The outcome of a pilot study of BBI-4000, new compound for the topical treatment of primary axillary hyperhidrosis, support the potential for BBI-4000 to become a safe and effective treatment option for people suffering from excessive sweating. BBI-4000 is a new molecular entity from Brickell Biotech—a “soft anticholinergic” designed to be therapeutically active in the skin and rapidly metabolized if absorbed into the body, minimizing potential systemic side effects.
In the parallel group part of this double-blind clinical study, 18 subjects with primary axillary hyperhidrosis were randomized to a high topical concentration of BBI-4000, a low topical concentration of BBI-4000, or to topical vehicle, with 6 subjects in each group. The preliminary data show that 75% (9/12) of subjects receiving BBI-4000 achieved more than 50% sweat reduction compared to 33% (2/6) of the subjects in the vehicle group. In addition, 67% (8/12) of subjects receiving BBI-4000 reported a substantial (≥ 2 point) improvement in their score on the Hyperhidrosis Disease Severity Scale, in comparison with 33% (2/6) of subjects in the vehicle group. These endpoints are considered clinically relevant and have been used in the regulatory evaluation and product labeling of an approved product for hyperhidrosis. Additionally, there were no treatment-related adverse effects or discontinuations due to adverse events. This pilot trial, though not designed to demonstrate statistical significance, did meet its objectives of indicating preliminary efficacy, local tolerability, and systemic safety and for informing the design and conduct of clinical trial work that the company is planning for the future.