Full Press Release Details
Regencell Bioscience Announces Additional EARTH
Efficacy Trial Results Corroborating Effectiveness of its Investigational Liquid-Formula RGC-COV19TM in Eliminating Mild to
Moderate COVID-19 Symptoms within the 6-Day Treatment Period
Results of EARTH efficacy trial
| EARTH Efficacy Trials | ||||||
| Period of trial | 30 January 2022 - 31 March 2022 (EARTH-B Trial) | 1 October 2021 - 31 January 2022 (EARTH-A Trial) | 1 October 2021 - 31 March 2022 (EARTH-A and EARTH-B Trials, combined) | |||
| Number of patients | 51 | 37 | 88 | |||
| Complete symptoms elimination in 6 days (% of patients) | 94.1 | 97.3 | 95.5 | |||
| Elimination of one or more symptoms after 1 full dose of RGC-COV19 TM (% of patients) | 90.2 | 83.8 | 87.5 | |||
| Testing negative in 6 days (% of patients) | 23.5 | 43.5 | 29.7 | |||
| Recovery period for patients who took RGC-COV19 TM within 3 days of symptoms onset (days) | 3.7 | 3.2 | 3.5 | |||
| Recovery period for patients who took RGC-COV19 TM between 4-5 days of symptoms onset (days) | 2.3 | 3.6 | 3.4 | |||
| No longer experienced difficulty breathing and/or persistent chest pain after 1 full dose of RGC-COV19 TM (% of patients) | 57.1 | 66.7 | 66.7 |
Hong Kong, May 18, 2022 - Regencell Bioscience
Holdings Limited (NASDAQ: RGC) ("Regencell" or the "Company") today announced the results from an
analysis of a total of 51 individuals enrolled in its additional Evaluation and Assessment of RGC-COV19TM
TCM through a Holistic approach efficacy trial (the "EARTH-B 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). These results are consistent with the earlier analysis announced in February 2022 (the "EARTH-A
Trial"), showing RGC-COV19TM is effective in reducing and eliminating COVID-19 symptoms within 6 days, which in turn
reduces the risk of hospitalization and death. The results have yet to be peer-reviewed.
"Regencell is committed to delivering alternative
treatments that are safe and effective through the use of Traditional Chinese Medicine ("TCM"). Rigorous trials have
been conducted and results have shown noticeable improvement in COVID-19 symptoms among our trial participants following the administration
of RGC-COV19TM. Following the EARTH-B Trial's results corroborating the effectiveness of RGC-COV19TM, we believe
RGC-COV19TM can be a potential treatment that helps rehabilitate COVID-19 patients," said Ji Yang Lee (Jay), CEO of Regencell
While emerging new COVID-19 variants continue
to remain a threat to the public health, Regencell will continue to work in tandem with its R&D units to develop new breakthroughs
designed to transform the way COVID-19 is being managed globally and provide safe and effective treatment for everyone.
The primary objective of EARTH is to evaluate
and assess the efficacy of Regencell'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.
The EARTH B Trial was conducted in Malaysia from
30 January 2022 until 31 March 2022, when Omicron represented 80% of the COVID-19 cases in Malaysia since 10 January 2022, replacing Delta
as the dominant COVID-19 strain. The eligibility criteria for enrolment remained the same as the earlier efficacy trial, requiring all
patients to have laboratory confirmation of SARS-CoV-2 infection within 3 days prior to treatment and with symptoms onset within 5 days
Based on the above-mentioned criteria, patients
who were asymptomatic were rejected and a larger cohort of 51 random individuals qualified and were enrolled for the EARTH-B Trial, as
compared to 37 random individuals in EARTH-A Trial. The enrolled patients were between the ages of 11 to 75 and of different races, ethnic
backgrounds and socioeconomic backgrounds. All 51 individuals were based in Kuala Lumpur, Malaysia. 48 out of the 51 enrolled patients
started taking RGC-COV19TM within 3 days of symptoms onset and the remaining 3 patients started taking RGC-COV19TM
between 4 to 5 days of symptoms onset.
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
and 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 asked to identify
any other symptoms they were experiencing. Each patient received 2 days of treatment progressively while a reverse transcription polymerase
chain reaction (RT-PCR) test 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, 50 individuals were fully vaccinated and 1 child below 12 years old was
not 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 the EARTH-B Trial's Results
Efficacy of complete symptoms elimination within
the 6-day treatment period
Results from this analysis of 51 trial participants
build upon and corroborate previously released data and demonstrate the effectiveness of RGC-COV19TM in eliminating COVID-19
symptoms within 6 days.
Of the 51 patients, 48 patients (representing
94.1% of the patients) had all their mild to moderate COVID-19 symptoms eliminated, save for Sensory Dysfunction and occasional cough,
within the 6-day treatment period. 17 out of the 51 patients experienced Sensory Dysfunction and among those 17 patients, 11 recovered
their sensory functions while the remaining 6 showed improvements at the end of the 6-day treatment period.
Out of the 48 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
= 3 patients, 2 days = 14 patients, 3 days = 9 patients, 4 days = 13 patients, 5 days = 4 patients, and 6 days = 5 patients.
Symptoms elimination after 1 full dose of RGC-COV19TM
In this analysis, a higher percentage of COVID-19
patients (90.2% compared to the previous efficacy trial of 83.8%), 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 8.
The average number of days it took from the start of treatment for all 51 patients to eliminate all symptoms, save for Sensory Dysfunction
and occasional cough, was approximately 3.6 days. The largest number of different symptoms reported by patients was 16 and the average
number of different symptoms reported was approximately 7.
Treatment leading to negative RT-PCR
12 patients (representing approximately 23.5%)
tested negative RT-PCR within the 6 days treatment (Negative RT-PCR in 2 days = 6 patients, 4 days = 6 patients). Since the start of the
treatment, the average days taken for these 12 patients to test negative were 3 days. The minimum and maximum days taken for patients
to test negative were 2 and 4 days, respectively. 36 patients had all symptoms eliminated, save for Sensory Dysfunction and occasional
cough, within 6 days (average approximately 3.4 days) and therefore was not further tested to obtain a negative RT-PCR result.
Taking the treatment within 3 days from symptoms
onset vs within 4 to 5 days from symptoms onset
The recent analysis showed that 48 out of the
51 patients started taking RGC-COV19TM within 3 days from symptoms onset and they took an average of approximately 3.7 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 16 and the average number of different symptoms reported was 8.
The remaining 3 patients who started taking RGC-COV19TM
between 4 to 5 days from symptoms onset took an average of approximately 2.3 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 8 and the average
number of symptoms reported was 5.
50 individuals were fully vaccinated and 1 child
below 12 years old was not vaccinated. All 12 patients who tested negative RT-PCR in 4 days were fully vaccinated prior to taking the
RGC-COV19TM treatment. All patients who were vaccinated received vaccine from either Pfizer-BioNTech, AstraZeneca or Sinovac-CoronaVac,
which are the top 3 vaccines distributed in Malaysia.
Out of the 51 patients, 15 patients experienced
a combination of dyspnea (difficulty breathing) and/or persistent chest pain. 10 of these 15 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 patients with chronic conditions such
as chronic migraine, eczema, asthma, thyroid disease, high blood pressure and high cholesterol, 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-B 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 factors. Results were consistent across all ages, gender, races and ethnicity demographic among the enrolled patients.