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Regencell Bioscience Posts Additional EARTH Efficacy Trial Results Corroborating Effectiveness of its Investigational Liquid-Formula RGC-COV19 in Eliminating Mild to Moderate COVID-19 Symptoms within the 6-Day Treatment Period
19 May 2022 - - Hong Kong-based bioscience company Regencell Bioscience Holdings Ltd. (NASDAQ: RGC) has posted results from an analysis of a total of 51 individuals enrolled in its additional Evaluation and Assessment of RGC-COV19 TCM through a Holistic approach efficacy trial conducted by Regencell Bioscience Asia Ltd. of its novel COVID-19 oral TCM candidate RGC-COV19 (Regencell Bioscience (RGCA-CV01) liquid formulation), the company said.

These results are consistent with the earlier analysis announced in February 2022, showing RGC-COV19 is effective in reducing and eliminating COVID-19 symptoms within six days, which in turn reduces the risk of hospitalization and death.

The results have yet to be peer-reviewed.

The primary objective of EARTH is to evaluate and assess the efficacy of Regencell's TCM RGC-COV19 (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 prior to treatment.

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-COV19 within 3 days of symptoms onset and the remaining 3 patients started taking RGC-COV19 between 4 to 5 days of symptoms onset.

Regencell Asia set a maximum of six days of treatment per patient. Enrolled patients were required to report their COVID-19 symptoms every day according to three 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 two 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.

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-COV19 in eliminating COVID-19 symptoms within six 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 six-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.

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-COV19.

Based on the patients' self-reported data, there were no worsening of symptoms during and after consuming RGC-COV19 and none of the patients experienced any unknown adverse side effects.

Regencell Bioscience Holdings Ltd is a bioscience company that focuses on research, development and commercialization of traditional Chinese medicine (TCM) for the treatment of neurocognitive disorders and degeneration, specifically attention deficit and hyperactivity disorder (ADHD) and autism spectrum disorder (ASD).

Since its listing, Regencell through a joint venture with Honor Epic Enterprises Ltd., formed Regencell Bioscience Asia Ltd. to offer COVID-19 related treatments to patients in ASEAN countries, India, Japan, Australia and New Zealand, as Regencell aspires to be the global market leader for the provision of natural and holistic treatment for neurological disorders and infectious diseases.


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