Dermira Presents Positive Data on Treating Pediatric Patients with Axillary Hyperhidrosis

Dermira, Inc. presented new findings from its glycopyrronium tosylate (formerly DRM04) Phase 3 clinical program showing 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, consistent with results previously reported in adult patients (ages 17 and older), were featured in an oral presentation during the Late-Breaking Research Forums at the 76^th Annual Meeting of the American Academy of Dermatology (AAD) in San Diego.

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,” says Adelaide Hebert, MD, 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.”

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,” says Eugene A. Bauer, MD, 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.”