Breaking News
April 26, 2018 - FDA Alert: Lamictal (lamotrigine): Drug Safety Communication
April 26, 2018 - Massive single-cell survey of kidney cell types reveals new paths to disease
April 26, 2018 - Cognitive behavioral therapy can help children with autism manage emotional challenges
April 26, 2018 - CU Anschutz Medical Campus receives NIH grant to speed up discovery of new treatments
April 26, 2018 - Researchers discover significant distortions in leading genetics study method
April 26, 2018 - New combination therapy could improve survival in children with high-risk neuroblastoma
April 26, 2018 - Scientists clarify casual role of oxidative stress in metabolically abnormal and healthy obesities
April 26, 2018 - Home-based exercise program found ineffective for patients with peripheral artery disease
April 26, 2018 - Choroidal Thickness Changes in Patients With Untreated DM
April 26, 2018 - Medical chemists discover peptic ulcer treatment metallodrug effective in ‘taming’ superbugs
April 26, 2018 - UB researchers build 3D-printed, drug-filled dentures to fight against infections
April 26, 2018 - Researchers find role of iron storage gene in slowing down prostate cancer growth
April 26, 2018 - Study suggests link between regular mid-day naps and neurocognitive function in teens
April 26, 2018 - Researchers gain ground-breaking insights into how inflammatory diseases work
April 26, 2018 - Injured U.S. Vet Receives World’s First Penis/Scrotum Transplant
April 26, 2018 - Researchers find existing drug effective at preventing onset of type 1 diabetes
April 26, 2018 - MGH researchers identify risk factors for drug overdose in youth with substance use disorders
April 26, 2018 - Researchers develop new vaccine to help people overcome bath salts abuse
April 26, 2018 - Genetic signature predicts diabetes diagnosis
April 26, 2018 - Study shows link between restless legs syndrome symptoms and brain structure
April 26, 2018 - MU researchers use new techniques to fight against diabetic retinopathy
April 26, 2018 - AAE’s new practice statements aim at improving patient care
April 26, 2018 - Expression of long non-coding RNAs can result in high levels of specific proteins involved in cancer
April 26, 2018 - FDA re-examining safety of new drug approved for Parkinson’s disease psychosis
April 26, 2018 - Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
April 26, 2018 - Bacteria boost antifungal drug resistance in severe childhood tooth decay
April 26, 2018 - New study affirms bedtime habits of Americans
April 26, 2018 - Hospital patients are more interested in tracking their health data, research shows
April 26, 2018 - Study shows gene variations associated with malaria risk
April 26, 2018 - Inhealthcare teams up with MSKassist to combat problems related to obesity and aging
April 26, 2018 - Caffeine during pregnancy – babies 66 percent more likely to become overweight
April 26, 2018 - FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
April 26, 2018 - Pricey dental implants often best but insurance rarely pays
April 26, 2018 - Advion’s Peak Express software now available with the expression compact mass spectrometer
April 25, 2018 - Researchers find link between pneumonia in older people and PPI prescriptions
April 25, 2018 - Alcohol damages microbiome in the mouth
April 25, 2018 - Regular soaking in hot tub improves health outlook in obese women with PCOS
April 25, 2018 - FDA Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers
April 25, 2018 - Sunshine could hold clues on the timing for a severe form of heart attack, study says
April 25, 2018 - Sartorius Stedim Biotech launches mini bioreactor vessel for ambr 250 high throughput system
April 25, 2018 - Biofeedback-assisted relaxation may help children during medical procedures
April 25, 2018 - Key signaling protein in Huntington’s disease found to have deleterious effects on heart function, shows study
April 25, 2018 - Celecoxib Lowers Opioid Use Post Head & Neck Cancer Surgery
April 25, 2018 - New ‘brain health index’ can predict how well patients will do after stroke
April 25, 2018 - Positive interventions in sepsis management raise key questions about E. coli reduction targets
April 25, 2018 - Scientists identify new DNA structure within living human cells
April 25, 2018 - E. coli’s toxin-antitoxin system inhibits bacterial growth
April 25, 2018 - Researchers uncover reason why exercise may be beneficial for the heart
April 25, 2018 - Researcher presents case study of asymptomatic patient with severe mitral regurgitation
April 25, 2018 - Use ‘Proper Form’ When Practicing Yoga
April 25, 2018 - Study reports possible novel method for stopping untreatable pediatric brain cancers
April 25, 2018 - Visually guided walking paves way for better treatment for mobility impairments
April 25, 2018 - Researchers identify novel pathway in development of AML with poor prognosis
April 25, 2018 - Cardiovascular disease may only be a matter of time for people with healthy obesity
April 25, 2018 - Girls with type 2 diabetes have high frequency of menstrual irregularities
April 25, 2018 - Study explains why intense exercise curbs appetite
April 25, 2018 - Experimental drug for rheumatoid arthritis prevents side effect of stem cell transplants
April 25, 2018 - Why are Antibiotics Overprescribed for Meningitis Treatment?
April 25, 2018 - Consuming protein supplements with meals, rather than between meals, may promote weight control
April 25, 2018 - Seeing prostate cancer in a new light
April 25, 2018 - Jacobs Medical Center recognized with Baby Friendly Designation for efforts in mother-baby bonding
April 25, 2018 - Gene related to high fatality could be used as biomarker in patients with P. aeruginosa infection
April 25, 2018 - Study shows patients in major prostate cancer study are more likely to die than real-world patients
April 25, 2018 - HBP researchers develop new tool to examine role of genes in disease-relevant brain regions
April 25, 2018 - Trio’s pioneering silicone ostomy product wins prestigious Queen’s Award for Enterprise
April 25, 2018 - Study highlights potential of stem cells derived from adults in regenerative medicine
April 25, 2018 - A new, emerging procedure burns cancer cells
April 25, 2018 - Acclarent introduces real-time, 3D navigation system for ENT procedures
April 25, 2018 - Italy’s prestigious Veneto Institute of Oncology acquires MILabs’ latest VECTor5CT system
April 25, 2018 - Future screening is more likely for people with false-positive cancer screening results
April 25, 2018 - Tweezers made of laser beams manipulate atoms to make new molecules
April 25, 2018 - Elevated immune function during childhood linked to stunted growth
April 25, 2018 - FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
April 25, 2018 - Research reveals autism and schizophrenia share common traits
April 25, 2018 - Perceived stress decreases for most women over 15-year span, study finds
April 25, 2018 - Coastal Genomics’ LightBench integrated with Hamilton liquid handler systems to bring efficiencies, savings for clinical laboratories
April 25, 2018 - Researchers discover new gene associated with aortic aneurysms
April 25, 2018 - Preantral zinc deficiency may affect fertility months
April 25, 2018 - Repurposing existing antiviral drugs for multiple infections
April 25, 2018 - Can GAC Be Used to Control Priority Unregulated DBPs in Drinking Water?
Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints

Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints

image_pdfDownload PDFimage_print

MENLO PARK, Calif., March 05, 2018 (GLOBE NEWSWIRE) — Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to delivering new therapies to patients living with chronic skin conditions, today announced that the investigational treatment olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate-to-severe acne vulgaris.

“We are surprised and extremely disappointed by the results of the Phase 3 program,” said Tom Wiggans, chairman and chief executive officer of Dermira. “This is disappointing not only for the company, but also for patients who are living with this condition and dermatologists who have been looking for novel therapies to treat them.”

“We are continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program. However, based on the information we have to date, we expect to discontinue the development program,” said Luis Peña, chief development officer of Dermira. “We want to thank our employees, investigators and partners for their commitments to the acne development program and, most importantly, the patients who participated in these trials.”

The co-primary endpoints of CLAREOS-1 and CLAREOS-2 were the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-grade improvement from baseline to a final grade of zero or one on the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured on the face at the end of the 12-week treatment period. Safety and tolerability were also evaluated.

Phase 3 Results

  • The reductions in the numbers of inflammatory lesions from baseline to week 12 in patients treated with olumacostat glasaretil in CLAREOS-1 and CLAREOS-2 were 14.3 and 16.6, respectively, compared to 13.7 and 15.3, respectively, in patients in the corresponding vehicle groups.
  • The reductions in the numbers of non-inflammatory lesions from baseline to week 12 in patients treated with olumacostat glasaretil in CLAREOS-1 and CLAREOS-2 were 14.8 and 17.8, respectively, compared to 11.2 and 17.4, respectively, in patients in the corresponding vehicle groups.
  • In CLAREOS-1 and CLAREOS-2, the percentages of patients treated with olumacostat glasaretil who achieved a two-grade improvement from baseline to a final grade of zero or one on the IGA scale at week 12 were 19.1% and 16.3%, respectively, compared to 20.8% and 11.8%, respectively, of patients in the corresponding vehicle groups.
  • None of these co-primary endpoint results were statistically significant.

Consistent with the Phase 2a and 2b studies, olumacostat glasaretil was well-tolerated. Adverse events were primarily mild or moderate in severity. No treatment-related serious adverse events were reported, and no new or unexpected events were observed.

“We remain dedicated to bringing new treatments to people living with chronic, underserved skin conditions. As we look ahead, we are focused on building a commercial organization to support the anticipated launch of glycopyrronium tosylate for axillary hyperhidrosis later this year, subject to FDA approval, as well as our Phase 2b trial evaluating lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis, for which we expect to announce topline data in the first half of 2019,” added Wiggans.

About Olumacostat Glasaretil Phase 3 Program

The Phase 3 clinical program included two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, designed to assess the efficacy and safety of olumacostat glasaretil compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA). The program enrolled a total of 1,503 patients (CLAREOS-1, n=759 and CLAREOS-2, n=744) ages nine years and older with moderate-to-severe acne vulgaris at 94 sites in the United States, Canada and Australia. In each trial, patients were randomized in a 2:1 fashion to receive either olumacostat glasaretil at a concentration of 5% or vehicle twice daily for 12 weeks.

The Phase 3 program also included an open-label study, CLARITUDE, assessing the long-term safety of olumacostat glasaretil, in which patients from either of the two Phase 3 studies were permitted to continue to receive treatment for up to an additional 36 weeks.

About Dermira

Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s pipeline includes two late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), for which a New Drug Application is under review by the U.S. Food and Drug Administration for the treatment of primary axillary hyperhidrosis (excessive underarm sweating beyond what is needed for normal body temperature regulation), and lebrikizumab, in Phase 2b development for the treatment of moderate-to-severe atopic dermatitis. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow @DermiraInc on Twitter and LinkedIn.

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), LinkedIn page (https://www.linkedin.com/company/dermira-inc) and corporate Twitter account (@DermiraInc) 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, LinkedIn page and Twitter account in addition to following its SEC filings, press releases, public conference calls and webcasts.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: Dermira’s goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; Dermira’s expectation to discontinue the olumacostat glasaretil development program; Dermira’s ability to bring new treatments to people living with chronic, underserved skin conditions; Dermira’s plans to build a commercial organization; potential regulatory approval and commercial launch, and anticipated timing of such approval and launch, of glycopyrronium tosylate for axillary hyperhidrosis; and expectations regarding the timing of topline data for Dermira’s Phase 2b dose-ranging study of lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; competition and market acceptance of Dermira’s product candidates, if approved; Dermira’s ability to execute on its business plans and commercialization goals; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Source: Dermira, Inc.

Posted: March 2018

Tagged with:

About author

Related Articles