ILA secures FDA meeting on Galidesivir fast-track pathway

Our biotech Investment Island Pharmaceuticals (ASX: ILA) just announced it has secured a meeting with the FDA.

ILA has recently acquired the anti-viral drug Galidesivir and is now exploring its potential use in treating Marburg Disease, a virus with an 88% mortality rate and no approved treatments.

To progress development, ILA plans to pursue the “Animal Rule” pathway.

This is a little known FDA process designed to fast-track drugs for life-threatening conditions, particularly those linked to bioterrorism and bioweapon threats.

If Galidesivir proves effective against Marburg and secures FDA approval, ILA believes it could generate $200M–$500M in cash within 12 months, driven by:

• A Priority Review Voucher (valued in the hundreds of millions)
• A potential government stockpiling contract for bioterrorism defence (also worth hundreds of millions)

We listed the steps on how ILA can get there in our last note here: $68M capped ILA - $200-500M revenue in the next 12 months…. How?

• FIRST, The FDA will need to allow the use of the Animal Rule for ILA to fast track its drug to market (the FDA meeting to find this out is expected to occur next quarter)

Update: This is where today’s news fits in. It's expected that by November 12 (US time) that ILA will receive a written response and will prepare a briefing ahead of that meeting.

• THEN, ILA will need to conduct a short, low-cost clinical trial on non-human primates (trial expected to cost circa $4M. ILA held $7.25M cash at June 30 so is funded for this) to evaluate if its drug is effective at treating Marburg disease.

Update: ILA confirmed today that it was in discussions about the animal studies and expected them to start and be completed all inside the next quarter.

• THEN, Submit to the FDA for an IND approval of its drug (6 month review timeframe)

IF APPROVED…

• SECURE a Priority Review Voucher, which is a tradeable asset worth on average ~US$150M (think of this like a ‘thank you’ for developing the drug - more on this later)
• SECURE commercial stockpiling contracts with the US Department of Defence for protection against bioweapons. These contracts can be very lucrative. You can see examples of contract size and duration in this webinar - (in summary they are all worth six figures and some are rolling contracts.)

We will be listening into the webinar with management today AT 11:00AM AEST (9:00am AWST) to get the latest on how that process will play out:

Click here to register for the webinar

What’s next for ILA?

Animal trial for Marburg Disease

Now that ILA has completed the acquisition of Galidesivir, we want to see the company work with the FDA to develop an animal trial to determine efficacy on Marburg Disease.

🔄 FDA meetings to determine the application of the Animal Rule.

🔲 Clinical trial design completed

🔲 Clinical trial starts

🔲 Clinical trial completed

🔲 Clinical trial results

We think this should be a fairly quick process assuming ILA gets a favourable FDA Animal Rule outcome and it doesn't need to run trials in humans.

(Source)