MENLO PARK, Calif., Feb. 12, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), 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, today announced that new findings from its Phase 3 glycopyrronium tosylate (formerly DRM04) clinical program will be highlighted at the 76th Annual Meeting of the American Academy of Dermatology (AAD), taking place in San Diego, February 16-20.
Of note, new data from the ATMOS-1 and ATMOS-2 Phase 3 trials highlighting the safety and efficacy of glycopyrronium tosylate in pediatric patients (ages 9-16) will be featured in an oral presentation during the meeting’s late-breaking news session. In addition, data from two post-hoc analyses from the Phase 3 pivotal trials will be presented in poster presentations during the meeting. Dermira will also sponsor an expert panel intended to educate dermatologists about hyperhidrosis, its impact on people living with the condition and current and future treatment approaches.
Primary axillary hyperhidrosis is a medical condition that results in sweating beyond what is needed for normal body temperature regulation. Glycopyrronium tosylate is an investigational agent formulated as a topical, once-daily anticholinergic wipe, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
“We know primary axillary hyperhidrosis affects nearly 10 million people in the United States1 and its negative impact on people can be incredibly profound,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “We are pleased to share additional data from the glycopyrronium tosylate clinical program and provide dermatology practitioners with an opportunity to learn about the effect this condition can have on the lives of people when it is not recognized, acknowledged and treated.”
Abstracts of Interest:
Title: Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Prior Treatment Analyses from the ATMOS-1 and ATMOS-2 Phase 3 Randomized Clinical Trials
Date and Time: Saturday, February 17, 2018 from 3:30 – 5:30 PM PT
Location: San Diego Convention Center, Room 5B at the Late-Breaking Research Forum (Clinical Studies/Pediatric)
Abstract Number: 6659
Title: Topical Glycopyrronium Tosylate (DRM04) for the Treatment of Primary Axillary Hyperhidrosis: Pooled Results from the ATMOS-1 and ATMOS-2 Phase 3 Randomized Controlled Trials
Date and Time: Saturday, February 17, 2018 at 9:30 – 9:35 AM PT
Location: San Diego Convention Center, ePoster; Presentation Center 2
Abstract Number: 7583
Title: Open-Label Study Evaluating Long-Term Safety of Topical Glycopyrronium Tosylate (GT) in Patients with Primary Axillary Hyperhidrosis (ARIDO)
Date and Time: Duration of the meeting
Location: San Diego Convention Center, e-Poster viewing area
Abstract Number: 7511
Title: Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Prior Treatment Analyses from the ATMOS-1 and ATMOS-2 Phase 3 Randomized Controlled Trials
Date and Time: Duration of the meeting
Location: San Diego Convention Center, ePoster viewing area
Abstract Number: 7680
Hyperhidrosis is a condition of sweating beyond what is physiologically required for normal thermal regulation and affects an estimated 4.8% of the U.S. population, or approximately 15 million people.1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary hyperhidrosis). Studies have further demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment.2,3 New research indicates that one third of survey respondents indicated their primary axillary hyperhidrosis began before the age of 12, suggesting that axillary hyperhidrosis may affect patients younger than previously identified.4
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 three 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 (underarm sweating beyond what is needed for normal body temperature regulation); olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris; 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 Dermira 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.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. 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; and glycopyrronium tosylate potentially becoming a treatment option for people living with hyperhidrosis. 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; the outcome of future discussions with regulatory authorities; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; 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.
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Bahar et. al., The prevalence of anxiety and depression in patients with or without hyperhidrosis (HH). J Am Acad Dermatol. 75(6): 1126-1133, 2016.
- Augustin et. al., Prevalence and disease burden of hyperhidrosis in the adult population. Dermatology. 227: 10-13, 2013.
- Glaser et. al., Prevalence of Multifocal Primary Hyperhidrosis and Symptom Severity Over Time: Results of a Targeted Survey. Dermatologic Surgery. 42(12), 1347–1353, 2016.
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