- The Sik-Kee Au TCM Brain Theory® Assessment for ADHD and
ASD (“SKATBT-A3”), which measures the effectiveness
of the treatment on the patient’s overall body and
neurodevelopmental conditions, showed a mean percentage improvement
of 37% in the second efficacy trial based on the scoring system of
SKATBT-A3.
- The first efficacy trial using personalized TCM formulae
have shown a mean percentage improvement of 30% in ADHD symptoms
and a mean percentage improvement of 37% in ASD symptoms, based on
the scoring systems under the Vanderbilt ADHD Diagnostic Parent
Rating Scale (“VADRS”) and the Autism Treatment Evaluation
Checklist (“ATEC”), respectively, after 3 months of
treatment.
- The ongoing second efficacy trial using standardized TCM
formulae have shown a mean percentage improvement of 21% in ADHD
symptoms and a mean percentage improvement of 22% in ASD symptoms,
based on the scoring systems under VADRS and ATEC respectively,
after 3 months of treatment.
Regencell Bioscience Holdings Limited (Nasdaq: RGC)
(“Regencell”) today announced its interim results from its
second efficacy trial.
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, an assessment developed by Regencell based on
patients’ overall body and neurodevelopmental conditions;
- VADRS, an ADHD assessment; and
- ATEC, an ASD assessment.
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 flexibility of the child’s tongue (e.g., prior to
treatment, the child may be unable to extend his tongue and had to
use his own fingers to pull and stretch his tongue);
- the child’s willingness and proactiveness to participate in
social gatherings and to learn (e.g., the child’s ability to focus
and engage in school work); and
- involuntary twitching.
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.
An Unmet Need
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.
The TCM 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 and ASD.
Regencell Bioscience Holdings Limited
Regencell 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 results of
operations or of financial condition; statements relating to the
research, development, and use of our platform technologies,
technologies, products and product candidates; and all statements
that address activities, events, or developments that we intend,
expect, project, believe, or anticipate will or may occur in the
future. The risks and uncertainties of our company include: our
ability to obtain regulatory approval and ultimately commercialize
our TCM formulae and/or products based on our TCM formulae; the
outcome of our research study free from biases of parents or
caregivers of patients because we relied on the data provided by
them; difficulties enrolling patients in our research studies; any
undesirable side effects caused by the TCM formulae candidates
which could delay or prevent their regulatory approval or hinder
commercialization; whether results of our earlier studies on
personalized TCM formulae can be predictive of future research
study results; failure of the research and development process;
whether any TCM formulae candidates can be developed, manufactured,
sold, marketed and distributed; the ability to successfully
commercialize any future therapeutics; our ability to enhance our
brand recognition; our ability to obtain and protect our
intellectual property; and any adverse publicity associated with
our TCM formulae candidates, ingredients or network marketing
programs. We have based these forward‐looking statements on
assumptions and assessments made by our management in light of
their experience and their perception of historical trends, current
conditions, expected future developments, and other factors they
believe to be appropriate. We have also relied upon and assumed,
without independent verification, the accuracy and completeness of
all information available from public sources and makes no express
or implied warranty as to the accuracy or completeness of any such
information. Even if our results of operations, financial condition
and liquidity, and the development of the industry in which we
operate are consistent with the forward-looking statements
contained in this presentation, they may not be indicative of
results or developments in future periods. For a discussion of
these and other risks and uncertainties, see our Annual Report on
Form 20-F for the year ended June 30, 2021, which is available on
the SEC’s website at www.sec.gov. All information in this press
release is as of the date of the release, and we undertake no duty
to update this information unless required by law. This caution is
made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220912005506/en/
Investor Relations James Chung ir@rgcbio.com +852 2155 0823
Regencell Bioscience (NASDAQ:RGC)
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