• CIMPACT results confirm data from two previously reported Phase 3 CIMZIA trials
  • Submission of marketing applications to regulatory authorities expected in third quarter of 2017

BRUSSELS, Belgium and MENLO PARK, CA, USA I January 19, 2017 I UCB (Euronext: UCB) and Dermira, Inc. (NASDAQ: DERM) today announced key results from CIMPACT, a Phase 3, multi-center, placebo-controlled and active-controlled clinical trial evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPACT trial, CIMZIA demonstrated statistically significant improvements for the primary endpoint. CIMPACT is the third and final Phase 3 clinical trial evaluating CIMZIA in this patient population.  Based on the results of the CIMPACT trial, and those from the previously reported CIMPASI-1 and CIMPASI-2 trials, UCB intends to submit marketing applications to regulatory authorities in the third quarter of 2017. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

The primary endpoint in CIMPACT assessed the percentage of patients on CIMZIA who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo, at week 12. Several secondary endpoints were assessed, including comparisons of the efficacy of CIMZIA to ENBREL® based on PASI 75 response rates at week 12 and comparisons of the response rates of CIMZIA-treated patients to placebo-treated patients at week 16 using (1) PASI 75 and (2) 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. In both the CIMPASI-1 and CIMPASI-2 trials, PASI 75 and PGA were co-primary endpoints assessed at week 16.

“We are pleased that the CIMPACT results are consistent with the efficacy and safety findings observed in two earlier trials evaluating CIMZIA in patients with moderate-to-severe plaque psoriasis,” said Tom Wiggans, chief executive officer of Dermira. “Both companies look forward to submitting these data to regulatory authorities to support a potential approval of CIMZIA as a treatment option for moderate-to-severe chronic plaque psoriasis.”

“The results from CIMPACT support our belief that CIMZIA may one day be an important treatment option for patients living with psoriasis. Our psoriasis clinical development program, and our collaboration with Dermira, aims to provide value to this important patient population and broaden access to CIMZIA, the only Fc-free, PEGylated anti-TNF,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. “We look forward to sharing additional data from all three trials at an upcoming medical congress.”

In all three CIMZIA Phase 3 clinical trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses.

CIMPACT Results

  • A total of 559 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPACT trial to one of four dosing arms—CIMZIA at 400 mg every two weeks (n=167), CIMZIA at 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=165), ENBREL at 50 mg twice weekly (n=170), or placebo every two weeks (n=57).
  • CIMZIA demonstrated statistically significant improvements in the primary endpoint. At week 12, the response rate for patients who achieved a PASI 75 was 66.7% for patients receiving the CIMZIA 400 mg dose every two weeks and 61.3.% for patients receiving the CIMZIA 200 mg dose every two weeks, compared to 5.0% for patients receiving placebo.
  • The CIMPACT trial also assessed a number of secondary endpoints, including:
    • At week 16, the response rate for patients who achieved a PASI 75 was 74.7% for patients receiving the 400 mg dose every two weeks and 68.2% for patients receiving the 200 mg dose every two weeks, compared to 3.8% 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 58.4% for the 400 mg dose-treated patients and 48.3% for the 200 mg dose-treated patients, compared to 3.4% for the patients receiving placebo.
    • At week 16, both CIMZIA dosing arms were statistically significant compared to placebo for the PASI 75 and PGA secondary endpoints.
    • At week 12, CIMZIA achieved superiority at the 400 mg dose and non-inferiority at the 200 mg dose compared to ENBREL.

CIMPASI-1 Results

  • A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to one of 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.

CIMPASI-2 Results

  • A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to one of 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).
  • At week 16, the response rate for patients who achieved a PASI 75 was 82.6% for patients receiving the 400 mg dose every two weeks and 81.4% for patients receiving the 200 mg dose every two weeks, compared to 11.6% 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 71.6% for the 400 mg dose-treated patients and 66.8% for the 200 mg dose-treated patients, compared to 2.0% for the patients receiving placebo.

The adverse event profile across all three trials appears consistent with the adverse event profiles observed with CIMZIA in currently approved indications.1

The data from these trials will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.

As previously communicated, positive results from all three clinical trials are needed to support regulatory submissions in the United States (U.S.), Canada and European Union (EU). Based on the results from CIMPASI-1, CIMPASI-2 and CIMPACT, UCB plans to submit the data to regulatory authorities in the third quarter of 2017 to support potential approvals for CIMIZIA as a treatment option for patients with moderate-to-severe chronic plaque psoriasis. 

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.

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 had 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, was the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. Secondary endpoints of the CIMPACT trial included (1) a comparison of the efficacy of CIMZIA to ENBREL as measured by PASI 75 response at week 12 and (2) the percentage of patients who achieved at least a two-point improvement to a final score representing clear or almost clear skin on the five-point PGA scale, at week 12. 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.

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.

About Cimzia® in the EU/EEA
In the EU, Cimzia® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

  • Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
  • Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4

References

  1. UCB Data on File.
  2. 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 Phase 3 product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil, in 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 (symbol: UCB). Follow us on Twitter: @UCB_news.

SOURCE: UCB