Dermira, Inc., a biopharmaceutical company, engages in identifying, developing, and commercializing therapies to enhance the lives of patients with dermatologic diseases primarily in the United States. The company’s late-stage product candidates comprise Cimzia, an injectable biologic tumor necrosis factor-alpha inhibitor, which is in Phase III clinical trial for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, a small-molecule anticholinergic product that is in Phase III clinical trial for the treatment of primary axillary hyperhidrosis or excessive underarm sweating; and DRM01, a small-molecule sebum inhibitor, which is in Phase IIb clinical trial for the treatment of a...
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Menlo Park, CA 94025
Founded in 2010
Dermira Mulls Acquisitions
Jun 8 16
Dermira, Inc. is lloking for acquisitions. The company which has offered 4.5 million common stocks, intends to use the net proceeds for expand business by in-licensing or acquiring, as the case may be, commercial products, product candidates, technologies, compounds, other assets or complementary businesses.
Dermira, Inc. - Special Call
Jun 1 16
To discuss Results from two pivotal phase 3 clinical trials for DRM04 in patients with primary axillary hyperhidrosis
Dermira, Inc. Announces Positive Results from Two Pivotal Phase 3 Clinical Trials for DRM04 in Patients with Primary Axillary Hyperhidrosis
Jun 1 16
Dermira, Inc. announced topline results from its Phase 3 ATMOS-1 and ATMOS-2 pivotal trials for DRM04, a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis (excessive underarm sweating). Both clinical trials evaluated the safety and efficacy of DRM04 compared to vehicle. In the ATMOS-2 trial, DRM04 demonstrated statistically significant improvements for both co-primary endpoints and both secondary endpoints compared to vehicle. In the ATMOS-1 trial, DRM04 demonstrated statistically significant improvements for one of the co-primary endpoints and both secondary endpoints. These results were based on the overall dataset from the intent-to-treat population. For the second co-primary endpoint in the ATMOS-1 trial, when extreme outlier data from one analysis center were excluded in accordance with the pre-specified statistical analysis plan submitted to the U.S. Food and Drug Administration (FDA), DRM04 demonstrated statistically significant results compared to vehicle. Consistent with previous results, DRM04 was generally well-tolerated with side effects that were primarily mild to moderate in severity. Based on the results of these trials, Dermira plans to submit a New Drug Application (NDA) to the FDA for potential approval of DRM04. The NDA submission is targeted for the second half of 2017, subject to the completion of the Phase 3 ARIDO trial, an open-label trial assessing the long-term safety of DRM04, other registration-enabling activities and a pre-NDA meeting with the FDA. The co-primary endpoints for the ATMOS-1 and ATMOS-2 Phase 3 trials were the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument, and the average absolute change from baseline in gravimetrically-measured sweat production. The secondary endpoints in both trials measured the proportion of patients who had at least a two-grade improvement from baseline as measured by the Hyperhidrosis Disease Severity Scale (HDSS) and the proportion of patients with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Each endpoint was measured at the end of the four-week treatment period. ATMOS-1 Results: The proportion of patients who achieved at least a four-point improvement in sweating severity, as measured by the ASDD, was 52.8% in DRM04-treated patients, compared to 28.3% in patients who received the vehicle only (p<0.001). The average reduction in sweat production was 104.9 mg in patients treated with DRM04 as compared to 91.9 mg in vehicle-treated patients based on the overall dataset from the intent-to-treat population (p=0.065). As outlined in the pre-specified statistical analysis plan submitted to the FDA, a sensitivity analysis was conducted that led to the exclusion of an analysis center with extreme outlier data for the gravimetric measurement of sweat. This analysis center consisted of 14 patients, of whom nine were treated with DRM04 and five received vehicle only. Following the exclusion of this analysis center, patients treated with DRM04 demonstrated an average reduction in sweat production of 96.2 mg as compared to 90.6 mg in patients who received the vehicle only (p=0.001). The proportion of patients who achieved at least a two-grade improvement in HDSS score, a secondary endpoint, was 56.5% in patients treated with DRM04 as compared to 23.7% in patients who received the vehicle only (p=0.001). The proportion of patients with at least a 50% reduction from baseline in gravimetrically-measured sweat production, a secondary endpoint, was 72.4% in patients treated with DRM04 as compared to 53.2% in patients who received the vehicle only pAbout the DRM04 Phase 3 Clinical Program ATMOS-1 and ATMOS-2 were designed as identical, multi-center, randomized, double-blind, vehicle-controlled trials to assess the safety and efficacy of DRM04 at a concentration of 3.75% compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis. The ATMOS-1 trial enrolled 344 patients at 29 sites in the United States and Germany, and the ATMOS-2 trial enrolled 353 patients at 20 sites in the United States. Inclusion criteria required that prior to the start of treatment, all patients produce at least 50 mg of sweat in each underarm over a five-minute period and rate the severity of their sweating as a four or higher on the 11-point ASDD scale and as a three or a four on the four-grade HDSS. In the ATMOS-1 trial, 229 patients were randomized to receive DRM04 and 115 patients were randomized to receive vehicle; and in the ATMOS-2 trial, 234 patients were randomized to receive DRM04 and 119 patients were randomized to receive vehicle. Patients were instructed to apply the study product to each underarm once daily for four weeks using topical wipes containing either DRM04 or vehicle only. In addition to the ATMOS-1 and ATMOS-2 trials, Dermira is also conducting ARIDO, an open-label trial assessing the long-term safety of DRM04 as part of its Phase 3 program to provide safety data for a minimum of 100 patients who have received DRM04 for at least 12 months per the International Council on Harmonization guidelines. Patients from the ATMOS-1 and ATMOS-2 trials were permitted to enroll in the ARIDO trial and continue to receive DRM04 (active treatment) for up to an additional 44 weeks from the end of the four-week treatment periods in the ATMOS-1 or ATMOS-2 trials. A total of 564 patients, more than 80%, elected to enroll in ARIDO. Dermira expects to complete the treatment period for the ARIDO trial by the end of 2016. Hyperhidrosis is a condition of sweating beyond what is physiologically required to maintain normal thermal regulation. Primary hyperhidrosis, which is excessive sweating without a known cause, can affect the underarms, palms of the hands, soles of the feet, face and other areas. DRM04 is a topical anticholinergic product currently in clinical development for the treatment of primary axillary hyperhidrosis. DRM04 is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.