— FDA Requested Review of Recently Completed Non-Clinical Studies —
— FDA Did Not Cite a Safety Concern —
LEXINGTON, MA, USA I May 17, 2017 I 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.
About CTP-543 and Alopecia Areata
CTP-543 was discovered by applying Concert’s deuterium chemistry technology to modify ruxolitinib, a drug which selectively 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. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been reported to promote hair growth in individuals with moderate-to-severe disease.
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 and affects 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 U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata.
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 address unmet patient needs. The Company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, autoimmune and inflammatory diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com.
1 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.
SOURCE: Concert Pharmaceuticals
Post Views: 15
— FDA Requested Review of Recently Completed Non-Clinical Studies —
— FDA Did Not Cite a Safety Concern —
LEXINGTON, MA, USA I May 17, 2017 I 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.
About CTP-543 and Alopecia Areata
CTP-543 was discovered by applying Concert’s deuterium chemistry technology to modify ruxolitinib, a drug which selectively 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. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been reported to promote hair growth in individuals with moderate-to-severe disease.
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 and affects 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 U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata.
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 address unmet patient needs. The Company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, autoimmune and inflammatory diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com.
1 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.
SOURCE: Concert Pharmaceuticals
Post Views: 15
