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Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals, Inc. today announced that interim clinical data from its CTP-543 Phase 2 trial in alopecia areata will be presented in a poster presentation

Poster Presentation

Title: CTP-543, A JAK1/JAK2 Inhibitor, Achieves Primary Endpoint in Interim Analysis of Phase 2 Trial in Alopecia Areata
Date and Time: Thursday, April 25, 2019 at 11:00 a.m. GMT
Poster Number: P6
Location: Exhibition Area

Lecture Series

Title: JAK Inhibitor CTP-543: Interim Results from a Phase 2 Trial in Alopecia Areata
Date and Time: Thursday, April 25, 2019, 4:15 – 4:45 p.m. GMT
Session: Sponsored Lecture
Room: Auditori

About CTP-543

CTP-543 was discovered by applying Concert’s deuterium chemistry technology to modify ruxolitinib, a drug which inhibits Janus kinases 1 and 2 (JAK1 and JAK2) and is commercially available under the name Jakafi® in the United States for the treatment of certain blood disorders.

Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543.

About Alopecia Areata

Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body that may affect up to 650,000 Americans at any given time1. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp.

Onset of the disease can occur throughout life with the majority of patients initially having symptoms by age 40. It is believed to equally affect both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.

Following the FDA’s Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs.

The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

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Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

Concert Pharmaceuticals, Inc. today announced that interim clinical data from its CTP-543 Phase 2 trial in alopecia areata will be presented in a poster presentation

Poster Presentation

Title: CTP-543, A JAK1/JAK2 Inhibitor, Achieves Primary Endpoint in Interim Analysis of Phase 2 Trial in Alopecia Areata
Date and Time: Thursday, April 25, 2019 at 11:00 a.m. GMT
Poster Number: P6
Location: Exhibition Area

Lecture Series

Title: JAK Inhibitor CTP-543: Interim Results from a Phase 2 Trial in Alopecia Areata
Date and Time: Thursday, April 25, 2019, 4:15 – 4:45 p.m. GMT
Session: Sponsored Lecture
Room: Auditori

About CTP-543

CTP-543 was discovered by applying Concert’s deuterium chemistry technology to modify ruxolitinib, a drug which inhibits Janus kinases 1 and 2 (JAK1 and JAK2) and is commercially available under the name Jakafi® in the United States for the treatment of certain blood disorders.

Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543.

About Alopecia Areata

Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body that may affect up to 650,000 Americans at any given time1. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp.

Onset of the disease can occur throughout life with the majority of patients initially having symptoms by age 40. It is believed to equally affect both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.

Following the FDA’s Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs.

The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting

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CTP-543 alopecia

FDA Fast Tracks CTP-543 for Alopecia

FDA Fast Tracks CTP-543 for alopecia areata

Concert Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata.

The FDA grants Fast Track status for Concert Pharmaceuticals’  CTP-543 for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles resulting in hair loss.

Phase 2-stage CTP-543 is an oral Janus kinase (JAK) inhibitor discovered by the company by applying its deuterium chemistry technology to modify ruxolitinib (Incyte’s Jakafi).

FDA Fast Tracks CTP-543 for AlopeciaRuxolitinib has been used to treat alopecia areata on an off-label basis.

Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the marketing application.

Currently, there are no approved treatments for alopecia areata and CTP-543 has the potential to be a first-in-class treatment for this disorder. The drug candidate is being evaluated in a Phase 2a, multicenter, double-blind, randomized, placebo-controlled trial in adults with moderate-to-severe alopecia areata.

CTP-543 was developed by modifying ruxolitinib with the Company’s DCE platform (deuterated chemical entity platform).

Ruxolitinib is a selective JAK1 and JAK2 inhibitor that is currently marketed as Jakafi for the treatment of certain hematologic disorders.

Deuterium modification of ruxolitinib demonstrated a change in human pharmacokinetics that may make it an effective treatment option for this autoimmune disease.

This technology is thought to improve the metabolic profile and oral bioavailability, as well as increase half-life.

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