Full Press Release Details
Regencell Bioscience's Standardized Formulae
Are Shown to Reduce ADHD and ASD Symptoms in the Interim Results of its Second Efficacy Trial
HONG KONG, September 12, 2022--(Business Wire)--Regencell
Bioscience Holdings Limited (Nasdaq: RGC) ("Regencell") today announced its interim results from its second efficacy
Regencell conducted its second efficacy trial
using standardized Traditional Chinese Medicine ("TCM") formulae. "Our aim is to save and improve lives by making
our standardized TCM formulae widely available to ADHD and ASD patients around the world. It is known that there is a significant economic
impact and increased parental burden to families that care for children with ADHD and ASD. These positive data from the second efficacy
trial bring us one step closer to improving the conditions and quality of life of patients and reducing the negative impact that ADHD
and ASD have on patients and their families," said Yat-Gai Au, founder and CEO of Regencell.
Second Efficacy Trial
The primary objective of the second efficacy trial
is to evaluate and assess the effectiveness of Regencell's standardized TCM formulae in reducing ADHD and ASD symptoms through a
holistic approach during the course of a 3-month treatment.
The second efficacy trial is a non-blinded efficacy
trial. Regencell started its recruitment program in August 2021 through direct invitations to members of a non-governmental organization
that serves the ADHD and ASD community. Parents and guardians of children with ADHD and ASD were invited to apply for the program.
Patients between the ages of 6 and 12 at the time
of the treatment and who were clinically diagnosed with ADHD and/or ASD were eligible to participate in the program. The program required
all recruited patients to stop all their existing medications, attend weekly treatment sessions with their parents, and follow the TCM
Practitioner's dietary guidelines, during the 3-month treatment. After a rigorous screening process, 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. All participants
resided in Hong Kong.
To measure the improvement of the children's
symptoms after taking the TCM Formulae in the trial, Regencell used
SKATBT-A3 is a 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.
For example, SKATBT-A3 examines:
The effectiveness of a treatment is demonstrated
through the child's post-treatment tongue control and flexibility, the ability to focus for a longer period of time and less frequent
involuntary twitching. Regencell's formulae aim to improve blood flow to the brain and remove blood clot over time, thereby alleviating
symptoms such as inflexibility and twitching. The TCM Practitioner also believes that as the child's heart is strengthened, more
blood is delivered to the brain, resulting in an improved ability to focus.
All patients orally consumed the standardized
TCM formulae 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.
Second Efficacy Trial Results
Change in SKATBT-A3 scores
After 3 months of treatment, SKATBT-A3
scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of patients ranged between
14% and 56%, with a mean of 37%.
There were noticeable improvements in the patients'
overall health, ADHD symptoms and ASD symptoms. Common improvements include better sleep quality, reduced temper, better bowel movement
and healthier complexion. The most notable improvement were 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. This is noteworthy because limited tongue function affects verbal
communications and language abilities.
Change in VADRS scores
After 3 months of treatment, the VADRS scores
of 5 patients were lower, indicating fewer problems and improvements in symptoms, while 1 patient's score remained the same and
1 patient's score was higher. Percentage improvements of patients ranged between -21% and
62%, with a mean of 21%.
Change in ATEC scores
After 3 months of treatment, 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%.
Among the 4 subscales of ATEC, we 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. Most of the patients suffered from these symptoms before the treatment
but these symptoms improved after the treatment.
No adverse side effects
None of the patients experienced any adverse side
effects after the 3-month treatment.
Millions of children around the world are diagnosed
with ADHD and/or ASD and most of the children diagnosed with ADHD had at least one other mental, emotional or behavioral disorder. In
addition to going for behavior therapy, medications are also recommended for children who have ADHD and/or ASD. The two main types of
medication for ADHD approved by the US Food and Drug Administration ("FDA") are stimulants and non-stimulants, while the medication
for ASD are usually off-labels' and are not used in a manner specified in the FDA's approved packaging label or insert.
Such medications for ADHD and ASD usually come
with side effects such as difficulty sleeping, loss of appetite, headaches, upset stomach and mood swings, amongst others.
To address the need for a natural and holistic
treatment for such neurocognitive disorders, Regencell is in the midst of conducting further efficacy trials on its standardized TCM formulae
to corroborate the effectiveness of the TCM formulae before it is made available to people around the world.
Regencell Standardized TCM Formulae
Regencell standardized TCM formulae are natural,
orally administered liquid TCM formulae for the treatment of ADHD and ASD.
In conducting its second efficacy trial, the standardized
TCM formulae were administered to children twice daily for a period of 3 months.
Regencell standardized TCM formulae were developed
by our strategic partner TCM Practitioner based on his Sik-Kee Au TCM Brain Theory and consists
solely of natural ingredients without any synthetic components. The TCM formulae have been used for over 30 years to treat ADHD, ASD and
many other neurological illnesses, disorders and diseases and have achieved positive clinical treatment results.
brain theory explains why a healthy brain is essential in restoring the body's systems to normal. According to the TCM brain theory,
the blockage of or reduced blood flow, and damage of the interconnecting central nervous system, endocrine system and blood circulatory
system disrupt the production of hormones and transmission of neurotransmitters, such as melatonin, dopamine, and norepinephrine, leading
to a defective encoding and decoding of functions, and resulting in deficient or abnormal social behaviors that are the hallmarks of ADHD
Regencell Bioscience Holdings Limited
Bioscience Holdings Limited is an early-stage bioscience company that focuses on the research, development and commercialization of TCM
for the treatment of neurocognitive disorders and degenerations, specifically ADHD and ASD, and infectious diseases affecting people's
immune system such as COVID-19. Regencell has completed its first research study using personalized TCM formulae for the treatment of
ADHD and ASD in Hong Kong and aims to launch three liquid-based standardized TCM formulae candidates for mild, moderate and severe ADHD
and ASD patients initially in Hong Kong and subsequently in other markets as it deems appropriate. The Company has formed a joint venture
to offer COVID-19 related treatments to patients in ASEAN countries, India, Japan, Australia and New Zealand. For more information, please
visit www.regencellbioscience.com and www.regencellasia.com.
Forward-looking Statements
This press release contains "forward-looking
statements" within the meaning of applicable laws, including U.S. federal securities laws. These forward-looking statements may
include, but are not limited to, statements relating to our objectives, plans, and strategies; statements that contain projections of