SAN DIEGO, Feb. 17, 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 presented new findings from its glycopyrronium tosylate (formerly DRM04) Phase 3 clinical program. The data showed that when applied topically, the investigational therapy improved disease severity, reduced sweat production and was associated with improved quality of life outcomes for pediatric patients (ages 9 to 16) with primary axillary hyperhidrosis (excessive underarm sweating), compared to vehicle-treated patients.
These findings are consistent with results previously reported in adult patients (ages 17 and older). The data were featured in an oral presentation during the Late-Breaking Research Forums at the 76th Annual Meeting of the American Academy of Dermatology (AAD) in San Diego.
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.
“Primary axillary hyperhidrosis has long been associated with social stigma, isolation and embarrassment,” said Adelaide Hebert, M.D., Chief of Pediatric Dermatology at McGovern Medical School at UTHealth, Houston and Children’s Memorial Hermann Hospital, and a lead investigator for the Phase 3 clinical program. “We know that young people with axillary hyperhidrosis are experiencing these effects at a critical time in their physical and social development. If left unaddressed, these effects could lead to profound emotional and social distress that has a negative impact on overall quality of life.1”
Phase 3 ATMOS-1 and ATMOS-2 Pediatric Post-Hoc Analysis
- ATMOS-1 and ATMOS-2 were designed as multi-center, randomized, double-blind, vehicle-controlled, four-week Phase 3 trials assessing the efficacy and safety of glycopyrronium tosylate in patients ages 9 years of age and older. Patients had primary axillary hyperhidrosis for six months or more, produced at least 50 mg of sweat in each underarm over a five-minute period and rated the severity of their sweating as a four or higher on an 11-point numerical rating scale (Axillary Sweating Daily Diary (ASDD)/Children’s ASDD [ASDD-C]; Item 2), and had a three or a four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). All patients were evaluated after four weeks of treatment with glycopyrronium tosylate or vehicle.
- Overall, 463 patients were randomized to glycopyrronium tosylate and 234 to vehicle. Of these, 44 were pediatric patients, ages 9 to 16 years of age (glycopyrronium tosylate, n=25; vehicle, n=19). Baseline disease characteristics were similar between age groups.
- Efficacy results were consistent among pediatric and adult patients. Specifically, pooled ASDD/ASDD-C severity scale responder rates for pediatric vs. adult patients were 59.9% vs. 60.2% for glycopyrronium tosylate-treated and 13.0% vs. 28.8% for vehicle-treated patients, respectively.
- The median absolute changes in sweat production at week four for pediatric vs. adult patients were -64.2 mg vs. -80.6 mg for glycopyrronium tosylate-treated and -53.7 mg vs. -62.0 mg for vehicle-treated patients, respectively.
- The proportions of patients experiencing a reduction of at least 50 percent in sweat production at week four for pediatric vs. adult patients were 79.9% vs. 74.3% of glycopyrronium tosylate-treated and 54.8% vs. 53.0% of vehicle-treated patients, respectively.
- The mean decrease from baseline in the Children’s Dermatology Quality of Life Index was -8.1 for glycopyrronium tosylate-treated vs. -1.9 for vehicle-treated patients. This is consistent with that observed for the Dermatology Life Quality Index measure observed for adults, -8.4 for glycopyrronium tosylate-treated vs. -4.7 for vehicle-treated patients.
- The rates of treatment emergent adverse events* reported for pediatric vs. adult patients were 44.0% vs. 56.7% of glycopyrronium tosylate-treated and 10.5% vs. 34.3% of vehicle-treated patients, respectively. Most were related to anticholinergic activity and were mild, transient and infrequently led to drug discontinuation.
“We are encouraged by the new pediatric data analyses from the Phase 3 clinical trials which reported the safety and efficacy of glycopyrronium tosylate in patients as young as nine years old,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “Importantly, glycopyrronium tosylate also demonstrated its potential to reduce the daily burden of the condition for individuals at a critical stage in their emotional and social development. These results add to growing body of evidence which suggests that glycopyrronium tosylate could one day be an important new treatment option for millions of axillary hyperhidrosis suffers seeking treatments to more effectively manage this condition.”
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.2 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, social and physical impairment.3,4 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.5
About Glycopyrronium Tosylate and the Phase 3 Studies
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.
In November 2017, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for glycopyrronium tosylate based on results from ATMOS-1 and ATMOS-2, Phase 3 clinical trials designed to assess the safety and efficacy of glycopyrronium tosylate compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis. In addition to these two trials, an open-label trial, ARIDO, assessed the long-term safety of glycopyrronium tosylate. The Prescription Drug User Fee Act target date for the completion of the FDA’s review of the NDA is June 30, 2018.
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; glycopyrronium tosylate potentially becoming an important new treatment option for millions of axillary hyperhidrosis suffers seeking treatments to more effectively manage the condition; and the target date for completion of the FDA’s review of the NDA for glycopyrronium tosylate. 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.
*Treatment emergent adverse events are defined as any safety related side effect not present prior to the start of a treatment or any event that already exists in a person that worsens in either intensity or frequency following exposure to the treatment.
- Bohaty et. Al., Special Considerations for Children with Hyperhidrosis. Dermatologic Clinics 32 (4): 477-484, 2014.
- 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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