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A depressing update on Coya and Treg therapy; yet another company dragging its heels

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    A depressing update on Coya and Treg therapy; yet another company dragging its heels

    Some sad news drifted into my inbox today. Coya, a US based company known as a leading exponent of treg infusions to slow ALS progression, has confirmed that it is no hurry to get its treatment into the hands of actual ALS patients.

    The company had already been making what will feel to most ALS sufferers gratingly slow progress through its clinical trials, with a first small phase 1 trial conducted by Stanley Appel (before Coya were even involved, iirc) some years ago (I think 2017, but may have been ever earlier), showing slowing of progression in 3 participants.

    The company then made the strange (from a point of view of urgency) decision to do a phase 2a rather than a more traditional higher powered phase 2 (which would likely have been able to get them conditional FDA approval had it been successful) with just 8 participants. Again, good disease slowing was shown although there were a few non-responders. This was completed in early 2021. It took them over a year to publish the results.

    Then the CEO gave a spate of interviews talking positively about an imminent phase 2b, and speaking cultishly to an interviewer about funding pouring in and there being no need even for ordinary people to donate to it, since everything was covered.

    Well... According to the latest piece from Renaissance Capital, the reality is something quite different. In fact, Coya does not seem to have these funds to hand (another article says it's $9m dollar in debt) and is actually relying on an impressive uptake from its IPO, scheduled to go live shortly.

    The phase 2b trial, furthermore, will enroll no more than 12 participants (so will simply not be large enough to get conditional approval from the FDA or early approval from other bodies e.g. the EU) and won't start until 2024, so at least a year away.

    The upshot is that even if this study shows great results, on current trends, it will be at least 5 years until Treg therapy is available for ALS patients (since they'll have to do a further phase 3), within which span almost all of the crop of current patients, and a good deal of the next generation will have died.

    And this is a treatment that has some really positive early data, and whose efficacy as a strategy is backed up by the recent (albeit only mildly) positive results from the Mirocals IL2 trial (incidentally, Coya actually use IL2 to stabilise and ''buff up' their tregs).

    I'm sure that the company hasn't actually told any hard lies in interviews about its product or timelines, but I don't think I'm alone in getting the impression that their therapy and the progress of the company was much further along than it actually seems to be. It's also so deflating that the company which makes a big show of having some ex-ALS carers among its staff and whose CEO claims to have had 'personal experience' of neurodegenerative diseases among his relatives, is moving at such a glacial pace.

    These companies need to be bold and brave, to understand the urgency of the ALS clock and act accordingly. Instead, we get Captain Caution, with the saving of real lives seemingly sacrificed to protecting the bottom line.

    ‚Äč

    #2
    Thanks for the update. Such sad news.
    when i can think of something profound i will update this.

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