- Daily treatment with glycopyrronium tosylate in the Phase 3, open-label ARIDO trial was generally well-tolerated during 44 weeks of treatment
- Efficacy assessment suggests sweat reduction levels were maintained in patients treated with glycopyrronium tosylate during the extended study
MENLO PARK, Calif., Oct. 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 highlighted results from ARIDO, a Phase 3 open-label extension study. ARIDO assessed the long-term safety of topical, once-daily treatment with glycopyrronium tosylate in patients with primary axillary hyperhidrosis (excessive underarm sweating), a medical condition that results in sweating beyond what is needed for normal body temperature regulation.
After an additional 44 weeks of treatment, glycopyrronium tosylate was generally well-tolerated by most patients with a low rate of discontinuation attributed to treatment-emergent adverse events (TEAEs)*. These findings were consistent with those observed in previous trials. An efficacy assessment also suggests that patients treated with glycopyrronium tosylate in ARIDO experienced a sustained response to the investigational therapy during the 44-week treatment period. The newly reported findings were presented at the 36th Annual Fall Clinical Dermatology Conference taking place in Las Vegas, October 12-15.
Glycopyrronium tosylate is an anticholinergic agent, formulated for once-daily application using a topical wipe. Glycopyrronium tosylate is designed to block sweat production by inhibiting the receptors responsible for sweat gland activation.
"The findings from the ARIDO study are important in that they further demonstrate that glycopyrronium tosylate is generally well-tolerated, with a side-effect profile that is consistent with earlier studies," said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. "We are also encouraged that the efficacy assessment conducted at the end of ARIDO suggests that patients continued to respond to topical treatment with glycopyrronium tosylate during the treatment extension period. People suffering from hyperhidrosis are in need of new treatment alternatives and it is our hope that glycopyrronium tosylate might one day be an option for people living with this condition, which has been shown to have a profound effect on quality of life."
ARIDO was designed to assess the long-term safety of glycopyrronium tosylate in adolescent and adult patients (ages nine and older) who participated in ATMOS-1 and ATMOS-2, two identical, Phase 3 clinical trials, which evaluated the safety and efficacy of the investigational therapy compared to vehicle for primary axillary hyperhidrosis over a four-week treatment period. Results from the ATMOS-1 and ATMOS-2 trials were reported in June 2016.
Patients from the ATMOS-1 and ATMOS-2 trials were permitted to enroll in ARIDO to receive up to an additional 44 weeks of treatment with glycopyrronium tosylate. The majority of patients who completed the trials, or approximately 86.6% of patients (n=564), opted to receive treatment with glycopyrronium tosylate as part of the ARIDO study. Of the patients enrolled in ARIDO, 16.3% (n=92) were lost to follow-up, 14.5% (n=82) withdrew their consent, 7.8% (n=44) discontinued due to an adverse event and 2.5% (n=14) discontinued for other reasons. Additionally, 18.8% (n=106) were discontinued on treatment as Dermira terminated the study early, having met its objective of enrolling at least 100 patients who received treatment with glycopyrronium tosylate for at least 12 months. As a result, at the conclusion of the 44-week treatment period, 40.1% of patients (n=226) completed ARIDO.
Phase 3 ARIDO Study Outcomes
- After an additional 44 weeks of treatment, 59.8% of patients (n=329) reported one or more TEAE, and most were considered mild or moderate in severity. The most frequently reported TEAEs observed in patients were dry mouth (16.9%; n=93), blurred vision (6.7%; n=37), application site pain (6.4%; n=35), the common cold (5.8%; n=32) and pupil dilation (5.3%; n=29). Prespecified anticholinergic TEAEs of interest, defined as those associated with a subset of anticholinergic side effects, were reported in 14.2% of patients (n=78) and most were mild or moderate in severity and were able to be managed by dose interruption. Serious TEAEs were reported in 1.3% of patients (n=7). The incidence of TEAEs, including prespecified anticholinergic TEAEs of interest, did not increase over time with longer duration of glycopyrronium treatment.
- An efficacy assessment conducted at the end of the treatment period in ARIDO suggests that patients who received glycopyrronium tosylate and completed the 44-week follow-up period maintained reduced sweat production compared to baseline and reported less bothersome sweating compared to baseline measures in ATMOS-1 and ATMOS-2. Notably, mean sweat production decreased by 95.77 ±140.8 mg/5 min and 63.2% of patients had ≥2-grade improvement in the Hyperhidrosis Disease Severity Scale (HDSS).
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). 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, for which Dermira 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 four late-stage product 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), for which a Phase 3 program has been completed for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris; and lebrikizumab, for which Dermira plans to initiate a Phase 2b dose-ranging study 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.
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 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 a treatment option for people living with hyperhidrosis; and Dermira's plan to initiate a Phase 2b dose-ranging study of lebrikizumab 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; 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.
1. Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
2. 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.
3. Augustin et. al., Prevalence and disease burden of hyperhidrosis in the adult population. Dermatology. 227: 10-13, 2013.
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Robert H. Uhl
Source: Dermira, Inc.