CU6 - Media and Industry News, page-761

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