ILA - completes screening for USAMIRD Marburg disease study

Our 2025 Biotech Pick of The Year Island Pharmaceuticals (ASX: ILA) just completed screening of 22 NHP’s at for United States Army Medical Research Institute of Infectious Diseases (USAMIRD) marburg study.

ILA is developing Galidesivir as a treatment for Marburg virus.

Marburg is a Category A bioterrorism threat (the highest level) with a fatality rate of up to 88%, and it is the only Category A biothreat with no vaccine and no approved treatment.

More than US$70M was spent developing Galidesivir before ILA acquired it last year.

Now ILA about to run two different dose optimisation studies:

1. With the United States Army Medical Research Institute of Infectious Diseases (USAMRIID): dosing early, 24 to 48 hours after infection. Expected to start this quarter (Q4 2026). 
2. With the Texas Biomedical Research Institute: dosing later, once symptoms show (day 3 to day 5), in 12 primates. Expected to follow in Q1 2027.

Both to determine most effective/safest dose size, before a bigger program commences testing for efficacy (the pivotal study).

ILA now running a two phase process:

• The first stage is an optimisation study - to work out the optimal dose and when to administer that dose
• The second pivotal confirmatory study will follow right after - The pivotal study will be when we see how effective ILA’s Marburg drug really is. Fingers crossed it improves on the previous studies, which had survival rates averaging 94%.

All part of ILA’s push to get Animal Rule Approvals for its drug against Marburg.

Animal Rule approvals are typically only available for treatments on diseases that are too deadly to run Phase 1/2/3 clinical trials in humans on.

(skipping the typical 10-15 year Phase 2 and 3 trial process for drugs trying to get to market).

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” ahead of a pivotal study later this year.
4. 🔄 ILA has two sites doing dose optimisation studies - (USAMRIID and Texas Biomed), USAMRIID dosing is to start this quarter, screening and prep works complete (source)
5. 🔲 THEN, we want to see ILA start animal trials (pivotal trial) for Marburg disease. (this is the big one)

Here are the milestones we will be tracking for the animal study:

• 🔲 Clinical trial design completed
• 🔲 Clinical trial starts
• 🔲 Clinical trial completed
• 🔲 Clinical trial results

Assuming the clinical trial results are positive, ILA will then submit to the FDA for a New Drug Application (NDA) 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)

Again... IF APPROVED…

ILA COULD SECURE a Priority Review Voucher, which is a tradeable asset (which have traded at around ~US$200M of late).

(source)

AND/OR, ILA COULD SECURE commercial stockpiling contracts with the US Department of Defense for protection against bioweapons.

As mentioned earlier, some of these can have lifetime deals >US$500M:

(source - stockpiling deals the US government has done for other Category A bioterror threats)

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?)

See our latest ILA article for more on this: ILA ramping up drug manufacturing to help fight “worst ever” Ebola outbreak

🔄 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 this quarter, screening and prep works for the USAMRIID complete) (source)

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)