This application for a Fast Track STTR award represents a collaboration between Natural Pharmacia International, Inc. (NPI) and McLean Hospital to initiate steps toward commercializing a isoflavone botanical product for treating alcoholism. Excessive use of alcohol accounts for much of the public health burden related to alcohol use disorders, including fetal alcohol syndrome, fatal motor crashes, accidents and homicides. On college campuses alone, alcohol use results annually in almost 2,000 deaths, 100,000 sexual assaults, 600,000 injuries, and 700,000 assaults. For most, problematic drinking and its associated morbidity will not be brought to the attention of Primary Care Professionals and so many go without treatment. This is precisely where an OTC herbal product could have the greatest impact. An extract of kudzu (Pueraria lobata) has been patented by McLean Hospital and licensed it to NPI under the name Alkontrol-herbal. Over the past 13 years, our team has extensively studied this kudzu extract and demonstrated its safety and efficacy in healthy control subjects as well as in heavy binge drinkers. The reason for pursuing the STTR mechanism is two-fold: 1) while NPI has been able to produce enough product for our modest clinical studies, they are not in a position to ramp up full production in order to support larger scale clinical trials; and 2) we have conducted and published 6 studies in human subjects, but we have yet to conduct a study in heavy drinkers who are alcohol-dependent and are treatment-seeking. Thus, there is a significant need for this clinical trial to demonstrate efficacy in this important population. The reason for the Fast Track approach is that we have already developed product, licensed it to NPI, and have the backbone of a commercialization plan, but need fiscal support to develop the processes needed to increase production of enough standardized product to support not only the clinical trial, but to be able to meet the needs once the commercialization plan is implemented. Thus Phase I will be focused on providing NPI with the infrastructure to scale up production of standardized, high quality Alkontrolherbal while the clinical trial will be the major milestone of Phase II. Collectively, successful completion of these two phases will pave the way for the commercialization of Alkontrol-herbal. Key milestones for Phase I include: procure and authenticate Pueraria lobata from our source in China, perform GMP extraction and precipitation, develop independent QC analytical protocols, optimize ratio of isoflavones, and finalize submission of an IND for FDA-approved labeling and IRB applications. Phase II milestones include: scale up production of Alkontrolherbal, isolate puerarin for standardization, develop a urinary biomarker for medication adherence and conduct proof-of-concept clinical trial in treatment-seeking alcohol-dependent individuals.
The proposed STTR project represents a collaboration between the small business Natural Pharmacia International, Inc. and McLean Hospital to ramp up production of Alkontrol-herbal and conduct a clinical trial in treatment-seeking alcohol dependent, heavy-drinking individuals.