Will the FDA approve a disease-modifying treatment for Parkinson's disease before 2029?

The question resolves as Yes as soon as the FDA approves a disease-modifying treatment for Parkinson's disease.

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This month, two phase 2 trial results published: Roche's alpha-synuclein targeting prasinezumab showed motor benefits in some subgroups, and repurposing of lixisenatide might slow down the progression of motor symptoms.

Positive results for the Phase 2 trial of lixisenatide: https://cureparkinsons.org.uk/2023/08/preliminary-phase-2-trial-results-of-lixisenatide/

Next year: exenatide phase 3 results:

  • "The recent LixiPark study was much larger than the exenatide pilot study and involved 21 research centres across France; the LixiPark study results replicate the earlier exenatide results. There is now a large, multicentre phase 3 clinical trial of exenatide for Parkinson’s being run across the UK, and the top-line results are due to be reported in the second half of 2024."

Also promising, with results in the next couple of years:

  • Nicotinamide riboside Phase 2

  • Buntanetap

  • Ambroxol phase 3

Full pipeline: https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd239901

Stem cell therapy is at an early stage and won't make it before 2029 I'm afraid but it looks very promising:

Moreover, as noted by the above paper, not all of them are DMTs: "Cell therapy trials fall into two groups, those aiming to surgically implant stem cells into relevant brain regions; and those using stem cells delivered intravenously. The rationale behind the latter group is that such stem cells are the source of molecules that may influence the course of disease progression, and thus were classified as DMTs. The implanted cells aim to restore dopaminergic function and were therefore classified as ST. Most of these trials are at an early stage in Phase 1. Many of the cell therapy trials currently active were listed in our 2020 report underlining the long duration of cell therapy trials."

predicts YES

@adssx thanks. I've been following buntanetap. /StrayClimb/will-buntanetap-from-annovis-bio-re

25% seems high given the horrible base rate.

predicts YES

@StrayClimb I don't know enough about Buntanetap.

Of course, the base rate is 0% so far (approved DMT), but for this question, I'm looking at the overall pipeline (the same article that you linked) and the trends: more and more DMT trials (63, +10% in 3y), especially in phase 3 (6, +100% in 3y).

As a matter of comparison, for Alzheimer's:

  • In 2002: 1 DMT, none in Phase 3

  • In 2012: 24 DMT, including 10 in Phase 3

  • 10y later: 111 DMT, including 24 in Phase 3

I cannot find the data, there were probably about 100 DMT phase 3 trials (in total) before aducanumab and lecanemab got approved (for better or worse, that's another story) respectively in 2021 and 2023. So in terms of the number of DMT trials, Parkinson's research is where Alzheimer's was 10 years ago. So if Parkinson's follows the same trends we can hope for one FDA approval in about 10 years. I think that 1/ Alzheimer's is more complex than Parkinson's (in terms of disease but also in terms of operations to run trials as patients are older and demented for instance), 2/ the DMT pipeline is huge in phase 1 and 3/ the growth is impressive so I would bet that development will be faster for PD than for AD. Also, PD research can leverage learning from AD research.

That's why I voted yes. Although I think 2029 is a bit early.

predicts YES

@adssx Yeah. ANVS (producer of buntanetap) stock down ~50% in the last couple quarters. Nobody knows what's going on with it but patient reports from various forums don't seem inspiring