By Charles Coles
According to the Clinical Trials website there are seven drug trials related to Covid-19 in New Zealand. One has been completed, a new one is about to start as recruitment is underway, and five are still active.
Now, what follows is a lot of scientific stuff that we at The Buzz do not understand and can’t interpret. So we publish it here in good faith…
1) The completed trial – held in Christchurch and sponsored by Akesobio Australia Pty Ltd – was to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73 (something to do with cancer).
The pre-clinical trial blurb states: “The study consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.”
A statement by the company says: “As a full antagonist of CD73 activity, AK119 completely blocks CD73 activity, causes B cell activation and enhances antibody production.
“Enhanced antibody production in Novel Coronavirus (‘‘COVID-19’’) patients may potentially augment their ability to destroy SARS- CoV-2 virus. Therefore, AK119 could potentially be the effective treatment to be used for COVID-19 illness. AK119 may also result in stronger immunity to SARS-CoV-2 virus, and potentially be used in conjunction with vaccination of healthy people to enhance the efficacy of vaccines.”
In the double-blind study, 80 per cent of trial participants would receive two doses of ReCOV and the rest would be given a placebo containing no active medication. The vaccines already given to the Auckland volunteers contained low doses, with higher doses to be administered after the initial trials were reviewed.
The firm says: “PBI-0451 works by inhibiting Viral Main Protease (Mpro), a highly conserved key protein in the virus required for its replication, thus blocking the virus’ ability to replicate.
“The highly conserved nature of Mpro across multiple coronaviruses, including emerging variants of concern such as Delta and Lambda, supports the potential for PBI-0451 to target both existing and future coronaviruses. In preclinical studies, PBI-0451 has been shown to inhibit replication of a broad range of coronaviruses including SARS-CoV-2 across multiple in-vitro models, and was well tolerated in clinically enabling toxicity studies.”
The company says in a press release that: “The USSF/Vaxform CoV-OGEN1 vaccine presented serum antibodies specific to SARS-CoV-2 in mammals ingesting the vaccine within 2 days after consumption.
“This data gives USSF great confidence the oral vaccine allows recipients to present antibodies in the mucosal (mouth, nose and throat) systems as well as blood sera (conventional vaccine).
“These results, combined with other pre-clinical data, support our decision to continue to ramp-up production to provide this much needed oral vaccine to global markets. Much of the world still needs safe and effective shelf-stable vaccines that are not dependent upon administration by trained medical staff.”
The company says: “Both poliovirus and coronavirus are positive-strand RNA viruses and they may induce and be affected by common innate immunity mechanisms. Recent reports indicate that COVID-19 may result in suppressed innate immune responses.
“Early clinical studies showed that oral polio vaccine (OPV) protected against poliomyelitis, in addition to reducing the number of other viruses that could be isolated from immunized children, compared with placebo recipients.
“Large-scale clinical studies of OPV for non-specific prevention of diseases were carried out in the 1960s and 1970s. These involved more than 60,000 individuals and showed that OPV was effective against influenza virus infection, reducing morbidity 3.8-fold on average.
“SARS-CoV-2 viruses (Covid-19) can directly invade the nervous system of patients, instead of injuring the nervous system through the immune response. It was observed that patients surviving Covid-19 are at high risk for subsequent development of neurological disease and in particular Alzheimer’s disease.”
6) MJM Bonten (unable to locate this company’s website), with assistance from the Australian and New Zealand Intensive Care Research Centre, Medical Research Institute of New Zealand, and others, is performing a randomised trial of REMAP-CAP for community-acquired pneumonia.
It’s drug trial page states: “Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body.
“When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don’t always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.
“This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren’t able to do that.
“The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.”
7) Out of France is Valneva which is trialing VLA2001. In a statement, the company says: “As part of the product development strategy, Valneva has completed recruitment of 306 volunteers aged 56 years and older in New Zealand into its VLA2001-304 trial and expects topline data in early 2022.
“Valneva has also announced the start of recruitment of adolescents as an expansion of the Cov-Compare trial.
“The Company is preparing for trials in children (5-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001’s booster performance for people in need of a booster.”