Positive topline results were announced from 2 identical phase 3 studies evaluating sofpironium bromide in patients with primary axillary hyperhidrosis.

Sofpironium bromide is a structural analogue of glycopyrrolate, an anticholinergic agent. It is designed to selectively bind to M3 AC receptors in sweat glands, thereby inhibiting sweat production.

The multicenter, randomized, double-blind, vehicle-controlled Cardigan I (ClinicalTrials.gov Identifier: NCT03836287) and Cardigan II (ClinicalTrials.gov Identifier: NCT03948646) studies evaluated the efficacy and safety of sofpironium bromide in 350 and 351 patients, respectively, aged 9 years and older with primary axillary hyperhidrosis. Patients were randomly assigned 1:1 to receive either sofpironium bromide gel 15% or vehicle applied topically to the underarms once daily at bedtime for 6 consecutive weeks.

Results from the Cardigan I study showed that 49.3% of patients treated with sofpironium bromide achieved at least a 2-point improvement in the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax) score from baseline to end of treatment (EOT) compared with 29.4% of those treated with vehicle (P <.001). Moreover, patients in the sofpironium bromide arm had a greater change in the measured weight (in mg) of gravimetric sweat production (GSP) from baseline to EOT compared with the vehicle arm (-129.5 vs -99.3, respectively; P =.002).


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In the Cardigan II study, 63.9% of patients treated with sofpironium bromide achieved at least a 2-point improvement in the HDSM-Ax score from baseline to EOT compared with 47% of those treated with vehicle (P =.003). Patients in the sofpironium bromide arm also had a greater change in the measured weight (in mg) of GSP from baseline to end of treatment compared with those in the vehicle arm (-145.9 vs -131.7, respectively; P =.03).

Additionally, both trials met all secondary efficacy endpoints including: the proportion of patients achieving at least a 1-point improvement in the HDSM-Ax score from baseline to EOT; the proportion of patients achieving at least a 2-point improvement in the HDSM-Ax score and at least a 70% reduction in GSP from baseline to EOT; and the proportion of patients achieving at least a 1-point improvement in the HDSM-Ax score and at least a 50% reduction in GSP from baseline to EOT.

As for safety, sofpironium bromide was generally well tolerated; the most common adverse events included dry mouth, blurred vision, application site reactions (pain, erythema, pruritus, dermatitis, irritation), mydriasis, urinary retention, dry eye, headache, constipation, and urinary hesitation. The treatment-emergent adverse events were mild or moderate in severity and transient in nature.

“These data demonstrate that once-daily topical sofpironium bromide gel, 15% achieved early, sustained and significant improvements in primary axillary hyperhidrosis signs and symptoms consistent across all efficacy measures and was generally well tolerated over 6 weeks of treatment,” said Stacy Smith, MD, a practicing dermatologist and principal investigator in the US phase 3 program.

References

  1. Brickell Biotech announces positive topline results, achieving statistical significance on all primary and secondary endpoints, from both US phase 3 pivotal clinical studies of sofpironium bromide gel, 15% in primary axillary hyperhidrosis patients. News release. Brickell Biotech, Inc. Accessed October 7, 2021. https://www.globenewswire.com/news-release/2021/10/07/2310180/0/en/Brickell-Biotech-Announces-Positive-Topline-Results-Achieving-Statistical-Significance-on-all-Primary-and-Secondary-Endpoints-from-Both-U-S-Phase-3-Pivotal-Clinical-Studies-of-Sofp.html
  2. Pipeline: Sofpironium Bromide. Brickell Biotech, Inc. Accessed October 7, 2021. https://brickellbio.com/rd/pipeline/sofpironium-bromide/.