RegenCell BioScience Holdings (RGC)

[shinhari1309]

$RGC Is Developing A Breakthrough Approach To ADHD And ASD

Traditional “western” medicine has made amazing advances and is one of the great innovations in history, but, unfortunately, there are still many conditions afflicting people that western medicine hasn’t been able to treat with any great effectiveness. It’s in instances like these that it can be beneficial to look to a medical approach that’s been around for over 2,000 years—a practice known as Traditional Chinese Medicine (TCM). It’s this approach that Regencell (NASDAQ:RGC) is embracing to improve the lives of the millions dealing with Attention Deficit Hyperactive Disorder (ADHD) and Autism Spectrum Disease (ASD) and an approach that has shown some encouraging improvements that sufferers of these conditions and their families are likely to be interested in.

The market that Regencell is attempting to address is even larger as they are likely to enter the Chinese and Hong Kong markets as well. One interesting difference to pay attention to as Regencell moves forward is that a treatment such as this can enter the US market as a nutritional product and therefore requires no governmental approval, reducing the barriers to entry in the US. In China and Hong Kong, however, a Proprietary Chinese Medicine (PCM) designation is needed for the product to be sold, a situation the company is well versed in and will pursue as the treatment gets closer to being ready for commercialization.

The company just completed the second efficacy trial, which was designed to evaluate and assess the effectiveness of Regencell’s standardized TCM formula in reducing ADHD and ASD symptoms during the course of a 3-month treatment. The trial is a non-blinded efficacy trial and patients in the trial were between 6 and 12 at the time of the treatment and clinically diagnosed with ADHD and/or ASD. The program required all patients to stop their existing medications, attend weekly treatment sessions with their parents, and follow the TCM Practitioner’s dietary guidelines during the 3-month treatment. Regencell selected 7 children (6 males and 1 female) to participate in the trial. 3 of the patients were diagnosed with ADHD and 4 of them with ASD.

The first results from this trial were just released and showed encouraging improvements. When dealing with these conditions, the company used three different methods to measure improvement:

• SKATBT-A3—48-item questionnaire designed and developed by Regencell to evaluate the effectiveness of a treatment in improving ADHD and ASD patients’ symptoms. SKATBT-A3 assesses a patient’s overall physical and neurodevelopmental conditions. SKATBT-A3 includes elements that are conditions of patients usually observed during TCM treatments such as: (i) speech/language/communication; (ii) patients’ sociability; (iii) sensory/cognitive awareness; and (iv) physical health and behavior.

• VADRS—a tool commonly used to measure ADHD severity.

• ATEC—The ATEC was designed as a comparative subscale for ASD diagnosed individuals – that is to measure change in ASD individuals due to various interventions by difference between the initial (baseline) ATEC scores and later ATEC scores.

All patients orally consumed the standardized TCM formula twice daily for 3 months. Improvements in patients’ symptoms were assessed weekly during treatment review sessions with the TCM Practitioner and the children’s parents.

And here’s the exciting part, after three months, the SKATBT-A3 scores of all patients were lower, indicating fewer problems and improvements in symptoms. According to the company, there were noticeable improvements in the patients’ overall health, ADHD symptoms and ASD symptoms. Common improvements noted included better sleep quality, reduced temper, better bowel movement and healthier complexion. The most notable improvement was demonstrated by two patients who gained the ability to control their tongues naturally without the aid of their own hands after the 3-month treatment. According to company management, this development is noteworthy because limited tongue function affects verbal communications and language abilities.

Improvement was also seen in the measures not designed by Regencell, with the VADRS scores of five patients coming in lower, indicating fewer problems and improvements in symptoms, while one patient’s score remained the same and one patient’s score was higher. Percentage improvements of patients ranged between -21% and 62%, with a mean of 21%. Additionally, the ATEC scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of all patients ranged between 4% and 52%, with a mean of 22%. The company provided some color on the ATEC results and noted that they saw the most significant drop in scores in the health/physical/behavior subscale. Constipation, sleeping problems, poor appetite, anxiety/fearfulness, and irritability are common issues among ADHD and ASD patients and according to Regencell most of the patients suffered from these symptoms before the treatment but these symptoms improved after the treatment.

Importantly, none of the patients experienced any adverse side effects after the 3-month treatment. Additionally, while no guarantees can be made, herbal TCM treatments have an accumulating effect, meaning that while the greatest gains may be seen during the initial months of treatment, progress can be expected to continue the longer treatment is maintained.

While these are trials and there are no conclusions yet, the results seen so far warrant attention and we recommend investors to continue to monitor Regencell’s updates and developments. We are excited for the potential impact and market opportunity of the treatment.

https://scr.zacks.com/news/news-details/2022/RGC-Forging-a-New-Approach-to-ADHD-and-ASD/default.aspx