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Ann: Quarterly Activities & Cashflow Report, page-5

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ma420

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17/08/24

20:26

Post #: 75253535
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Originally posted by Teeth: ↑

Attempting to respond to your question from the Ann: ISLA-101 Phase 2a/b clinical trial progresses thread. My account seems to be playing up and won't let me respond to your question there.

I'm not sure of the wording to your first question. Do you mean healthy individuals in a clinic with attenuated virus vs real life patients out in the world with a wild dengue virus?

My understanding is both a and b are in healthy individuals (at least prior to infection), running back to back.

Phase 2a is prophylactic. ISLA-101 taken for 4 days prior to inoculation with the DENV-1-LVHC attenuated virus, and for 21 days after. Dosing begins Oct 1. Results expected before end of CY.
Phase 2b is therapeutic. Subjects to be infected with DENV-1-LVHC day 1, ISLA-101 administered day 8 with 2 doses a day through to day 21. Dosing begins Jan 2025, and I assume results within the same sort of time frame as 2a.

The results from this will inform the next trial, which according to David Foster is most likely a therapeutic study in an endemic country, subject to conversations with the FDA. He also expects partnering conversations to ramp up once Phase 2 data starts coming in.

I couldn't find anything mentioned officially on accelerated approval.

While we're in this thread, I'm also curious about funding. I did start buying in recently though.

Edit: Posting here works but wouldn't in the other thread. Attempted from 2 different browsers on PC and from mobile. Bizarre.

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Thanks for your detailed reply mate. So when will they test in actual Dengue patients- phase 3? Or will they conduct a second phase 2 trial in real patients? Any idea?

ILA Price at posting: 6.5¢ Sentiment: None Disclosure: Not Held
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Ann: Quarterly Activities & Cashflow Report, page-5

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