Saturday, November 17, 2018

CTP-543 and PFE-06651600

Now that Concert Pharmaceuticals has press released their top line results for CTP-543 8mg twice daily, CTP-543 Results from Interim Analysis of Phase 2a Trial in Patients with Alopecia Areata, a comparison can be made with Pfizer's  phase 2 results for drug PFE-06651600 for moderate to severe Alopecia Areata. In the comparison below, I am focusing on SALT % Increase (mean) End of Treatment. In this category CTP-543 had a 42.00% mean increase of SALT score after 24 weeks, versus a 38.13% increase for Pfizer's drug PFE-06651600. Concerts phase 2 study testing up to 8mg, may not be the highest dose available, as the company is currently testing a 12mg arm in the same phase 2 study.
PFE-06651600
Total (n=45) 24 weeks
  Baseline End of Treatment
SALT (mean)  88.1 54.5
SALT Increase (mean) -33.6
SALT % Increase (mean)    0 38.13%
% SALT Reduction   % of 45 Patients Achieving Better SALT Scores
30% 47.9%
50% 37.5%
75% 27.0%
90% 25.0%
100% 12.5%
CTP-543 8mg
Total (n=38) 24 weeks
  Baseline End of Treatment
SALT (mean)  89.1 51.7
SALT Increase (mean) -37.4
SALT % Increase (mean)    0 42.00%
% SALT Reduction   % of 38 Patients Achieving Better SALT Scores
30% not measured
50% 47.0%
75% 29.0%
90% 16.0%
100% 0.0%

Friday, November 2, 2018

FDA Advisory Committee Votes 17-1 in Support of Zulresso for PPD

Today the Advisory Committee (ADCOM) voted 17-1 in support of Sage Therapeutics drug Zulresso for Postpartum Depression (PPD). The first and only drug if approved for this unmet medical need, will go into commercialization early 2019 under the name of Zulresso. The press release is here FDA Advisory Committee Votes 17-1. 
The future for the company gets even more exciting with once daily oral drug SAGE-217, which is in phase 3 testing for Major Depressive Disorder or MDD, and has a market potential several times larger than PPD.
SAGE has a talented management team, with plenty of cash to run pivotal clinical trials, and bring new drugs for other indications to market. SAGE-217 has patent to April 2034. Thank you for reading.