ILA receives “no adverse feedback” from the FDA for its Marburg disease drug
Our 2025 biotech Pick Of The Year Island Pharmaceuticals (ASX: ILA) just received “no adverse feedback or additional data requests” from the FDA.
ILA is developing an antiviral drug (Galidesivir) to treat Marburg disease.
Marburg virus is classified as a Category A bioterrorism threat (the highest level threat) by the US government (source).
ILA recently got approved for a fast tracking avenue utilising the “Animal Rule” and a valuable Priority Review Voucher.
The animal rule process allows ILA to skip a 15+ year, expensive process of human phase 2 & 3 clinical trials and instead go for FDA approvals based on animal data alone.
(Source)
Basically the animal rule process is FDA’s pathway for approving drugs for diseases where human trials wouldn't be ethical to run.
We note ILA’s drug (Galidesivir) has already had one smaller animal trial completed showing a 94% survival rate versus placebo:
(Source)
To satisfy the animal rule process ILA needs to run the second animal study…
(more on the animal rule process in a second)
Before ILA starts trials, it is waiting for a final round of feedback on ILA’s drug development plan.
Basically ILA is waiting for the FDA to give the company the greenlight to kick animal studies off.
The final feedback round was initially expected on the 2nd of January, so we should hear back from the FDA soon…
Island Pharmaceuticals
ASX: ILA
Marburg is the only Category A biothreat with no current vaccine or FDA approved treatment…
It's also one of the most deadly with a fatality rate up to 88%.
It’s classified as a biothreat because it can be weaponised (and it was part of the soviet bioweapons program in the 80’s, (source, source).
While ILA awaits the final feedback, it is continuing preparatory activities, including discussions for non-human primate studies and engagement with US Government stakeholders.
We covered an update on this front relating to signing a Master Service Agreement (MSA) with Texas Biomedical Research Institute, we covered that in a Quick Take here.
Texas Biomedical Research Institute is one of only four research facilities in the US with the capability to conduct preclinical infectious disease research trials in non-human primates.
This directly relates to what ILA is aiming to achieve.
What is the Animal Rule?
ILA is going for approvals on the drug via a fast tracked “Animal Rule” approvals pathway - which is basically where biotech’s can seek FDA approvals for really deadly diseases on animal trials alone.
(Cutting out the 10-15 years of human trials needed for most drugs).
Read more about the animal rule here: How can ILA fast track approvals through the “Animal Rule”?
We are Invested in ILA to see it go through the animal rule process - get its drug FDA approved (fingers crossed).
Approvals for ILA (potentially inside the next 12-18 months) could unlock:
- A Priority Review Voucher (PRV) that comes in if ILA’s Galidesivir is FDA approved - these can be worth on average ~US$150M.
- US Government national stockpiling deals - these can be worth anything between US$100M to US$1.2BN ANNUALLY
We covered all of this in our most recent note here: ILA: Our Biotech Pick of the Year
What’s next for ILA
Mid November: ILA confirmed Animal Rule eligibility for its Marburg drug ✅
Mid December: ILA signs agreement with Texas Biomedical Research Institute (capable of running the trials/studies for ILA) ✅
NEXT: FDA provides feedback on ILA’s animal trial design and ILA confirms it will be using the animal rule FDA approval process for its Margurg disease drug.
NEXT: Commence animal trial for Marburg disease.
After that point we will be tracking the following milestones for the study:
- ✅ Deal signed with clinical trial research facility. (source)
- 🔲 Clinical trial design completed
- 🔲 Clinical trial starts
- 🔲 Clinical trial completed
- 🔲 Clinical trial results
NEXT: (Assuming results are good) Submit to FDA for commercial approval and access to Priority Review Voucher
