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Originally posted by ttppxx: ↑

IS THIS THE NEXT NEWS FLOW TO SAVE US?

In DISCO we must TRUST! - The results are expected any minute now!

DISCO:⁶⁴Cu-SARTATEversus ⁶⁸Ga-DOTATATE (Standard of Care) on Patients With Known or Suspected NETs

BACKGROUND
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, affects many organs including the gastrointestinal tract (GI) (60% of all cases), bronchopulmonary tree (27%), and the pancreas,biliary tract, liver, ovaries and testes, etc.
Annual incidence: around 7 cases per 100,000.
A delay in diagnosis or misdiagnosis is common: 30-75% of NETs patients have distant metastases at the time of diagnosis.
DISCO is a Phase 2 study, following a Phase 1 that was completed in 2016. In that earlier study: the performance of Clarity's ⁶⁴Cu SARTATE was equivalent to SOC at 1 hour, and superior at 4 hours. There were no safety concerns.
DISCO: A Phase 2 trial, that originally planned to recruit 63 patients. 45 patients were recruited instead, and the final patient assessment was completed in Oct/November 2024!

And yes, the Christmas holidays are over!

READING BETWEEN THE LINES (I am embarrassed to be acting wise coz this is not even a secret!)! Anyhow;
a) The original plan was to recruit 63 patients, based on an 'expected discordance level' between imaging with Clarity’s ⁶⁴Cu-SARTATEand the current standard of care, ⁶⁸Ga-DOTATAT!
b) Following a sneak peek (planned early assessments) at the images collected, the sample size was adjusted to 45 patients, allowing for early trial completion!!! This is SIGNIFICANT: it indicates that, either, the discordance level is larger than originally thought 9hence no need for more patients to prove it (VERY GOOD), or that there is no difference at all so no point continuing (VERY BAD)!
c) While an early stoppage can indicate failure (futility), an example result (a sample of what should be inside) was provided during the last update (Fig 1), together with the following comment from the company; “We believe that SARTATE has the potential to become a best-in-class product in this indication, and other indications that have the same target receptor,SSTR2 ….”d) The results on the Table are telling: ⁶⁴Cu-SARTATEis superior to SOC, by a wide margin, when all we may need for approval is equivalence!

d) This trial was meant to collect enough evidence to guide planning for a Phase III trial in NETS! This would become a 3rd Phase III trial for Clarity if it were to commence in the next several months. I do not know if that's the plan though: The theranostics trials in Neuroblastoma seem to be of higher priority - perhaps influenced by the RPDD and ODD?

FLEXIBILITY vs CONVENIENCE: While we are there, lets note that Ga68 imaging is done at 1 hour only, while Cu64 based imaging can be done on the same day: 1 hour, or at 4 hours for a better image (almost 2X better), or even next day for even better images (4X better). It is important to note that this is not a convenience matter: Ga68 products have an inherent disadvantage: they are like ice; once made, they begin to melt away. Image NOW or lose it!

As a Long Term Investor, I find knowing and understanding my investment quite useful when the going gets tough - like now! I compare this investment with the other products that I am invested in: Clarity is a known entity, following well defined footsteps, in a well defined industry, with superior products to those that have come before! A real upgrade! Not that I have little faith in the management, but I think its going to be really hard for them to stuff this one up!

Good Luck to All Long Term Holders and Short Term Traders!

REFERENCES
1) Last patient assessment completed for diagnostic SARTATE trial in NETs: https://www.claritypharmaceuticals.com/news/disco-lplv/
2) An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours: https://clinicaltrials.gov/study/NCT04440956

Expand

OTHER NEAR-TERM MILESTONES THAT I AM LOOKING FORWARD TO (this H1 of 2025)

1) CLARIFY Diagnostic Trial: 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (Phase 3)
- Started 30/11/2023
- Estimatedcompletion in Feb 2025
This is a pivotal Phase 3 registrational trial! There will be a visit to the FDA for an important discussion! Who knows what's gonna come out of it!!
And, yes, the results should be just as we have seen before in PROPELLER! Best in class is the word.
# The FDA like what they have seen: Fast Track Designation granted, meaning that this product offers an advantage to existing therapies!
# The secret is truly not a secret!

2) AMPLIFY Diagnostic Trial: 64Cu-SAR-bisPSMA in patients with biochemical recurrence BCR of prostate cancer (Phase 3)
- This trial is being planned. It will be Clarity's 2nd pivotal Phase 3 registrational trial!
- The FDA has given positive guidance! We need to recruit 220 prostate cancer patients!
- Recruitment expected tocommence in early 2025!
NEXT:FIRST patient dosed announcement (or will it be ethics approval gained, or sites activated, etc?)
# And, yes, the results should be just as we have seen before in COBRA!
# Its the same product that the FDA have liked: FDA’s Fast Track Designation granted!

3) The CLICK CHEMISTRY Trial: PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in Peoplewith Pancreatic, Bladder or Colorectal Cancer or Solid Tumors with ElevatedCA19.9 Levels
- A Phase 1 trial, with a target of 22 patients. https://clinicaltrials.gov/study/NCT05737615
- Estimated Completion - Feb 2025
There has been radio silence on this one since the first announcement (unless I missed something), but I think it will be something special coz the science is exceptional: the inventors were awarded the Nobel Prize in Chemistry in 2022!

REFERENCES
64Cu-SAR-bisPSMA - Next-generation diagnostic for patients with prostate cancer; https://www.claritypharmaceuticals.com/pipeline/sar-bispsma/64cu-sar-bispsma/
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY); https://clinicaltrials.gov/study/NCT06056830?cond=PROSTATE%20CANCER&term=CLARIFY&rank=1
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer; https://www.claritypharmaceuticals.com/news/fda_amplify/
Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA; https://www.claritypharmaceuticals.com/news/fast-track/
Clarity bolsters antibody pre-targeting with IP from leading global cancer center; https://www.claritypharmaceuticals.com/news/pre-targeting/