New Hh Treatment Approved in Japan, A Topical Rx for Underarms in Final Studies in USA & Hh Treatment Developer Involved in COVID-19 Vaccine Research
The International Hyperhidrosis Society (IHhS) has done a deep dive into clinical trials and pipeline reports and compiled a comprehensive report on current research related to the management of hyperhidrosis. The full report covers more than 20 treatment-focused studies and is so meaty we can’t do it justice in one blog. The great news is that, after reading this installment, you have two more research updates to check out. Please note that all of this information is publicly available, although not from one easily-digestible source. Except here!
Making It Gel: Brickell Biotech & Sofpironium Bromide/BBI-4000
To start, we’re covering a treatment in the final stages of development right now: a new topical (i.e. applied on top of the skin) anticholinergic from Brickell Biotech. (For news about the prescription topical anticholinergic Qbrexza® already available in the U.S.A. and Canada, watch for Part 2 of this research report coming soon!)
Last summer, Brickell Biotech released important results regarding its topical gel (sofpironium bromide/BBI-4000) for patients with primary axillary hyperhidrosis (Hh or underarm excessive sweating). The data was reported in June 2020 in the Journal of the American Academy of Dermatology in an article called “Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded Trial." It showed that sofpironium bromide at three different strengths (5%, 10%, and 15%) was well tolerated (in this case, “tolerability” refers to the degree to which side effects of the treatment were handled by patients using it so that they didn’t feel like they needed to stop using it) and produced significant as well as lasting reductions in underarm sweating. The most common side effects reported were dry mouth and blurred vision (both expected anticholinergic side effects). These were usually mild or moderate and temporary.
More recently, scientists at Brickell Biotech presented the results of four additional studies at virtual medical meetings (Fall Clinical Virtual Grand Rounds, Winter Clinical Virtual 2021, and Maui Derm). These studies looked at whether the use of sofpironium bromide/BBI-4000 in high doses on different body areas, both with and without occlusion, would cause systemic reactions (negative side effects to other organs or parts of the body besides the skin, such as the heart). It should be noted that the high (“supra”) doses and application techniques used in these studies are NOT how the product is designed to be used but was for safety testing only. Even under these extremes, the research found BBI-4000 to be safe and generally well-tolerated, with no remarkable findings in the safety assessments of the adult patients involved. One of the things the studies looked at was whether the very high doses of the medication would affect the heart at all, but they found no changes in heart rate or other key heart assessments.
Sofpironium Bromide/BBI-4000 for Children with Hh
Another of the recent studies looked at the use of sofpironium bromide/BBI-4000 for 21 children aged 9 to 16 years suffering from primary axillary hyperhidrosis (underarm excessive sweating). The young people with Hh in this study used sofpironium bromide for more than 5 months with no severe or serious side effects and reported meaningful improvement in their underarm sweating symptoms (an approximately 65% improvement in how they described their sweating severity). Two participants did, however, stop using the skin treatment due to dry eyes, dry mouth, itching, and rash.
As of August 2021, sofpironium bromide/BBI-4000 has completed two Phase 3 trials in the USA. The two trials (called “Cardigan I” and “Cardigan II”) lasted eight weeks (per participant) and included about 350 hyperhidrosis sufferers each. Study volunteers were aged nine years and older and all were diagnosed with primary axillary hyperhidrosis. As many readers already know, Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials (like those described above) and to compare the new product to other standard therapies. Phase 3 trials also look at the overall risks and benefits of a new treatment. For its Phase 3 USA trials, Brickell used the strongest of the three sofpironium bromide concentrations it’s been studying (15%). IHhS was proud to help recruit trial participants. Brickell plans to announce key results from Cardigan I and Cardigan II in the fourth quarter of 2021. If all goes as expected, Brickell also plans to submit a New Drug Application (NDA) for sofpironium bromide gel, 15% to the U.S. FDA in mid-2022.
ECCLOCK® (Sofpironium Bromide 5%) Approved in Japan
In Japan, Brickell's development partner, Kaken Pharmaceutical Co. Ltd., has already been approved to market sofpironium bromide at a lower strength (5% concentration) for patients with primary axillary Hh. Going by the brand name ECCLOCK®, the product is the first topical prescription product to be approved in Japan for the treatment of primary axillary hyperhidrosis. In addition to Japan, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China, and certain other Asian countries.
Phase 3 study results for ECCLOCK® were shared as late-breaking research at the 2020 American Academy of Dermatology Virtual Annual Meeting and in the Japanese Dermatological Association’s Journal of Dermatology. In the research, 281 Japanese patients were randomized to either apply sofpironium bromide gel 5% or a placebo gel to their underarms for 42 days. All of the subjects involved in the study had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or higher and measurements of sweat production per minute of 50mg or above. At the end of the study, 54% of participants had improved HDSS scores (down to 1 or 2 from previous scores of 3 or more) and 50% reduction in their sweat production measurements (as compared to 36% with placebo.)
Common, mostly mild side effects (occurring in 5% or more of patients) in the sofpironium bromide gel group were nasopharyngitis (cold symptoms) (14.2%), dermatitis (itchy, red or rashy skin) in the underarms (8.5%), and erythema (redness) at the application site (5.7%). Also, a small percentage of those (2.8%) in the treatment group experienced anticholinergic-class side effects such as dry mouth (1.4%), constipation (0.7%), and mydriasis (dilation of the pupils of the eye) (0.7%).
Do You Want to Help with Hh Research?
For Hh sufferers, getting involved in research can be a potential path to treatment and a satisfying way to give back to the community that’s striving to make a difference in the excessive sweating world. To brush up on the basics of clinical trials, click here.
For researchers and organizations conducting clinical, market, or educational research, the International Hyperhidrosis Society is here to help you find participants for trials. Whether your search is targeted or broad, get in touch to learn how we can make the process smooth, efficient, and successful. Making connections across the miles, across disciplines, and across the bench is central to all we do.
Motivated to read the latest medical journal articles and study outcomes related to hyperhidrosis so you’re totally in the know? Or, just want to catch up on the headlines of what’s happening in the world of sweat research? Be sure to visit the Published Scientific Research section on this website where we curate the most timely and relevant peer-reviewed pieces for you.
Brickell Bio & COVID-19 Vaccines
BUT WAIT here’s one more not-to-be-missed nugget of info before we go:
In a completely different therapeutic area, Brickell is working with Japanese company AnGes Inc. on a vaccine intended to prevent COVID-19 infection. AnGes was the first company in Japan to initiate a COVID-19 vaccine clinical study and is currently conducting Phase 1 and 2 trials of its vaccine candidate in Japan. Brickell is helping AnGes by providing information and know-how. If the studies go well, Brickell will then work to bring the vaccine to the United States and certain underserved countries.
There are approximately twenty hyperhidrosis-related studies going on in eight countries around the world looking at eleven different treatments (some new and some familiar options being used in new ways.) Jump to our blog list to find parts 2 and 3 of this research report.