ILA adds second Marburg study to de-risk its pivotal FDA trial

Our biotech Investment Island Pharmaceuticals (ASX: ILA) just signed a deal to run a second animal study for its Marburg virus drug, Galidesivir.

ILA is taking Galidesivir through the US FDA's "Animal Rule" approvals pathway.

Animal rule approvals allow for drugs to get FDA approvals based on animal data AND human safety data alone.

Primarily because it would be unethical to run trials on patients infected with diseases like Marburg (because of how deadly it is).

Marburg is the only Category A biothreat with no vaccine or approved treatment.

Last week ILA announced that this same drug is also being deployed under emergency use against the live Ebola outbreak in Uganda (more on that below).

Today on the marburg side of things ILA executed a Statement of Work with the Texas Biomedical Research Institute to run a second dose optimisation study in 12 primates.

It complements ILA's US Army (USAMRIID) study at a second BSL-4 lab: USAMRIID doses early (24 to 48 hours after infection), Texas Biomed once symptoms show (day 3 to 5).

Together they generate data from 32 primates against the FDA-preferred Angola strain.

The aim is to lock in the right dose and de-risk the pivotal study design ahead of a future FDA submission.

Texas Biomed is one of only four US BSL-4 primate facilities, and the only privately operated one.

Preparation for these dose optimisation studies is expected to start in October, with the infection study in early 2027.

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ILA noted in today’s announcement that Animal Rule countermeasures have averaged US$467M in US stockpile contracts, plus eligibility for a Priority Review Voucher worth ~US$200M.

We have seen three this year go close to this number:

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The Ebola outbreak worsens

Last week ILA secured approval to deploy Galidesivir under a WHO emergency-use framework into the live Ebola outbreak in Uganda.

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We covered that big update here: ILA’s drug approved for urgent use in the current ongoing major Ebola outbreak. Funded trial to generate rare human data in emergency, real world deadly virus outbreak situation.

So ILA will be able to get in human results, without needing to fund a big study.

The outbreak keeps spreading across the DRC and Uganda.

Here are recent articles we came across covering ILA's announcement and also the situation continuing to deteriorate further:

There was some wide mainstream media coverage on ILA last week following the announcement:

AFR - ILA received urgent regulatory clearance to deploy its antiviral drug Galidesivir in East Africa to combat a deadly Ebola outbreak.

Bloomberg - ILA’s shares jumped 47% after securing the emergency regulatory approvals to deploy its broad-spectrum antiviral countermeasure Galidesivir against Ebola within Uganda today.

And this one on the Ebola situation generally:

Medical Express - Virologist Nancy Sullivan warns the spreading Bundibugyo ebolavirus outbreak exposes a critical global unpreparedness for rare, highly lethal pathogens today.

And this one from just yesterday:

Bloomberg - A US humanitarian worker in the DRC has tested positive for Ebola and will be evacuated to Europe, as the CDC confirms a second American case amid an outbreak totalling 1,800 infections now.

ILA also held a webinar last week, you can watch the replay which goes into the Ebola news:

Advancing Galidesivir as a multi-filovirus countermeasure | Island Pharmaceuticals (ASX:ILA) Webinar

What's next for ILA?

🔄 In human Galidesivir Ebola trials

Just last week ILA confirmed an agreement with Ugandan authorities that will see its Galidesivir drug used in humans for the treatment of Ebola. (source)

Which we covered here: ILA’s drug approved for urgent use in the current ongoing major Ebola outbreak. Funded trial to generate rare human data in emergency, real world deadly virus outbreak situation.

ILA’s only cost to this is supplying the drug, so it is getting the trial results for free and in the very near future, which is something that rarely happens.

So positive results here could lead to more opportunities straight after.

🔄 Galidesivir Animal Rule approval pathway

Here are the two next major milestones for ILA’s Galidesivir drug:

• Stage 1 - Optimisation study - Working out the optimal dose and the best time to administer it.
• Stage 2 - Pivotal confirmatory study - The big one - this will determine how effective Galidesivir really is. Fingers crossed it improves on that 94% survival rate.

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), ILA has also signed with Texas Biomedical Research Institute for an additional study.
• 🔄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:

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