RGC: Second investigational study of RGC-COV19™ replicates results of earlier trial in eliminating COVID-19 symptoms.

By Beth Senko, CFA

NASDAQ:RGC

Founded in 2014, Hong Kong-based Regencell Bioscience RGC is an early clinical stage bioscience company using Traditional Chinese Medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases such as the coronavirus disease (COVID-19).

In March 2020, Regencell's strategic partner and TCM practitioner, Mr. Sik-Kee Au, modified his proprietary cold and flu TCM formula for use in COVID-19 patients. The TCM practitioner subsequently treated 9 voluntary COVID-19 patients in the United States and patients showed improvements after an average of five days. Based on these promising results, Regencell formed a joint venture with Honor Epic Enterprises Limited in September 2021 to conduct further tests and commercialize Regencell's COVID-19 treatment in ASEAN countries.

EARTH Efficacy Trials (EARTH-A Trial and EARTH-B Trial)

From March 2020 to August 2021, Regencell set up protocols and procedures to conduct the Evaluation and Assessment of RGC-COV19^TM TCM through a Holistic approach (EARTH) efficacy trial in Malaysia and the United States. The first EARTH efficacy trial (EARTH-A Trial), was a non-blinded trial of 37 subjects to study the efficacy of Regencell's TCM formula for COVID-19 (RCG-COV19^TM) over a six-day treatment period. In the EARTH-A Trial, of the 37 subjects, 36 patients (97.3%) had all mild-to-moderate symptoms eliminated (except for Sensory Dysfunction or occasional cough) within six days.

An additional efficacy trial (EARTH-B Trial) was conducted from January 30 to March 31, 2022 to corroborate EARTH-A's results. The EARTH-B Trial followed the same design as the EARTH-A Trial, on a larger group of subjects. During the EARTH-B Trial, the Omicron variant accounted for 80% of COVID-19 cases in Malaysia. The EARTH-A Trial was conducted when Delta was the dominant variant.

51 subjects in Malaysia, aged 11 to 75, were enrolled for the EARTH-B Trial. They were of different races, ethnicity and socioeconomic background. All subjects showed onset of symptoms within five days of treatment initiation and laboratory-confirmed diagnosis of COVID-19 within three days to the start of treatment. Subjects with a confirmed diagnosis of COVID-19 but who were asymptomatic, were excluded from the study.

In the EARTH-B Trial, 50 subjects were fully-vaccinated and the one unvaccinated subject was 11 years old. Subjects who were vaccinated either received Pfizer-BioNTech, AstraZeneca or Sinovac-CoronaVac, the top three vaccines distributed in Malaysia.

Each subject was first given two doses of Regencell's formula (two days of treatment) and were followed for a maximum of six days. Subjects took a reverse transcription-polymerase chain reaction test (RT-PCR test) for COVID-19 every two days. The COVID-19 treatment ended upon patients receiving a negative RT-PCR test or when their symptoms were gone (except for loss or reduce of sense of smell and/or taste (Sensory Dysfunction) or occasional cough), at the end of the six-day study period.

To assess the efficacy and time to symptom improvement/resolution, patients recorded their symptoms daily on a three-point scale ranging from mild to severe. Patients were asked to log specific symptoms such as fever (including hot flashes or chills), upper respiratory issues (cough, sore throat, runny nose), lower respiratory issues (shortness of breath, chest pain or pressure), muscle aches, nausea, abdominal discomfort, and drowsiness, and to identify any other symptoms they were experiencing. The largest number of different symptoms reported by the enrolled patients was 16 and the average number of different symptoms reported was approximately 7.

None of the trial subjects was hospitalized and there was no death. The efficacy of RGC-COV19^TM was not affected by timing of symptom onset or underlying risk factor. Results were consistent across all ages, gender, races and ethnicity demographic among subjects.

Symptoms elimination

Of the 51 subjects, 48 patients (94.1%) had all mild-to-moderate symptoms eliminated (except for Sensory Dysfunction or occasional cough) within six days. 46 of 51 patients (90.2%) reported elimination of one or more symptoms after one day of treatment, which is considerably better than the 83.8% response reported in the EARTH-A Trial. On average, subject reported elimination of all symptoms (except Sensory Dysfunction and occasional cough) 3.6 days after starting treatment.

Clearing the virus - negative RT-PCR test

Subjects took RT-PCR tests every other day during the study. In Malaysia, the threshold for ‘not detected' is above 40, meaning a CT value of 40 or lesser means a person is COVID-19 positive while a CT value of more than 40 means a person tested negative for COVID-19. Of the 51 subjects in the study, 23.5% (n=12) tested negative for COVID-19 by the end of the study. The remaining 36 subjects who reported all symptoms eliminated (excluding Sensory Dysfunction and/or occasional cough) before the end of the study (averaging recovery period of 3.4 days) were not further tested for COVID-19.

Sensory dysfunction and breathing difficulty

Sensory dysfunction (loss or reduce of sense of smell or taste) appears to linger beyond the six-day study period for many subjects. Prior to receiving treatment, 17 of 51 subjects reported sensory dysfunction. 11 of the subjects regained their sense of smell and/or taste at the end of the six-day study, while the other six reported improvement.

Prior to treatment, 15 patients reported experiencing a combination of dyspnea (difficulty in breathing) and persistent chest pain. 10 of these 15 patients no longer experienced difficulty in breathing and/or persistent chest pain after 1 full dose of RGC-COV19^TM.

Regencell's COVID-19 formula

RGC-COV19^TM is a natural formula designed by the TCM Practitioner according to the TCM Practitioner's brain theory known as "Sik-Kee Au TCM Brain Theory^®".

According to the brain theory, brain functions depend on oxygen level required for the brain to perform normal cognitive functions. For optimal brain performance, the heart needs to function normally to deliver sufficient oxygen to the brain. When the heart is weakened, the heart's ability to deliver enough blood to circulate oxygen throughout the body is impaired. When this happens, brain functions are suppressed, resulting in a person experiencing fatigue, nausea, disorientation and reduced immune response.

RGC-COV19^TM is designed by the TCM Practitioner to strengthen the heart's functions. According to the brain theory, when the heart is strengthened, it increases blood flow and delivers more oxygen to the brain, resulting in reduced blood clots and restored brain functions.

Regardless of the COVID-19 variant, the lungs and heart are where the coronavirus does much of its damage, and such infection can set off an inflammatory immune response that ravages infected and uninfected cells alike, leading to tissue scarring and oxygen deprivation which will in turn reduce optimal brain function. RGC-COV19^TM is a natural formula designed by the TCM Practitioner according to the TCM Practitioner's brain theory known as "Sik-Kee Au TCM Brain Theory®".

RGC-COV19^TM has been formulated to generate more responsive cognitive function which in turn, stimulates the body's own healing mechanism to reduce COVID-19 symptoms. RGC's formula and the body's own response work together to:

• reduce and clear the mucus and phlegm from the upper respiratory system;

• dispel exterior viral pathogen via heavy sweats, urine and excrement;

• clear endogenous and liver heat;

• detox the liver, and

• improve circulation.

Upcoming results in follow-on study of ASD/ADHD treatment formula

Regencell Bioscience is expected to report results of a follow-on study for its ASD/ADHD treatment. Currently, the Company is working towards the production of an effective standardized formula for commercialization purposes.

The formula is based on the "Sik-Kee Au TCM Brain Theory®" that ASD and ADHD stem from inadequate blood flow and creation of neurotransmitters in the developing brain. As we discussed earlier, this hypothesis is complementary to the western medicine view that ASD and ADHD are present at birth and arise from developmental differences in brain function.

Regencell Bioscience's first clinical trial was designed to establish benchmarks for treatment, dosing, adverse effects (AEs) and measuring patients' response in a systematic and repeatable way, while evaluating the effectiveness of a customized TCM formula.

As a customized formula is designed to suit each patient's symptoms, the ability for it to be produced in large quantities is limited as compared to a standardized formula. Regencell is currently evaluating and assessing the effectiveness of a standardized TCM formula in reducing ADHD and ASD symptoms in children through a holistic approach within 3 months of treatment, in its second efficacy trial.

Path to registration and commercialization

Regencell Bioscience has a four-year timeframe to commercialize its standardized formulations and gain proprietary Chinese medicine (pCm) registration in Hong Kong. The Company has a number of tasks ahead:

• Completing its second clinical trial for ASD/ADHD and COVID, and evaluating results.

• Conducting additional clinical trials to support its proprietary formulae in ASD/ADHD and other applications.

• Obtaining patents and other forms of IP protection in Hong Kong and other markets.

• Establishing manufacturing capability and supply chain that will meet registration requirements.

• Assembling and filing documentation for pCm approval.

• Build out its marketing and distribution strategy and infrastructure.

We believe that an emphasis on conducting well-designed clinical trials that measure outcomes based on well-established assessment instruments, will provide Regencell Bioscience with a competitive advantage in terms of expertise and credibility in an industry that is moving towards higher standards for efficacy, safety and quality. While there is still much work to do, in our view, Regencell Bioscience is taking a thoughtful, systematic approach to developing its TCM formulae.

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