Question on expansion trial for cushings | CORT Message Board Posts

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Msg  2724 of 2747  at  8/5/2019 8:20:47 PM  by

i760


 In response to msg 2723 by  BSR_Alan
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Re: Question on expansion trial for cushings

Thank you Alan.  I missed that small (8 subject) trial with Kormlyn.
  https://clinicaltrials.gov/ct2/show/NCT01990560
 
Interesting that the trial defined "mild" based on small elevation in cortisol along with a benign adrenal tumor (on imaging) and having concurrent evidence of diabetes or abnormal glucose tolerance.  For Relacorliant I would guess they add glucose and/or elevated BP. 
 
Interesting that they saw a clear effect on fasting blood glucose and other secondary endpoints in 6 mos (results up on Clinical Trials).  Hence the 6 month randomized design of the new mild Cushing's P3.
 
Maybe they let this go with Kormlyn since the side-effect profile of Kormlyn was too ugly for getting commercial traction (beyond the off label use) or FDA label expansion.
 
 
With Relacorliant they have much easier tolerability along with a larger customer base (as Rela showed effects both Glucose and BP subjects) and would think FDA would not have any issue with a broader label if the P3 reads positive (on similar glucose and BP endpoints as the regular Cushing's P3 trail).
 
Thank again Alan as all of above makes the "mild Cushing's" potential quite interesting. 
 
As an aside found laughable that in last note the BAML analyst thinks that enrollment speed of Corcept trials (and that of its competitors) is a good proxy for Cushing's market size....huh ?
 



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Msg # Subject Author Recs Date Posted
2725 Re: Question on expansion trial for cushings BSR_Alan 3 8/6/2019 10:53:14 AM


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