- Topline results from CIMPASI-1, the second of three Phase 3 trials in psoriasis clinical development program
- Findings confirm CIMZIA results observed in earlier CIMPASI-2 trial
- Results from third and final Phase 3 trial expected 1Q17
BRUSSELS, Belgium and MENLO PARK, CA, USA I December 08, 2016 I UCB (UCB.BR) and Dermira, Inc. (DERM) today announced topline results from CIMPASI-1, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-1 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. This is the second of three Phase 3 clinical trials evaluating CIMZIA in this patient population.1 UCB and Dermira announced topline results from CIMPASI-2 in October 2016.
“The CIMPASI-1 results support our belief that CIMZIA may one day benefit patients currently living with moderate-to-severe plaque psoriasis,” said Luis Peña, chief development officer of Dermira. “Considering the favorable results from the CIMPASI-1 and CIMPASI-2 trials, we are looking forward to the results from CIMPACT, the final and largest Phase 3 trial, which is evaluating CIMZIA compared to both placebo and ENBREL in psoriasis patients. We expect to report the results from CIMPACT in the first quarter of 2017.”
“Based on the Phase 3 trial results to date, CIMZIA, the only Fc-free, PEGylated anti-TNF, has the potential to be a valuable treatment option for women and men living with psoriasis. We are proud of the progress we have made with this clinical trial program and of our partnership with Dermira, which will ultimately help broaden access to CIMZIA for psoriasis patients,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB.
CIMPASI-1 had an identical trial design to CIMPASI-2. The co-primary endpoints evaluated in both trials were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.1
In the CIMPASI-1 trial, consistent with the results of the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.
A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to three dosing arms—400 mg every two weeks (n=88), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=95), or placebo every two weeks (n=51). At week 16, the response rate for patients who achieved a PASI 75 was 75.8% for patients receiving the 400 mg dose every two weeks and 66.5% for patients receiving the 200 mg dose every two weeks, compared to 6.5% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 57.9% for the 400 mg dose-treated patients and 47.0% for the 200 mg dose-treated patients, compared to 4.2% for the patients receiving placebo.
The adverse event profile appears consistent with the adverse event profiles observed with CIMZIA in currently approved indications.1
CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
The data from this trial will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.
About CIMZIA Phase 3 Program
The Phase 3 clinical development program, which is led by Dermira in collaboration with UCB Pharma S.A., is designed to evaluate the efficacy and safety of CIMZIA in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of three trials that have enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. If results from the Phase 3 clinical trial program are positive, regulatory submissions in the United States (U.S.), Canada and European Union (EU) are expected.
Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-center trials designed to evaluate the efficacy and safety of CIMZIA in the treatment of patients with moderate-to-severe chronic plaque psoriasis. CIMPASI-1 and CIMPASI-2 enrolled 234 and 227 patients, respectively. A third study, CIMPACT, enrolled 559 patients and is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center study designed to evaluate the efficacy and safety of CIMZIA in patients with moderate-to-severe chronic plaque psoriasis.
CIMPASI-1 and CIMPASI-2 have co-primary endpoints comprising both PASI 75 and the percentage of patients achieving at least a two-point improvement to a final score representing clear or almost clear skin on a five-point PGA scale, each compared with placebo, at week 16. The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. A secondary objective of the CIMPACT trial is to compare the efficacy of CIMZIA to ENBREL®* (etanercept). Patients in each trial may receive blinded CIMZIA treatment for up to 48 weeks followed by an open-label treatment period of up to an additional 96 weeks.
In October 2016, UCB and Dermira announced topline results from the CIMPASI-2 trial. In this trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to three dosing arms—400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49).
Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the U.S., Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the U.S. and Canada.
CIMZIA® is a registered trademark of the UCB Group of Companies.
*ENBREL® (etanercept) is a registered trademark of Amgen Inc.
About Psoriasis
Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the world’s population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.2
About Cimzia® In the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
References
- UCB Data on File.
- International Federation of Psoriasis Associations. Accessed July 14, 2016 at http://www.worldpsoriasisday.com/web/page.aspx?refid=130
About Dermira
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio includes three late-stage product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3 development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and DRM01, in Phase 2b development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (UCB.BR). Follow us on Twitter: @UCB_news.
SOURCE: UCB
Post Views: 127
- Topline results from CIMPASI-1, the second of three Phase 3 trials in psoriasis clinical development program
- Findings confirm CIMZIA results observed in earlier CIMPASI-2 trial
- Results from third and final Phase 3 trial expected 1Q17
BRUSSELS, Belgium and MENLO PARK, CA, USA I December 08, 2016 I UCB (UCB.BR) and Dermira, Inc. (DERM) today announced topline results from CIMPASI-1, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-1 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. This is the second of three Phase 3 clinical trials evaluating CIMZIA in this patient population.1 UCB and Dermira announced topline results from CIMPASI-2 in October 2016.
“The CIMPASI-1 results support our belief that CIMZIA may one day benefit patients currently living with moderate-to-severe plaque psoriasis,” said Luis Peña, chief development officer of Dermira. “Considering the favorable results from the CIMPASI-1 and CIMPASI-2 trials, we are looking forward to the results from CIMPACT, the final and largest Phase 3 trial, which is evaluating CIMZIA compared to both placebo and ENBREL in psoriasis patients. We expect to report the results from CIMPACT in the first quarter of 2017.”
“Based on the Phase 3 trial results to date, CIMZIA, the only Fc-free, PEGylated anti-TNF, has the potential to be a valuable treatment option for women and men living with psoriasis. We are proud of the progress we have made with this clinical trial program and of our partnership with Dermira, which will ultimately help broaden access to CIMZIA for psoriasis patients,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB.
CIMPASI-1 had an identical trial design to CIMPASI-2. The co-primary endpoints evaluated in both trials were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.1
In the CIMPASI-1 trial, consistent with the results of the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.
A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to three dosing arms—400 mg every two weeks (n=88), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=95), or placebo every two weeks (n=51). At week 16, the response rate for patients who achieved a PASI 75 was 75.8% for patients receiving the 400 mg dose every two weeks and 66.5% for patients receiving the 200 mg dose every two weeks, compared to 6.5% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 57.9% for the 400 mg dose-treated patients and 47.0% for the 200 mg dose-treated patients, compared to 4.2% for the patients receiving placebo.
The adverse event profile appears consistent with the adverse event profiles observed with CIMZIA in currently approved indications.1
CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
The data from this trial will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.
About CIMZIA Phase 3 Program
The Phase 3 clinical development program, which is led by Dermira in collaboration with UCB Pharma S.A., is designed to evaluate the efficacy and safety of CIMZIA in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of three trials that have enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. If results from the Phase 3 clinical trial program are positive, regulatory submissions in the United States (U.S.), Canada and European Union (EU) are expected.
Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-center trials designed to evaluate the efficacy and safety of CIMZIA in the treatment of patients with moderate-to-severe chronic plaque psoriasis. CIMPASI-1 and CIMPASI-2 enrolled 234 and 227 patients, respectively. A third study, CIMPACT, enrolled 559 patients and is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center study designed to evaluate the efficacy and safety of CIMZIA in patients with moderate-to-severe chronic plaque psoriasis.
CIMPASI-1 and CIMPASI-2 have co-primary endpoints comprising both PASI 75 and the percentage of patients achieving at least a two-point improvement to a final score representing clear or almost clear skin on a five-point PGA scale, each compared with placebo, at week 16. The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. A secondary objective of the CIMPACT trial is to compare the efficacy of CIMZIA to ENBREL®* (etanercept). Patients in each trial may receive blinded CIMZIA treatment for up to 48 weeks followed by an open-label treatment period of up to an additional 96 weeks.
In October 2016, UCB and Dermira announced topline results from the CIMPASI-2 trial. In this trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to three dosing arms—400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49).
Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the U.S., Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the U.S. and Canada.
CIMZIA® is a registered trademark of the UCB Group of Companies.
*ENBREL® (etanercept) is a registered trademark of Amgen Inc.
About Psoriasis
Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the world’s population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.2
About Cimzia® In the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
References
- UCB Data on File.
- International Federation of Psoriasis Associations. Accessed July 14, 2016 at http://www.worldpsoriasisday.com/web/page.aspx?refid=130
About Dermira
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio includes three late-stage product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3 development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and DRM01, in Phase 2b development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (UCB.BR). Follow us on Twitter: @UCB_news.
SOURCE: UCB
Post Views: 127
