NYL01

[Rapiedog]

Have you heard about NYL01 trials? Sounding hopeful. Need people diagnosed but untreated.

[sharoncrayn]

Phase 2 is underway to assess this peptide which might be able to replicate positive results from earlier mice studies.

I assume we might see some results posted by 2022-2023.

Somewhat of a replay (and the theory) of the drug Exenatide (primarily in use for type 2 diabetics) for use with PD.

Sharon

[jimcaster in reply to sharoncrayn]

Sharon, do you think there's a chance of success (i.e. that disease progression may be slowed or stopped) through this particular trial?

[sharoncrayn in reply to jimcaster]

My take is that this peptide (which needs to be injected and refrigerated as do all peptides) is somewhat of a replay of the theory that diabetic drugs (Metformin for example or Exenatide) may allow for the slowing of PD's progression.

The Phase 1 results were nothing spectacular showing an improvement of 7 points on the UPDRS scale, (not sure what part or parts) which is equivalent to about a 5% improvement over the placebo.

Because I consider this Phase 1 CT an "intrusive/hawthorne" CT, (which leads to confounding effects due to the injection ... a la DBS surgery or an IV CT) I would consider this result a "wash".

Therefore, I have my doubts whether this peptide is the answer regardless of the optimism of the lead investigator.

(The Phase 2 design and participant level will offer sufficient validity)

Sharon

[sharoncrayn in reply to jimcaster]

In short, the phase 2 would have to show a "significant" CID of 10-12 points on part 3 (motor) and 16-20 on the total UPDRS.

Phase1 failed to achieve this level. If you do the math, phase 2 has to really out perform phase 1 results to be considered a "success".

[Hidden in reply to sharoncrayn]

Have you a link to the phase 1 results? I thought it was just a trial of safety in healthy subjects?

[sharoncrayn in reply to Hidden]

Check or call Neuraly or Dawson at Hopkins. Their mice study was published in Nature sometime in 2018. Don't see anything about Phase 1 results as of 2020.

Comment:

You are correct. Phase 1 WAS A PURE SAFETY TRIAL. However, They never filed a phase 1 result report on their results with single and multiple dose cohorts. Therefore, we must assume they encountered only a limited number of AEs. Presumably. (I believe some of the researchers have a "vested" interest here, so who knows?)

Their theory is somewhat suspect given Exenatide and its cousins have been examined before (see Foltynie in the UK in his Phase 3 due 2024 completion) in terms of PD and GLP-1R, and because of its "new"mechanism of action versus Exenatide type drugs. i.e with NYL01 reactive astrocytes seem to be critical to the neuronal cell death.

Thanks for the heads up though. My mistake here. Somewhat confused this peptide with CuATSM results and Sean Lamb. Too many drugs and trials rattling around in my brain.

Sharon

[sharoncrayn in reply to jimcaster]

oops. CID = clinically important difference