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Concert Pharmaceuticals to Provide Overview of Clinical Pipeline

Concert Pharmaceuticals to Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

Concert Pharmaceuticals, Inc today announced that it will be providing an overview of the Company’s clinical pipeline following recent updates on the AVP-786 partnered program in a presentation at the Cantor Healthcare Conference on Thursday, October 3, 2019 at 5:20 p.m. ET in New York, NY.

“While we’re disappointed by the recent results generated by our collaborators in the AVP-786 Phase 3 Alzheimer’s agitation trial, we are highly focused on the distinct value of Concert’s proprietary drug candidates, CTP-543 for alopecia areata and CTP-692 for schizophrenia,” stated Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals.

“We have had a consistent pipeline strategy to develop innovative medicines based on well-established biology, which is the foundation for CTP-543, a JAK inhibitor for alopecia areata, and for CTP-692, a deuterated D-serine which is an NMDA co-agonist. Concert’s financial resources are dedicated to these proprietary candidates, and our clinical programs are focused on demonstrated efficacy and safety for unmet needs in these chronic diseases affecting millions of patients.”

Dr. Tung continued, “For our partnered programs, including AVP-786, the clinical rationale and all development costs are the responsibilities of our collaborators.” On September 27, 2019, Concert’s collaborator, Avanir Pharmaceuticals, Inc., announced that the second study of its Phase 3 clinical program for AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s disease did not meet its primary and key secondary endpoints.

At the Cantor Healthcare Conference, Dr. Tung will highlight recent developments and upcoming milestones for Concert’s two wholly-owned clinical candidates during the presentation.

CTP-543: an investigational treatment for moderate-to-severe alopecia areata

In September 2019, Concert reported positive topline results from a recently completed Phase 2 dose-ranging trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata. CTP-543 achieved its primary endpoint in the 8 mg and 12 mg twice-daily dosing cohorts. Treatment with 8 and 12 mg twice-daily of CTP-543 for 24 weeks was generally well tolerated and resulted in significant hair regrowth and significant ratings of improvement in individuals with alopecia areata.

Concert plans to present the Phase 2 dose-ranging results in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Annual Congress on October 12, 2019 in Madrid, Spain.

Concert also initiated two open-label studies in 2019 evaluating once-daily vs. twice-daily dosing. Both studies are fully enrolled. Topline data from the first study is expected by year-end 2019 and the results from the second study are expected in the first half of 2020.

The CTP-543 development program is based on well-established biology that Janus kinase (JAK) signaling underlies the pathophysiology in alopecia areata.
The Company intends to advance CTP-543 into Phase 3 in 2020.

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 Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

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Concert Pharmaceuticals to Provide Overview of Clinical Pipeline

Concert Pharmaceuticals to Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

Concert Pharmaceuticals, Inc today announced that it will be providing an overview of the Company’s clinical pipeline following recent updates on the AVP-786 partnered program in a presentation at the Cantor Healthcare Conference on Thursday, October 3, 2019 at 5:20 p.m. ET in New York, NY.

“While we’re disappointed by the recent results generated by our collaborators in the AVP-786 Phase 3 Alzheimer’s agitation trial, we are highly focused on the distinct value of Concert’s proprietary drug candidates, CTP-543 for alopecia areata and CTP-692 for schizophrenia,” stated Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals.

“We have had a consistent pipeline strategy to develop innovative medicines based on well-established biology, which is the foundation for CTP-543, a JAK inhibitor for alopecia areata, and for CTP-692, a deuterated D-serine which is an NMDA co-agonist. Concert’s financial resources are dedicated to these proprietary candidates, and our clinical programs are focused on demonstrated efficacy and safety for unmet needs in these chronic diseases affecting millions of patients.”

Dr. Tung continued, “For our partnered programs, including AVP-786, the clinical rationale and all development costs are the responsibilities of our collaborators.” On September 27, 2019, Concert’s collaborator, Avanir Pharmaceuticals, Inc., announced that the second study of its Phase 3 clinical program for AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s disease did not meet its primary and key secondary endpoints.

At the Cantor Healthcare Conference, Dr. Tung will highlight recent developments and upcoming milestones for Concert’s two wholly-owned clinical candidates during the presentation.

CTP-543: an investigational treatment for moderate-to-severe alopecia areata

In September 2019, Concert reported positive topline results from a recently completed Phase 2 dose-ranging trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata. CTP-543 achieved its primary endpoint in the 8 mg and 12 mg twice-daily dosing cohorts. Treatment with 8 and 12 mg twice-daily of CTP-543 for 24 weeks was generally well tolerated and resulted in significant hair regrowth and significant ratings of improvement in individuals with alopecia areata.

Concert plans to present the Phase 2 dose-ranging results in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Annual Congress on October 12, 2019 in Madrid, Spain.

Concert also initiated two open-label studies in 2019 evaluating once-daily vs. twice-daily dosing. Both studies are fully enrolled. Topline data from the first study is expected by year-end 2019 and the results from the second study are expected in the first half of 2020.

The CTP-543 development program is based on well-established biology that Janus kinase (JAK) signaling underlies the pathophysiology in alopecia areata.
The Company intends to advance CTP-543 into Phase 3 in 2020.

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 Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

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Concert Pharma’s CTP-543 trial for alopecia areata

Patient enrolment completed in Concert Pharma’s CTP-543 trial for alopecia areata

Concert Pharmaceuticals, Inc. (CNCE) today announced that it has completed patient enrolment of an open label clinical trial to evaluate once-daily 24 mg compared to twice-daily 12 mg oral dosing of CTP-543 in patients with alopecia areata. Topline data from this dose regimen trial is expected in the first half of 2020.

“We are extremely grateful to the patients who volunteer to participate in our clinical trials and support our mission to develop a new treatment for alopecia areata. These patients, along with the investigators and their teams who work together with us, are essential in the development of new treatment options alopecia areata,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals.

The open label trial (NCT03941548) is a randomized, multi-center study in the United States and Canada to evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543 in 66 adult patients with moderate-to-severe alopecia areata.

Patients in the trial were randomized to receive either 12 mg twice-daily or 24 mg once-daily of CTP-543 over a 24-week treatment period. The primary outcome measure is the relative change in Severity of Alopecia Tool (SALT) score at Week 24 from baseline. All patients who complete 24 weeks of treatment are eligible to enroll into a long term open label extension study of CTP-543.

Previously, the Company announced it has fully enrolled the first open label dose regimen trial evaluating 8 mg twice-daily compared to 16 mg once-daily of CTP-543 in patients with alopecia areata, with topline data from this trial expected in the fourth quarter of 2019.

Available data from the dose regimen trials along with Concert’s recently completed Phase 2 study of CTP-543 are intended to support an end of Phase 2 discussion with the U.S. Food and Drug Administration (FDA) in the first quarter of 2020.

Additional information about CTP-543 clinical trials are available on www.clinicaltrials.gov.

About CTP-543 Phase 2 Results

In September 2019, the Company reported topline results from its CTP-543 dose-ranging Phase 2 trial in patients with moderate-to-severe alopecia areata. At 24 weeks, patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool (SALT).

Both of these active dose groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT at Week 24 from baseline. At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily CTP-543 also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale than did patients who received placebo. Treatment with CTP-543 was generally well tolerated.

The most common (≥10%) side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection, and acne. One serious adverse event of facial cellulitis was reported; however, after a brief dose interruption, treatment was continued and this patient completed the trial. Additional information about the CTP-543 Phase 2 results is available in the Scientific Presentations section of Company’s website.

About CTP-543 and Alopecia Areata

CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2 for the potential treatment of alopecia areata. The FDA has granted Fast Track designation for CTP-543 for the treatment of alopecia areata.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata 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 FDA for the treatment of alopecia areata.

Patient enrolment completed in Concert Pharma’s CTP-543 trial for alopecia areata

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