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There has been some discussion that even outside the HIV/COVID...

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    There has been some discussion that even outside the HIV/COVID field that BIT225 could be the next generation anti-viral drug - and I know that BIT has done some research into Dengue fever.

    This is a really interesting article on repurposing of drugs. Could be very pertinent for BIT in expanding the horizons for BIT225.

    Which ASX companies are resurrecting abandoneddrugs? 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

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

    He saysthere are various reasons for the abandonment of drug development. He saysduring the lengthy drug development process, companies may alter theircommercial focus, while M&A activity within the pharmaceutical industry canalso contribute to the abandonment of effective treatments.

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

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

    Theapproaches aim to revitalise promising drugs while navigating challenges indrug development and commercialisation. There are several ASX-listed companiesresurrecting 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 bringeffective treatments to patients? Paret 1

    LTR Pharma(ASX:LTP)

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

    While menhave been able to swallow a pill to deal with ED since a class of drugs calledPDE5 inhibitors hit the market in 1998, including well-known Viagra, most ofthem take about an hour at least to work or for users to be able to function attheir full sexual capacity.

    ButSPONTAN is looking to bring back youthful spontaneity of sex, providingon-demand delivery and faster effect than the pills of old by repurposing PDE5inhibitors to by-pass the digestive track and starting working in 10-15minutes.

    LTP chairLee Rodne says there’s numerous advantages of repurposing drugs, including thatmost have previously shown they’re safe in humans already.

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

    “But mostof these drugs still need to show that they work in the new intended indicationor treatment and require efficacy studies.”

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

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

    “We arethe world’s first nasal spray product that is using a gold standard and provendrug for the treatment of ED and our nasal spray delivery is specificallydesigned as a faster and more effective treatment than the oral tablets.

    “From acommercial perspective, our repurposing strategy of changing the administrationof an approved drug for the same indication, will support a much quicker andcost 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.

    IslandPharmaceuticals (ASX:ILA)

    ILA CEO DrDavid Foster told * the antiviral drug developmentcompany focuses on repurposing drugs as a strategy to move quickly intoclinical trials.

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

    “In manycases we can rely on the data they generated to support development of ourprogram.”

    Fostersays 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 theoriginal drug.

    However,he says ILA is taking a slightly different approach with its lead drugcandidate, ISLA-101, which was initially developed as a cancer drug but hasnever been approved.

    “Based onsome excellent work by investigators at Monash University in Melbourne, wediscovered that ISLA-101 also has excellent activity against a variety ofviruses, including all four strains of dengue fever as well as the West Nileand Zika viruses,” he says.

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

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

    Fostersays with the rapid spread of dengue fever across the globe and major outbreaksbecoming more and more common, the need for a preventative and treatment hasnever 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 therecent completion of our ISLA-101 Single Ascending Dose study we are movingcloser to our Phase 2a clinical trial, which we hope to commence in early 2H2024,” he says.


    Which ASX companies are resurrecting abandoned drugs? Part 2 - *
 
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