ILA begins GMP drug manufacturing, the first batch for Uganda Ebola response

Our 2025 Biotech Pick of The Year Island Pharmaceuticals (ASX: ILA) just started GMP manufacturing of its antiviral drug Galidesivir.

This drug is being manufactured for two different programs:

• To support the current outbreak of Ebola in the DRC (specifically neighbouring Uganda where today’s announced batch is planned)
• To support ILA’s Marburg trials under the FDA Animal Rule (where the second batch from November will be used, more on this below)

Manufacturing commenced yesterday (1st October) at ILA's contract manufacturer PI Health Sciences.

The first 5kg batch of manufacturing is targeted for completion by the end of October.

This batch is already earmarked for ILA's approved emergency-use program in Uganda, treating patients in the current Bundibugyo Ebola outbreak under the WHO's MEURI framework.

(MEURI is “Monitored Emergency Use of Unregistered and Investigational Interventions” - this is a protocol that allows unproven drugs to be used in an emergency, because there is no other available option.)

The Bundibugyo Ebola outbreak has now reached 8,137 confirmed cases and 3,926 confirmed deaths (a ~48% fatality rate), and there is still no approved treatment for this specific strain. (source)

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Treatment would happen under a prospective protocol, so ILA will be able to collect clinical, safety and virological data from any patients treated.

So should the drug be administered, ILA will be getting real world, in human trial data, to complement the existing data it has on the drug.

This could result in ILA getting data on a trial without needing to organise and set up a study, which isn’t exactly reasonable for this - because infecting people with Ebola to test a treatment isn’t humane.

The current Ebola outbreak continues, this is from our recent article which illustrates clearly the trajectory the current outbreak is on compared the the prior biggest:

(source)

We covered ILA's latest progress on Ebola in that article here: ILA ramping up drug manufacturing to help fight “worst ever” Ebola outbreak.

More on ILA’s Marburg program

Marburg virus disease is a rare, severe, and often fatal illness that damages blood vessels and causes dangerous bleeding inside and outside the body. It belongs to the same virus family as Ebola.

The Marburg virus is classified as a high-priority potential bioterrorism agent due to its extreme lethality and severe symptoms.

A second 5kg batch of ILA’s Galidesiver drug is due to be completed by late November, supporting ILA's broader Ebola strategy and in particular its planned pivotal Marburg study.

Marburg remains Galidesivir's primary FDA approval pathway, via the FDA's Animal Rule, which allows approval on animal data plus human safety data alone.

🎓Read more on the FDA’s Animal Rule process in detail here: The journey for ILA to get a drug to market in under 12 months

Marburg is a Category A bioterrorism threat with up to 88% fatality, and the only Category A biothreat with no vaccine or approved treatment.

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)

Two dose optimisation studies are on the agenda for ILA, with the US Army (USAMRIID) study expected to start this quarter, then the Texas Biomed to follow in Q1 2027.

(Optimisation studies are done to help refine the treatment dosage amount and timings)

Following the optimisation studies comes the “pivotal study, which should determine how effective ILA’s treatment is.

IF ILA’s treatment is proven successful, ILA would be eligible for a Priority Review Voucher (recent sales ~US$200M), and Animal Rule countermeasures have averaged US$467M in US stockpile contracts.

Read more about Marburg and the PRV value here: ILA’s drug is also being advanced for Marburg disease.

What's next for ILA?

🔄 Ebola (Uganda deployment):

1. ✅ Government + regulatory approvals for compassionate use in Uganda
2. 🔄 Drug supply / manufacturing scale-up (additional supply commissioned) (source)
3. 🔲 Drug shipped to Uganda for use (today confirmed the first batch has begun manufacturing) (source)
4. 🔲 First patients dosed (due within CY2026) - (source)
5. 🔲 First human efficacy, safety and virological data from the field
6. 🔲 Any expansion of deployment beyond Uganda (DRC?)

🔄 Animal rule approvals process for Marburg disease

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

• Stage 1 - Optimisation studies (USAMRIID in Q4 26 & Texas Biomedical Research Institute in Q1 27) - The aim will be to determine 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)
• 🔄Optimisation study (commencing soon)

Stage 2 - Pivotal study:

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

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

(source)