ILA granted Singapore patent for Dengue drug - exclusivity running through to 2034

Our biotech Investment Island Pharmaceuticals (ASX: ILA) just secured a new patent for one of its viral disease drugs…

ILA has two drugs:

• Galidesivir, its lead asset aimed at the deadly Marburg virus, and
• ISLA-101, a repurposed antiviral for dengue fever and other mosquito-borne diseases.

ILA is currently taking Galidesivir through the US FDA's Animal Rule pathway, where it is being developed for Marburg (more on this below), which we have followed more closely of late.

Today's news is about the other drug ISLA-101.

ILA has been granted a Singapore patent covering the use of ISLA-101 to treat dengue fever and chikungunya.

These are both mosquito-borne viral diseases with no widely available antiviral treatment.

The patent covers ILA’s drug as a standalone antiviral therapy and runs until 16 April 2034, extending ILA's exclusivity in Singapore.

At the moment ILA is in discussions for a phase 2a/b study for the dengue drug, this is outlined in the recent presentation:

(source)

While the main focus for ILA currently is on its marburg drug - Galidesivir.

Marburg is the only Category A biothreat with NO current vaccine or FDA approved treatment...

So there is a need to get a drug approved ASAP without risking deaths in trials.

ILA’s drug already has human safety trials completed and the results showed a 100% primate survival at 24-48 hour injection versus 0% for placebo):

(source)

The current Ebola outbreak also brings ILA’s Marburg drug into play

More than US$70M was spent developing Galidesivir before ILA acquired it last year, and the focus here in the near term is on treating Marburg.

It has completed human safety trials and shown strong survival data in animals infected with several viruses in the same filovirus family, which happens to include Ebola:

(source)

That matters right now because there is an Ebola outbreak spreading through Africa that continues to grow and is already the third-largest on record.

There have now been more than 1,000 confirmed cases across the Democratic Republic of Congo and Uganda.

Here are some recent headlines:

(source)(source)

What's next for ILA?

ILA held a webinar recently where the team gave a nice update on what to expect next:

(source)

🔄 Marburg disease animal rule approval pathway

Next we want to see ILA execute the following:

1. ✅ 17th November: ILA confirms Animal Rule eligibility for its Marburg drug
2. ✅ 4th February: staged approach for FDA approvals confirmed
3. 🔄 NEXT: We want to see ILA start “optimisation studies” (expected to start this quarter) ahead of a pivotal study later this year. (source)

The same announcement on 17th June also confirmed non-human primate supply for the dose optimisation study has been secured - the last operational prerequisite before the study starts.

1. 🔄 Ongoing: We want to see ILA sign more agreements with Biosecurity Level 4 (BSL4) facilities that are able to run animal studies - more sites means the studies can be completed quicker.
2. 🔲 THEN, we want to see ILA start animal trials (pivotal trial) for Marburg disease. (this is the big one).

Assuming the clinical trial results are positive, ILA will then submit to the FDA for an Investigational New Drug Application (IND) of its drug (typically a 6-month review timeframe).

And all of this happens inside the next 12 months. ILA is targeting regulatory submissions in Q1-2027:

(source)

Here are the milestones we are tracking for the trials:

Stage 1 - Optimisation study:

• ✅FDA confirmed Animal Rule eligibility
• ✅FDA confirmed staged approach for approvals
• ✅CRADA (Cooperative Research and Development Agreement) signed with USAMRIID (US Army’s premier infectious disease research institute) and Geneva Foundation (highly influential non-profit that manages nearly US$383M in military medical research funding)
• 🔄Optimisation study (commencing soon)

Stage 2 - Pivotal study:

• 🔲 Pivotal study design completed
• 🔲 Pivotal study commences
• 🔲 Pivotal study results
• 🔲 FDA submission (NDA)

IF the pivotal study results are positive, ILA could then pursue:

🔲 FDA approval of Galidesivir for Marburg

🔲 Priority Review Voucher (~US$200M based on recent sales)

🔲 US Government Strategic National Stockpile contract (potentially worth hundreds of millions in revenue)

Here is an indicative timeline on when to expect all of the above from ILA’s recent presentation:

(source)