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(September 13, 2017)
- People suffering from primary axillary hyperhidrosis (excessive underarm sweating beyond what is needed to maintain normal body temperature) report that the condition has a significant impact on their daily lives, often resulting in avoidance of social interactions and taking additional measures to manage their excessive sweating
- Patients treated with glycopyrronium tosylate in Phase 3 clinical trials reported greater improvements across several measures designed to evaluate the impact of the investigational treatment on excessive underarm sweating
MENLO PARK, Calif., Sept. 13, 2017 (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 patient-reported outcomes data from two Phase 3 clinical trials evaluating topical, once-daily treatment with glycopyrronium tosylate (formerly DRM04) for patients with primary axillary hyperhidrosis (excessive underarm sweating), a medical condition that results in sweating beyond what is needed for normal body temperature regulation. Glycopyrronium tosylate is formulated as a once-daily anticholinergic agent, administered as a topical wipe, and is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
At the start of the clinical trials, patients reported that their excessive sweating was highly burdensome, with many reporting that the condition resulted in them avoiding social interactions and taking additional measures to cope with the condition, such as changing their shirt and showering multiple times during the day. After four weeks of treatment with glycopyrronium tosylate, patients in both trials reported improvements in their sweating severity, rating their sweating as much better or moderately better compared to treatment with vehicle. In addition, patients treated with glycopyrronium tosylate topical wipes reported greater weekly average improvements on all items that measured the daily burden of disease associated with axillary hyperhidrosis. Collectively, these data suggest that if approved, glycopyrronium tosylate wipes would have the potential to reduce the burden of disease for patients with excessive underarm sweating.
“People suffering from hyperhidrosis cope not only with the symptoms of the condition, but with the intense stigma that comes with excessive, uncontrollable sweating, which can have a profound impact on their lives,” said Lisa J. Pieretti, Executive Director and a founding member of the International Hyperhidrosis Society, an international non-profit organization dedicated to improving the quality of life among those affected by excessive sweating through advocacy, education, research and awareness for all sufferers and those who provide care. “This common condition is finally benefitting from the scientific innovation that has led to important breakthroughs in other dermatological conditions. We hope that increased awareness will lead to accurate diagnosis, access to additional treatment options, and an improvement in the quality of life for these sufferers.”
“Primary axillary hyperhidrosis has long been associated with a poor quality of life for patients, resulting in changes in social and physical behaviors and feelings of embarrassment,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “We are encouraged by these new patient-reported outcomes data from the Phase 3 trials, which combined with the safety and efficacy results, provide additional support that treatment with glycopyrronium tosylate has the potential to reduce the daily burden of a condition affecting millions of Americans.”
The two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, were designed to evaluate the safety and efficacy of glycopyrronium tosylate wipes in patients with primary axillary hyperhidrosis. In these trials, the impact of a patient’s excessive sweating and the impact of glycopyrronium tosylate treatment were measured using the Axillary Sweating Daily Diary (ASDD), a new patient reported outcomes (PRO) instrument that is part of a multi-faceted assessment tool called the Axillary Hyperhidrosis Patient Measures (AHPM). Despite the prevalence of hyperhidrosis, no validated disease-specific measures have assessed what impact a particular therapy has on a person’s quality of life following treatment.
The AHPM consists of:
- The Axillary Sweating Daily Diary (ASDD), the new patient-reported outcomes (PRO) instrument which includes four validated items that asked patients 16 years of age and older questions about their excessive sweating and its impact on their daily activities. The ASDD PRO was developed and validated in accordance with the U.S. Food and Drug Administration 2009 PRO Guidance. Of note, Item 2 of the ASDD PRO, which asked patients to assess sweating severity, was a co-primary endpoint in the Phase 3 clinical trials. The Axillary Sweating Daily Diary-Children, which consisted of two questions, was designed to assess sweating in patients between ages 9 and 16.
- The Weekly Impact Questionnaire that assessed the impact of a patient’s sweating over seven days using six distinct questions.
- The Patient Global Impression of Change, which asked the patient to rate his or her axillary sweating following study treatment.
Burden of Axillary Hyperhidrosis at Baseline Using a Patient-Reported Outcome Measure to Assess Impact on Activities and Bothersomeness (ATMOS-1 and ATMOS-2)
- More than 50% of patients who participated in ATMOS-1 and ATMOS-2 reported that their sweating at baseline was at least a 7 on an 11-point scale, where 0 represents no sweating and 10 represents worst possible sweating.
- The majority of patients who were ages 16 years and older reported being significantly impacted by their excessive sweating, with most having to avoid social interactions or take additional measures such as showering/bathing more than once a day or changing shirts during the day to manage their excessive sweating.
- More than 90% of patients in the trials reported that they were less confident because of, or embarrassed by, their excessive sweating. This finding is consistent with previous research highlighting the condition’s burden on people suffering from excessive sweating.
Patient-Reported Outcomes from Two Randomized, Double-Blind, Vehicle-Controlled Phase 3 Trials in Axillary Hyperhidrosis (ATMOS-1 and ATMOS-2)
- After four weeks, glycopyrronium tosylate-treated patients reported greater weekly average improvement on all ASDD items compared to patients who received vehicle.
- At the end of treatment period, fewer glycopyrronium tosylate-treated patients reported the occurrence of negative behaviors or feelings associated with their excessive underarm sweating, such as feeling the need to change a shirt during the day and feeling embarrassed or less confident when compared to patients receiving vehicle.
- Of the patients treated with glycopyrronium tosylate, 73.6% of the patients in ATMOS-1 and 80.4% of the patients in ATMOS-2 rated their excessive underarm sweating as much better or moderately better, compared with 38.2% and 40.6% of vehicle-treated patients in the trials, respectively, representing a two-fold improvement.
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 15.3 million people. 1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary disease). Other 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
About Glycopyrronium Tosylate
Glycopyrronium tosylate is a once-daily anticholinergic agent, administered as a topical wipe, which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis. Glycopyrronium tosylate is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
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 candidates that could have a profound impact on the lives of patients: CIMZIA® (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. 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.
Dermira Forward-Looking Statements
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 potential approval of glycopyrronium tosylate for the treatment of excessive underarm sweating; and glycopyrronium tosylate potentially reducing the burden of disease for patients with excessive underarm sweating. 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.
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