RegenCell BioScience Holdings (RGC)

[shinhari1309]

Regencell Bioscience $RGC; Upcoming results in follow-on study of ASD/ADHD treatment formula.

Founded in 2014, Hong Kong-based Regencell Bioscience (NASDAQ:RGC) is an early clinical stage bioscience company using Traditional Chinese Medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases such as the coronavirus disease (COVID-19).

Regencell Bioscience is expected to report results of a follow-on study for its ASD/ADHD treatment. Currently, the Company is working towards the production of an effective standardized formula for commercialization purposes.

The formula is based on the “Sik-Kee Au TCM Brain Theory®” that ASD and ADHD stem from inadequate blood flow and creation of neurotransmitters in the developing brain. As we discussed earlier, this hypothesis is complementary to the western medicine view that ASD and ADHD are present at birth and arise from developmental differences in brain function.

Regencell Bioscience’s first clinical trial was designed to establish benchmarks for treatment, dosing, adverse effects (AEs) and measuring patients’ response in a systematic and repeatable way, while evaluating the effectiveness of a customized TCM formula.

As a customized formula is designed to suit each patient’s symptoms, the ability for it to be produced in large quantities is limited as compared to a standardized formula. Regencell is currently evaluating and assessing the effectiveness of a standardized TCM formula in reducing ADHD and ASD symptoms in children through a holistic approach within 3 months of treatment, in its second efficacy trial.

Path to registration and commercialization

Regencell Bioscience has a four-year timeframe to commercialize its standardized formulations and gain proprietary Chinese medicine (pCm) registration in Hong Kong. The Company has a number of tasks ahead:

• Completing its second clinical trial for ASD/ADHD and COVID, and evaluating results.

• Conducting additional clinical trials to support its proprietary formulae in ASD/ADHD and other applications.

• Obtaining patents and other forms of IP protection in Hong Kong and other markets.

• Establishing manufacturing capability and supply chain that will meet registration requirements.

• Assembling and filing documentation for pCm approval.

• Build out its marketing and distribution strategy and infrastructure.

We believe that an emphasis on conducting well-designed clinical trials that measure outcomes based on well-established assessment instruments, will provide Regencell Bioscience with a competitive advantage in terms of expertise and credibility in an industry that is moving towards higher standards for efficacy, safety and quality. While there is still much work to do, in our view, Regencell Bioscience is taking a thoughtful, systematic approach to developing its TCM formulae.



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