A activity within the pharmaceutical industry can also contribute to the abandonment of effective treatments.

Additionally, complex administration requirements render some drugs commercially uncompetitive, even if they offer superior efficacy.

However, there are strategies for resurrecting abandoned drugs, including out-licensing, reformulation or repurposing for rare diseases.

The approaches aim to revitalise promising drugs while navigating challenges in drug development and commercialisation. There are several ASX-listed companies resurrecting or repurposing abandoned or under utilised drugs.

In Part 2, we will delve into some of these ASX-listed companies.

READ Which ASX companies are resurrecting abandoned drugs to bring effective treatments to patients? Paret 1

LTR Pharma (ASX:LTP)

Listing on the ASX in December 2023, the clinical stage biotech is pioneering a novel intranasal (spray) technology called SPONTAN, which is designed to be a fast-acting treatment for erectile dysfunction (ED).

While men have been able to swallow a pill to deal with ED since a class of drugs called PDE5 inhibitors hit the market in 1998, including well-known Viagra, most of them take about an hour at least to work or for users to be able to function at their full sexual capacity.

But SPONTAN is looking to bring back youthful spontaneity of sex, providing on-demand delivery and faster effect than the pills of old by repurposing PDE5 inhibitors to by-pass the digestive track and starting working in 10-15 minutes.

LTP chair Lee Rodne says there’s numerous advantages of repurposing drugs, including that most have previously shown they’re safe in humans already.

“This can reduce the number of clinical trials necessary for a repurposed drug,” he says.

“But most of these drugs still need to show that they work in the new intended indication or treatment and require efficacy studies.”

He says in LTP’s case, the company has the advantage of its drug not only having shown safety in humans but importantly that it works for the intended indication and has already been approved as an oral therapy for the treatment of ED.

“Our repurposed strategy is unique as we’re just changing the delivery of an already approved drug for the treatment of ED and since our drug is already approved and on market as an oral therapy, we’re not required to show that the drug works as it’s already been proven,” he says.

“We are the world’s first nasal spray product that is using a gold standard and proven drug for the treatment of ED and our nasal spray delivery is specifically designed as a faster and more effective treatment than the oral tablets.

“From a commercial perspective, our repurposing strategy of changing the administration of an approved drug for the same indication, will support a much quicker and cost effective approval process than other repurposed drugs.”

LTP recently announced it had started patient dosing phase in its pivotal clinical study being conducted in Sydney, which aims to assess the relative bioavailability of SPONTAN.

Island Pharmaceuticals (ASX:ILA)

ILA CEO Dr David Foster told Stockhead the antiviral drug development company focuses on repurposing drugs as a strategy to move quickly into clinical trials.

“One of the main benefits of having a repurposing strategy is that years of development and potentially hundreds of millions in expense have already been supported by a third party,” he says.

“In many cases we can rely on the data they generated to support development of our program.”

Foster says it is most common for repurposing companies to take an approved drug, reformulate it and pursue an approval in the same or similar indication as the original drug.

However, he says ILA is taking a slightly different approach with its lead drug candidate, ISLA-101, which was initially developed as a cancer drug but has never been approved.

“Based on some excellent work by investigators at Monash University in Melbourne, we discovered that ISLA-101 also has excellent activity against a variety of viruses, including all four strains of dengue fever as well as the West Nile and Zika viruses,” he says.

“In our situation, a drug that was initially developed as a cancer drug, is now being investigated against the dengue virus and has the possibility of being pursued against a range of other mosquito-borne viruses.

“We have been able to license a patent portfolio that supports this new use of a compound developed many years ago and expect to have additional opportunities to ‘evergreen’ the patent portfolio.”

Foster says with the rapid spread of dengue fever across the globe and major outbreaks becoming more and more common, the need for a preventative and treatment has never been greater.

The World Health Organisation (WHO) reports about half of the world’s population is now at risk of dengue with an estimated 100–400 million infections occurring annually.

“With the recent completion of our ISLA-101 Single Ascending Dose study we are moving closer to our Phase 2a clinical trial, which we hope to commence in early 2H 2024,” he says.