Where acceptance is all there is
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?
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.
I think that if they made for alopecia areata the sides effect no very important
was curious about this so I started googling
phase 1 testing returned positive results, phase 2 testing starting in 2017.
JAK inhibitors are a medical breakthrough that have potential to help with a lot of autoimmune disorders. There is reason to be very optimistic.
unfortunately it looks like phase 2a testing has been delayed until later this year
I'm not entirely sure what "clinical tablet appearance issue" means, but I guess it means the trial is delayed
they are looking for trial patients!
So this is a modified version of Ruxolitinib, does anyone know if it was modified in a way to make it safer in regards to possible harmful side effects?
I want to try it. How long does it take for results?
discouraging. although it's not a deathblow yet, just the FDA wanting to do a bit more review. Hopefully it's not a drawn out process!
E)-- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its CTP-543 Phase 2a clinical trial for alopecia areata has been placed on clinical hold. The FDA had previously informed the Company that it could initiate the Phase 2a clinical trial; however, subsequent to its initiation, but prior to dosing subjects, the FDA informed the Company that a review of certain recently completed non-clinical toxicology studies is required before proceeding. The FDA did not cite a safety concern; however, they intend to review these additional non-clinical data as support for the one-year dosing duration as planned in the Phase 2a trial.
At the request of the FDA, the Company intends to submit the requested non-clinical study reports promptly. By regulation, the FDA has 30 days from receipt of Concert's response to notify the company whether the clinical hold is lifted. Concert is working diligently with the FDA to resume enrollment in the Phase 2a trial as quickly as possible.