Two Identical Studies to Enroll a Combined Total of 660 Patients
Topline Phase 3 Data Expected in the Second Half of 2016
Represents Dermira's Second Product Candidate in Phase 3 Development
Dermira Updates 2015 Financial Guidance
MENLO PARK, Calif., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the initial dosing of the first patients in a Phase 3 program for DRM04 in patients with axillary hyperhidrosis (excessive underarm sweating). The DRM04 Phase 3 program consists of two identical, randomized, double-blind, vehicle-controlled studies, ATMOS-1 and ATMOS-2, each enrolling approximately 330 patients. The program is designed to assess the safety and efficacy of DRM04 compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).
"The initiation of this Phase 3 program marks an important milestone for Dermira's DRM04 program and the millions of patients suffering from hyperhidrosis," stated Tom Wiggans, chairman and chief executive officer of Dermira. "The results of our completed Phase 2 program comprising three randomized, double-blind, vehicle-controlled clinical trials in 341 patients and our end-of-phase 2 meeting with the FDA have informed the trial design and clinical endpoints for this Phase 3 program. With the initiation of this DRM04 Phase 3 program, for which we expect topline data in the second half of 2016, we now have advanced two of our three late-stage product candidates into Phase 3 development."
DRM04 Phase 3 Clinical Program
A total of 660 adult and adolescent (9+ years) patients with primary axillary hyperhidrosis will be enrolled in two identical Phase 3 trials, ATMOS-1 and ATMOS-2, being conducted at approximately 60 sites in the United States and Germany. Subjects will be randomized into two separate arms evaluating DRM04 compared to vehicle. In each trial, 220 patients will receive DRM04 and 110 patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only.
The co-primary endpoints will be the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company's proprietary patient-reported outcome (PRO) instrument. Each of these endpoints will be measured at the end of the four-week treatment period. Based on discussions with the FDA, Dermira developed and validated the ASDD instrument in accordance with the 2009 FDA guidance document for PRO measures. The ASDD endpoint, a 4-point change on an 11-point scale, was selected based on analyses of data generated in the second Phase 2b Study, DRM04-HH02, and feedback from the FDA. Secondary efficacy endpoints will measure the proportion of subjects who have at least a two-grade improvement from baseline as measured by the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production, each as measured at the end of the four-week treatment period.
Topline results from ATMOS-1 and ATMOS-2 are expected during the second half of 2016. The Phase 3 program also will include an open-label study, ARIDO, assessing the long-term safety of DRM04, in which patients from either of the Phase 3 studies will be permitted to continue to receive treatment for up to an additional 44 weeks.
DRM04 is a topical formulation of a novel form of an anticholinergic agent, which is referred to as the reference agent, that has been approved for systemic administration in other indications. The DRM04 dose being evaluated in the Phase 3 program is a 3.75% concentration of Dermira's novel form of the reference agent, which was evaluated in Study DRM04-HH02 and corresponds to the 3% dosage formulation of the reference agent evaluated in both Study DRM04-HH02 and the first Phase 2b study (DRM04-HH01).
DRM04 is a topical, small-molecule, anticholinergic product in clinical development for the treatment of hyperhidrosis. DRM04 is designed to inhibit sweat production by blocking the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
Hyperhidrosis is a condition of sweating beyond what is physiologically required to maintain normal thermal regulation. It can affect the axillae (underarms), palms of the hands, soles of the feet, face and other areas. In the United States, based on the most recent data available, the prevalence of hyperhidrosis was estimated in 2003 to be 2.8% of the population, or roughly 7.8 million people.
2015 Financial Guidance
Management expects that GAAP operating expenses for 2015 will be in the range of $86-91 million. In addition, management reiterates its expectations for 2015 that non-GAAP operating expenses, excluding the impact of stock-based compensation expense of approximately $6 million, will be in the range of $80-85 million. Consistent with previous guidance, of the total expected operating expenses for 2015, management expects research and development expenses to comprise approximately 75% and general and administrative expenses to comprise the remaining 25%. Management also expects that research and development and total operating expenses in the second half of 2015 will be significantly higher than in the first half of the year.
Dermira is a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients. Dermira's portfolio of five product candidates targets significant market opportunities and includes three late-stage product candidates: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe plaque psoriasis; DRM04, in Phase 3 development for the treatment of axillary hyperhidrosis; and DRM01, in Phase 2b development for the treatment of acne. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
Use of Non-GAAP Measures
Dermira is reiterating its expectations with respect to its 2015 non-GAAP operating expenses that do not include stock-based compensation expense. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with U.S. GAAP. Dermira's management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes the non-GAAP information is useful to investors as they provide a basis for evaluating Dermira's cash requirements and additional insight into the underlying operating results and Dermira's ongoing performance in the ordinary course of its operations.
This non-GAAP measure may be different from non-GAAP measures used by other companies. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. Dermira believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with U.S. GAAP and that these measures should only be used to evaluate Dermira's results of operations in conjunction with the corresponding GAAP measures.
Dermira excludes stock-based compensation expense from its non-GAAP operating expenses, which consists primarily of expenses for stock options under Accounting Standards Codification 718, Compensation–Stock Compensation. Dermira excludes stock-based compensation expense from its non-GAAP operating expense measure primarily because it is a non-cash expense that Dermira does not believe is reflective of ongoing operating results in the period incurred.
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, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, 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 with respect to the DRM04 mechanism of action, enrollment of the Phase 3 clinical trials, expected size, dosage specifics and other details of the trials, and when the topline results of the Phase 3 program will be available, as well as expected operating expenses, including on a non-GAAP basis, and stock-based compensation expenses for 2015, the composition of the operating expenses and the allocation of the operating expenses between the first half of 2015 and second half of 2015. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our 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 outcomes of our clinical trials, our dependence on third-party clinical research organizations, manufacturers and suppliers, regulatory compliance with respect to the design and implementation of our clinical trials, our ability to obtain regulatory approval for our product candidates, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled "Risk Factors" set forth in the Company's Annual Report on Form 10-K, the Company's Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake 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.
CONTACT: Dermira Contact
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl