New JAK inhibitor - CTP-543 by Concert Pharmaceuticals

this new drug was mentioned in the Xeljanz thread but I thought that since it's so difficult to keep track of information on the format of this forum it should have it's own thread

Can we try to keep this thread on topic with any information about CTP-543 that anyone happens to come across? 

http://www.businesswire.com/news/home/20160504006458/en/Concert-Pha...

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced its next product candidate, CTP-543, for the treatment of alopecia areata. Alopecia areata is an autoimmune disease characterized by patchy or widespread hair loss, for which there is significant unmet medical need and currently no FDA-approved treatment. CTP-543 is a deuterium-modified analog of ruxolitinib, which selectively inhibits Janus kinases 1 and 2, known as JAK1 and JAK2. Ruxolitinib is commercially available under the name Jakafi® in the United States for the treatment of myelofibrosis and polycythemia vera. Concert expects to initiate Phase 1 clinical evaluation of CTP-543 in the second quarter of 2016 with efficacy studies commencing in 2017.

Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been shown to promote hair growth in individuals with moderate to severe disease. Preclinical studies conducted by the Company demonstrated that CTP-543 retains ruxolitinib’s selective JAK 1/2 inhibition profile and shows improved metabolic stability.

“We are very excited about the potential of CTP-543 to greatly enhance patient care for individuals with alopecia areata. CTP-543 represents an opportunity to address an important disease where new and effective treatment options are needed,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “Based on demonstrated clinical activity of ruxolitinib in alopecia areata, CTP-543 has the potential to become an important first-in-class oral medicine to treat a devastating condition affecting millions of people in the U.S.”

Recently, the U.S. Patent and Trademark Office issued U.S. Patent No. 9,249,149 that claims CTP-543 as a novel composition of matter.

“CTP-543 is a prime example of the application of our deuterium platform to create proprietary new medicines which enhance and extend the utility of known molecules into new therapeutic areas. We believe we have developed a valuable, potentially first-in-class new drug candidate for an important unmet medical need and look forward to advancing CTP-543 into clinical evaluation shortly,” said Dr. Tung.

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Permalink Reply by ashes1120 on September 25, 2018 at 1:15pm

That’s me!! 100% AU to now 100% growth from phase 2a of trial! I just made the switch to xeljanz 3 weeks ago and still so far so good!! If anyone has any questions feel free to reach out! 

Permalink Reply by Nor75 on September 25, 2018 at 3:33pm

Thank you, ashes1120! Did you experience any issues side-effects? 

And what was your SALT score after completion?

Permalink Reply by Nor75 on September 25, 2018 at 5:21pm

Sorry, just noted your score 100 vs 0 after completion, 

Permalink Reply by singh on September 25, 2018 at 4:38pm

Wow that’s amazing to hear !! Can I ask how long was you on CTP-543 in total ? To get full regrowth?

And how long have you been AU for? 

Thank you !

Permalink Reply by singh on September 25, 2018 at 5:10pm

Any chance of a before and after pic ? This is exciting for the likes of people who have not responded to the traditional jak-inhibitors.

Thank you the update!

Permalink Reply by ashes1120 on September 25, 2018 at 5:22pm

24 week trial, last 4 weeks is drug free. Only side effects I really had were increased cholesterol and a little weight gain. AU since May 2016

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Permalink Reply by singh on September 25, 2018 at 5:37pm

Wow ! Amazing ! Congratulations on your results very exciting ! Thank you for posting! 

Am guessing your eyebrows grew back ? Can I ask did anyone not respond in the trial ?

Permalink Reply by Sad_Rapunzel on May 22, 2019 at 5:15pm

absolutely unbelievable... only 24 weeks.. 

Permalink Reply by serg navaro on September 27, 2018 at 1:22pm

So are you on xeljanz to maintain what you grew back? Is it necessary or just being cautious?

Ive been on Xeljanz for almost 2 years now with slow regrowth

Permalink Reply by singh on July 2, 2020 at 5:07pm

Any Updated on CTP-543 people ? I’ve heard it has been fast tracked by the FDA? What does this mean ?

Thank you 

Singh

Permalink Reply by Fred on July 2, 2020 at 7:06pm

The phase 3 trial for the drug is about to kickoff in Q4 this year. 

It’s a 24 week trial. Hopefully they will be filing with the FDA sometime next year. 

Permalink Reply by singh on July 5, 2020 at 10:47am

Thanks Fred,

Ive heard has been fast tracked through the FDA... what does this mean?


I know Pfizer’s PF-06651600 jak for alopecia has been in phase 3 since June 2019 but there saying the phase won’t end until May 2023 so not sure how that might get approved before CTP-543 as they still need to start a phase 3 trail ?

Kind regards 

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