Full Press Release Details
Regencell Bioscience's
Investigational Liquid-Formula RGC-COV19TM Shows Effectiveness Through Its Enrolled Patients in Eliminating Mild to Moderate
COVID-19 Symptoms within the 6-day Treatment Period in its EARTH Efficacy Trial
Hong Kong, February 17, 2022 - Regencell Bioscience
Holdings Limited (NASDAQ: RGC) ("Regencell" or the "Company") today announced the results from an
analysis of a total of 37 individuals enrolled in its Evaluation and Assessment of RGC-COV19TM
TCM through a Holistic approach ("EARTH") efficacy trial conducted by Regencell Bioscience
Asia Limited ("Regencell Asia") of its novel COVID-19 oral TCM candidate RGC-COV19TM (Regencell Bioscience
(RGCA-CV01) liquid formulation). The results have yet to be peer reviewed. Upon successful completion of the EARTH efficacy trial, RGC-COV19TM
could be used more broadly for the treatment of the population who seek a natural and holistic approach to effectively reduce and eliminate
COVID-19 symptoms and to reduce the risk of hospitalization and death.
"The results of EARTH mark an important
journey for the Company in its goal to save and improve lives of patients all around the world. As COVID-19 cases continue to rise globally
in 2022, there is an urgency to find a holistic approach towards treating COVID-19. By establishing Regencell Asia and through EARTH's
preliminary findings, we hope the process of finding an alternative, natural treatment for COVID-19 will be accelerated. These results
highlight the potential of offering a natural and holistic treatment for COVID-19," said Ji Yang Lee (Jay), Chief Executive Officer
and Co-Founder of Regencell Asia.
About EARTH Efficacy Trial
The primary objective of EARTH is to evaluate
and assess the efficacy of Regencell Bioscience's TCM - RGC-COV19TM (Regencell Bioscience (RGCA-CV01) liquid formulation)
in reducing and eliminating COVID-19 symptoms through a holistic approach within a 6-day period.
EARTH was a non-blinded efficacy trial conducted
from 1 October 2021 until 31 January 2022. The eligibility criteria required that all patients had laboratory confirmation of SARS-CoV-2
infection within 3 days prior to treatment and with symptoms onset within 5 days prior to treatment.
Based on the above-mentioned criteria, patients
who were asymptomatic were rejected and 37 random individuals eventually qualified for enrolment and were enrolled. The enrolled patients
were between the ages of 5 to 61 and of different races, ethnic backgrounds and socioeconomic backgrounds. 23 individuals were based in
Kuala Lumpur and Seremban, Malaysia while the other 14 individuals were based in California, the United States. 23 out of the 37 enrolled
patients started taking RGC-COV19TM within 3 days of symptoms onset and the remaining 14 patients started taking RGC-COV19TM
between 4 to 5 days of symptoms onset.
In conducting EARTH, Regencell Asia set a maximum
of 6 days of treatment per patient. Enrolled patients were required to report their COVID-19 symptoms every day according to 3 severity
categories (mild, moderate, severe) and the list contained symptoms such as fever, fatigue, cough, sore throat, runny nose, headache,
nausea, feeling hot, chills, drowsy, shortness of breath, persistent chest pain or pressure, muscle ache and abdominal discomfort. Patients
were also requested to identify any other symptoms that they were experiencing. Each patient received 2 days of treatment progressively
while a reverse transcription polymerase chain reaction (RT-PCR) test for patients in Malaysia was conducted every 2 days.
Whenever a patient's RT-PCR test result
turned negative or patients no longer had any COVID-19 symptoms (save for Sensory Dysfunction or occasional cough) within the 6-day treatment
period, the treatment ended. While receiving the TCM treatment, 3 of them were not vaccinated, 3 were partially vaccinated and 31 were
fully vaccinated. At the end of the treatment, the total number of patients whose symptoms were completely eliminated within the 6-day
treatment period, save for Sensory Dysfunction and occasional cough, were recorded to determine the efficacy.
About EARTH's Results
Efficacy of complete symptoms elimination within
the 6-day treatment period
Out of the 37 COVID-19 patients, 36 patients had
all symptoms eliminated, save for Sensory Dysfunction and occasional cough, within the 6-day treatment period. Our efficacy trial showed
that after taking RGC-COV19TM, 97.3% of the patients had their mild to moderate COVID-19 symptoms eliminated, save for Sensory
Dysfunction and occasional cough, within the 6-day treatment period. 15 out of the 36 patients experienced Sensory Dysfunction prior to
receiving treatment. Among those 15 patients, 5 recovered their sensory functions while the remaining 10 showed improvements at the end
of the 6-day treatment period.
Out of the 36 patients, the number of days it
took for all symptoms to be eliminated, save for Sensory Dysfunction and occasional cough, within the 6-day treatment period, was 1 day
= 6 patients, 2 days = 7 patients, 3 days = 5 patients, 4 days = 11 patients, 5 days = 4 patients, and 6 days = 3 patients.
Symptoms elimination after 1 full dose of RGC-COV19TM
31 out of 37 COVID-19 patients, representing approximately
83.8% of patients, reported the elimination of one or more symptoms after taking 1 full dose of RGC-COV19TM, with the largest
number of symptoms eliminated after 1 day of treatment reported by a patient being 7. The average number of days it took from the start
of treatment for all 37 COVID-19 patients to eliminate all symptoms, save for Sensory Dysfunction and occasional cough, was approximately
3.4 days. The largest number of different symptoms reported by patients was 14 and the average number of different symptoms reported was
Malaysia - treatment leading to negative
Out of the 23 patients from Malaysia, 10 patients
(representing approximately 43.48%) tested negative RT-PCR within the 6 days treatment (Negative RT-PCR in 2 days = 4 patients, 4 days
= 4 patients, 5 days = 1 patient, 6 days = 1 patient). Since the start of the treatment, the average days taken for these 10 patients
to test negative is 3.5 days. The minimum and maximum days taken for patients to test negative was 2 and 6 days, respectively. The remaining
13 patients had all symptoms eliminated, save for Sensory Dysfunction and occasional cough, within 6 days (average approximately 3.5 days)
and therefore was not further tested for COVID-19.
Taking the treatment within 3 days from symptoms
onset vs within 4 to 5 days from symptoms onset
Further analysis showed that the 23 patients who
started taking RGC-COV19TM within 3 days from symptoms onset took an average of approximately 3.2 days for the elimination
of all symptoms, save for Sensory Dysfunction and occasional cough, whereby the maximum number of different symptoms reported by any one
individual was 14 and the average number of different symptoms reported was 5.
The remaining 14 patients who started taking RGC-COV19TM
between 4 to 5 days from symptoms onset took an average of approximately 3.6 days for the elimination of all symptoms, save for Sensory
Dysfunction and occasional cough, whereby the maximum number of different symptoms reported by any one individual was 13 and the average
number of symptoms reported was 7.
The 3 patients who were not vaccinated reported
an average of 3 symptoms each and all 3 patients took an average of approximately 2.3 days for symptoms to be eliminated. The 3 patients
who were partially vaccinated reported an average of 3 symptoms each and took an average of approximately 3.3 days for all symptoms to
be eliminated, save for Sensory Dysfunction. 1 of these 3 patients tested negative RT-PCR after 4 days of treatment. The remaining patients
who were fully vaccinated reported an average number of 6 symptoms each and these patients took an average of approximately 3.5 days for
all symptoms to be eliminated, save for Sensory Dysfunction and occasional cough. All patients who were vaccinated either received a single
dose, double dose, or a combination of vaccine from Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac-CoronaVac and/or Johnson & Johnson's
Out of the 37 patients, 9 patients experienced
a combination of dyspnea (difficulty breathing) and persistent chest pain. 6 of these 9 patients no longer experienced difficulty breathing
and/or persistent chest pain after 1 full dose of RGC-COV19TM.
No adverse side effects
Based on the patients' self-reported data,
there were no worsening of symptoms during and after consuming RGC-COV19TM and none of the patients experienced any unknown
adverse side effects.
No treatment emergent adverse events
Among the 3 patients with comorbidities such as
systemic lupus erythematosus (SLE), asthma and cancer, there were no treatment emergent adverse events and no discontinuation of RGC-COV19TM
due to adverse results.
Death/Hospitalization
At the end of the EARTH efficacy trial, none of
the patients was hospitalized and there was no death. The efficacy of RGC-COV19TM was not affected by timing of symptom onset
or underlying risk factor. Results were consistent across all ages, gender, races and ethnicity demographic among the enrolled patients.
There are hundreds of millions of individuals
who have been diagnosed with COVID-19 around the world, and some experience post-COVID symptoms such as extreme tiredness (fatigue), shortness