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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 Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata

Concert Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata

Concert Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata during Late-Breaker Session at American Academy of Dermatology Annual Meeting

Interim Data Analysis from 8 mg Twice-Daily Cohort of Investigational CTP-543 Showed Statistically Significant Effect on Primary Endpoint in Patients with Moderate-to-Severe Alopecia Areata

Concert Pharmaceuticals, Inc. today announced that interim results from its Phase 2 clinical trial evaluating its product candidate CTP-543 in patients with moderate-to-severe alopecia areata will be presented in an oral presentation during the late-breaking clinical trials session at the American Academy of Dermatology (AAD) Annual Meeting on March 2, 2019, in Washington, DC.

The interim results from this dose-ranging trial showed that treatment with CTP-543 administered at an 8 mg twice-daily dose for 24 weeks met the primary endpoint with a statistically significant greater hair regrowth responder rate compared to placebo. The primary endpoint measures the proportion of patients who are responders to treatment, defined as a ≥ 50% relative reduction in their overall Severity of Alopecia Tool (SALT) score from baseline.

“Alopecia areata is a chronic autoimmune disease resulting in patchy or complete hair loss that can have a profound effect on patients’ health and well-being and can impact their daily lives. I am happy to see new investigational medicines emerging with promising clinical data, including Janus kinase (JAK) inhibitors such as CTP-543,” said Dr. Brett King, Associate Professor of Dermatology at Yale School of Medicine. “The data for CTP-543 shows that JAK inhibitors have the potential to be an effective treatment option for patients with this challenging disease.”

Patients with moderate-to-severe alopecia areata enrolled in the first two cohorts received 4 mg or 8 mg of CTP-543 twice-daily or placebo twice-daily for 24 weeks. The final cohort evaluating 12 mg of CTP-543 or placebo twice-daily is ongoing. The trial randomized 104 patients in the 4 mg and 8 mg cohorts.

The oral presentation will highlight the interim results for the 8 mg twice-daily dosing cohort of CTP-543, which achieved the Phase 2 trial’s primary endpoint, in patients with moderate-to-severe alopecia areata after 24 weeks of dosing. 47% of patients treated with 8 mg of CTP-543 twice-daily achieved a ≥ 50% relative reduction in their overall SALT, score from baseline, which was a significant improvement compared to 8.6% for placebo (p < 0.001).

The responders in the 8 mg twice-daily dose group were evenly distributed among patients with patchy alopecia areata and the more severe forms, alopecia totalis and alopecia universalis. The percentage of patients achieving the primary endpoint continued to increase up to Week 24, and regrowth of hair did not appear to plateau at Week 24. For the 4 mg cohort, 21% of patients achieved a ≥ 50% relative reduction in their overall SALT score from baseline, however these differences were not significantly different from placebo.

The most common side effects in the interim analysis were headache, upper respiratory tract infection, cough, acne and nausea. No serious adverse events were reported.

“We are very pleased that we were selected to present our initial safety and efficacy data with CTP-543 in patients with moderate to severe alopecia areata to the members of the Academy. We believe the results are highly encouraging and we are excited to share these data with the broader treatment community at the annual meeting,” stated James V. Cassella, Ph.D., Concert’s Chief Development Officer, who will make the oral presentation at AAD. “We look forward to advancing the development of CTP-543, as we continue our efforts to bring a new treatment to patients with this medical disease that currently has no approved medications.”

Details from the oral presentation, entitled “JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2a Trial in Alopecia Areata,” will be posted in the Scientific Presentations section of Concert’s website at the start of the oral presentation at the AAD on Saturday, March 2, 2019 at 1:20 p.m. ET.

The Phase 2 trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata.

The primary outcome measure will utilize the Severity of Alopecia Tool (SALT) after 24 weeks of dosing. Patients were sequentially randomized to receive one of three doses of CTP-543 (4 mg, 8 mg, or 12 mg) or placebo twice-daily.

The final cohort evaluating a 12 mg twice-daily dose of CTP-543 compared to placebo is fully enrolled and topline data for the overall study, including the 12mg cohort, is expected in the third quarter of 2019. Additional information about the trial (NCT03137381) is available on www.clinicaltrials.gov.

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.

1 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.

Concert Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata

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Phase 2a Trial of CTP-543 in Alopecia Areata

Concert Pharmaceuticals Completes Enrollment in Phase 2a Trial of CTP-543 in Alopecia Areata

Concert Pharmaceuticals announce that it has completed patient enrollment of its Phase 2a trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata.

The Company expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in the fourth quarter of 2018. Additionally, a Phase 2b clinical trial is expected to begin in 2019.

“The speed with which we enrolled the trial speaks to the significant unmet need for alopecia areata and interest in this program. We are grateful to the patients who volunteered to participate in our trial,” stated James Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals.

The Phase 2a trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata.

Approximately 90 patients were randomized to receive one of two doses of CTP-543 (4 mg or 8 mg twice daily) or placebo.

The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. If appropriate, the protocol may be amended to explore 12 mg twice daily of CTP-543. Additional information about the trial is available on www.clinicaltrials.gov.

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.

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.

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 time.

Phase 2a trial evaluating CTP-543

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.

The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017.

The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the U.S. Food and Drug Administration’s (FDA) 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 address unmet patient needs. The Company’s approach starts with starts with previously studied compounds, including 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 autoimmune and inflammatory 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.

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