PYC Therapeutics Limited

ASX:PYC

PYC Therapeutics Limited

ASX:PYC
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$1.820 (-0.5%)
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#190
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Forum Topics PYC PYC Announcement

Pinned straw:
Scoonie
Added 3 months ago

What is it Scoonie?

PYC released their results for the 75 microgram dose patients stating:

“PYC today announces an improvement in vision in 2 additional patients with RP11 after they received a single 75 microgram dose of VP-0012”

“Two out of the three RP11 patients in this cohort had enhanced retinal sensitivity across the entire macula at 3 months of follow up when compared to baseline.”

Also: “the third patient in cohort 3 of the SAD (whose results were not included in the announcement of 5 August because they did not undergo microperimetry assessment at 3-4 months post-dosing) completed their 6-month follow-up visit including assessment on microperimetry. The results show a marginally slower rate of disease progression in the treated eye (-0.5 dB) when compared to the untreated eye (-0.7 dB) on whole grid mean retinal sensitivity at this time-point.”

Yeah, all sound all fine and dandy. But, notice how the reporting format was not the same as the results released on the 5/8/24. They did not report on Scotomas number reduction,  nor did they report these results as being  ‘clinically significant’ with reference to FDA  blinding eye disease endpoints.

I told you multiple times, but you won’t listen, your on a complete loser mate.  These things go along fine and then, crack, the whole ship springs a giant leak and sinks like a rock.

Agree, whilst today’s results are positive, you make a valid point. Today's reported results are a lesser outcome than might have been expected. Given the very positive outcomes from the 30 microgram dose you might have expected a much improved results from a doubling of the dose.   

And all that stuff about them “preparing for a registrational trial, scheduled to commence next year” is just puss. There to fill up the pages and make everything look on good.  Get out of it you moron while you are still in front.

Maybe, it is early days. There are the Multiple Ascending Dose readouts to come between now and the end of the year and the Single Ascending Dose Part B extension readouts. In addition, there is the near-term wider program consisting of Autosomal Dominant Optic Atrophy (readouts in 2024 and 25), Autosomal Dominant Polycystic Kidney Disease (animal readouts in 2024, human readouts in 2025). These is around $100m cash runway to fund the program this year and into 2025.

Hope springs eternal. Fool.

mikebrisy
Added 3 months ago

@Scoonie you appear to be following this one quite closely. The blow-by-blow reporting of progress on a trial seems a bit odd to me. I'm more used to seeing an entire trial (or major phase of a trial) completed followed by an "initial read-out" of the overall results compared with the objectives, focusing on key endpoints, with perhaps then a more complete report when the detailed analysis is completed, which can be a couple of months later. Of course, doing the initial read-out is critical, because of the risk that the progress of the trial leaks out via those with sight of the results.

The $PYC result has been flagged as price sensitive, but I am not convinced that it is. If anything, the market considers it sensitive in a negative direction on a day which is very much "risk on" for biotechs.

You've kinda hinted at this with your observation that the basis of the report is slightly different to the last one (i.e., are the reports cherrypicking news?). What's your view of management's approach here?

I ask being someone who is less familiar at the more speccy end of biotech and more across products in the early commercialisation phase.

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Scoonie
Added 3 months ago


@ mikebrisy  PYC is has a lot happening so I will confine my comments to today’s announcement.

PYC’s most advanced drug in development is for the treatment of Retinitis Pigmentosa Type 11. They have been running two arms to the Ph1/2 trial, and reporting at each staged readout. The numbers of candidates at each stage are typically small at around 3.     

These are single Ascending Dose Trial (SAD) and a Multiple Ascending Dose Trial (MAD). Typically there is a readout at a 3 - 4 month intervals. No doubt they have structured this way since they are concerned at each step with patient safety as well as efficacy.

However, the question would have to be put to PYC why they have not retained the data from each of these staged readouts and released as one announcement at some end point. I suspect the issue of confidentially as you have indicated is a factor.   

The results announcement on the 5/8/24 with a single dose of 30 micrograms of the drug was described for two of the three patients as: “…. considered to be ‘clinically significant’ on this endpoint by the US Food and Drug Administration in the context of blinding eye diseases”

Today’s announcement related to 3 patients receiving a single 75 microgram dose. PYC described the outcome for two of the patients as: “………..enhanced retinal sensitivity across the entire macula at 3 months of follow up when compared to baseline”.

There was no mention of todays announced results being FDA endpoint  “clinically significant” for the two positively reporting patients. Nor did they report a reduction in baseline number of scotomas (blind spots) as they did in the announcement of the 5/8/24.

Whatever conclusions you like can be drawn from the above. However they do not appear as positive as you might expect, given the earlier seemingly more positive results were reported at a lower dose. 

 I have put the above considerations to management and will advise if I get a response. 

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