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Tuesday, 06/09/2020 1:10:05 PM

Tuesday, June 09, 2020 1:10:05 PM

Post# of 507
Status of Development of SUGARDOWN®
We completed development of SUGARDOWN® as an over the counter (OTC) US dietary supplement. We filed a structure and function claim application with the United States Food and Drug Administration (FDA) with respect to SUGARDOWN®, which describes the proposed mechanism of action of SUGARDOWN® in reducing post-meal elevation of glucose in the blood. We have submitted thirty structural and functional claims with the FDA. We currently have strategically received awarded patents that are directed to the Composition of purified mannans, which are utilized in the formulation of SUGARDOWN®. We have also received a registered mark for SUGARDOWN®. General Product Liability Insurance for SUGARDOWN® has been in effect since April 2010. On January 24, 2012, we announced the clinical test results in healthy volunteers performed at the Sydney University Glycemic Institute for Research with SUGARDOWN®. On January 28, 2013, we announced the final results of the study conducted at the University of Sydney that showed the post- meal incremental area under the curve (iAUC) for glucose and insulin were significantly lower following consumption of SUGARDOWN® tablets prior to a high carbohydrate meal of rice in a dose-dependent manner. This resulted in a reduction of up to 61% in post-meal elevation of blood glucose compared with the rice consumed alone. On average, there was a 25.5% reduction in the post-meal iAUC for glucose and a 20% reduction in post-meal insulin response for the 10 volunteers in the study. No severe adverse effects were reported or observed during the study. As of December 2019 we have been party to the completion of several additional clinical trials all supported by Clinical.trials.gov. and we are publishing to secure a standing and to confirm the integrity of the data. In the first half of 2020 we anticipate the announcement of the phase 2 exploratory trial for our pivitol phase 3. This is anticipated to confirm the safety and efficacy for the potential drug filing of the investigative materials.
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https://www.sec.gov/Archives/edgar/data/1473579/000121390020014377/f10k2019_bostontherapeutics.htm

Results any day now....