CTP-543 - Phase 3 THRIVE AA1 Results

Today Concert Pharmaceuticals released the first of two phase 3 clinical trials for the unmet medical need Alopecia Areata.  The results were impressive and mirrored their phase 2 clinical trial. The phase 3 had 41.5% of patients in the 12 mg group achieving the SALT 20 or lower score after 24 weeks of treatment. Note that the lower the SALT score the more head of hair that has grown back.  The percentage of the 8 mg group of patients achieving a SALT score of 20 or less was 29%. Adverse events were reported inline with their phase 2 clinical trial. Below are results from three companies targeting Alopecia with their respective drugs. 

Concert's CTP-543 (green bars in graph) is the most effective in the high dose of 12mg and their lower dose of 8mg versus the others, high and low dose. The second phase 3 THRIVE AA2 will read out in the third quarter. Thank you for reading.

 

CTP-543 - Patent Trial and Appeal Board Decision

Yesterday the PTAB (Patent Trial and Appeal Board) ruled on a PGR (Post Grant Review) in favor of Concert Pharmaceuticals. The petitioner Incyte Corporation, has not demonstrated beyond a preponderance of the evidence that each challenged claims is unpatentable. Incyte Corporation could appeal to the Federal Court system, but that can take several years to play out, and may come to the same conclusion that the PTAB just did.

CTP-543's patent runs to 2037, so plenty years ahead, even considering that Concert does not plan to submit a New Drug Application to the FDA until the first half of 2023, with expected approval, either end of 2023, early 2024. 

CTP-543 would be addressing the unmet need of Alopecia Areata, an autoimmune disorder that causes your hair to come out, and which there is not an FDA approved oral treatment available at this time. Phase 3 clinical trial Alopecia data from Concert is expected in the coming weeks. Concert's stock had a positive reaction to this news, chart below. Thank you for reading.