Press Release

Confirmatory Phase 3 Study of BBI-4000 Meet Primary Endpoint- Announcement at the 119th Annual Meeting of the Japanese Dermatological Association and the 2020 Annual Meeting of American Academy of Dermatology-Jun 15, 2020

Tokyo, June 15, 2020 – Kaken Pharmaceutical Co., Ltd. announced that the positive confirmatory Phase 3 study results with BBI-4000 (generic name: sofpironium bromide) for the topical treatment of primary axillary hyperhidrosis were presented at the 119th Annual Meeting of the Japanese Dermatological Association and the 2020 Annual Meeting of American Academy of Dermatology held from June 4 through June 7, 2020 and from June 12 through June 14, 2020, respectively. The summary of Phase 3 pivotal study is given as follows:

 

The multicenter, randomized, double-blinded, vehicle-controlled confirmatory Phase 3 study in Japan was designed to evaluate the efficacy and safety of BBI-4000 vs. vehicle administered for 6 weeks in 141 and 140 subjects with primary axillary hyperhidrosis. At baseline, all subjects had Hyperhidrosis Disease Severity Scale (HDSS) of ≥3 and an axillary gravimetric sweat production (GSP) of ≥50 mg/5 min in each axilla.

 

Primary Endpoint:

・Proportion of patients whose HDSS was improved to a score of 1 or 2 at the end of treatment (EOT) and > 50% reduction in GSP from baseline at EOT was 53.9% (BBI-4000) versus 36.4% (vehicle); p = 0.003

Secondary Endpoints:

・Proportion of patients whose HDSS was improved to a score of 1 or 2 at EOT was 60.3% (BBI-4000) versus 47.9% (vehicle); p=0.036

・Change in the total GSP mean value for both axillae from baseline to EOT was -157.6 mg (BBI-4000) versus -127.6 mg (vehicle); p=0.015

・Proportion of patients with ≥50% reduction in the rate of GSP from baseline to EOT was 77.3% (BBI-4000) versus 66.4% (vehicle); p=0.042

・Change in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score from baseline to EOT was -1.41 (BBI-4000) versus -0.93 (vehicle); p=0.001

Safety:

・In this study, BBI-4000 was observed to be generally safe and well-tolerated. No serious adverse events related to BBI-4000 were reported in the study. Common adverse events (incidence ≥5%) in BBI-4000 group were nasopharyngitis (14.2%), dermatitis at the application site (8.5%), and erythema at the application site (5.7%). 2.8% of BBI-4000-treated subjects experienced any anticholinergic-class adverse events; dry mouth (1.4%), constipation (0.7%) and mydriasis (0.7%).

 

 

・About BBI-4000 (generic name: sofpironium bromide)

BBI-4000 is a new molecular entity that belongs to a class of drugs called “anticholinergics,” which exert their effect by blocking the action of acetylcholine, a molecule that transmits signals within the nervous system that are responsible for a range of bodily functions, including the activation of sweat glands. Kaken has submitted a new drug application for approval of manufacturing and marketing for BBI-4000 (generic name: sofpironium bromide) in Japan for primary axillary hyperhidrosis.

 

・About Primary Axillary Hyperhidrosis

A condition that involves heavy sweating on the armpits caused by heat, stress, or occurring without such causes, and interferes with daily life and work.

 

・About HDSS / HDSM-Ax

Hyperhidrosis disease severity score (HDSS) and hyperhidrosis disease severity measure-axillary (HDSM-Ax) is the scale to assess the severity of hyperhidrosis. The HDSS is a 4-point (1-4) scale. The HDSM-Ax is a 5-point (0-4) patient reported outcome measure with mean response scores comprised of 11 individual questions.

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