The FDA warned Americans to never use medications like Ivermectin that “is intended for animals.”
They called it a horse drug.
Now a clinical trial conducted by MedinCells and surprisingly funded by the Bill and Melinda Gates Foundation confirmed the safety of ivermectin taken daily in oral form.
According to the press release, there were no side effects observed with the three doses of ivermectin tested up to 100 μg/kg in continuous administration over 1 month in healthy volunteers.
MedinCell tested ivermectin taken daily in oral form to simulate the continuous release of the active substance by a long-acting injectable. After completion, the study confirms the safety of ivermectin up to a dose of 100 μg / kg / day in continuous administration over 1 month in healthy volunteers. No significant difference was observed between the treated volunteers and the placebo volunteers in the three cohorts studied successively (daily doses of 50 μg / kg, 75 μg / kg and 100 μg / kg respectively).
The pharmacokinetic data of the three cohorts shows a limited peak circulating plasma concentration in the first 12 hours (Cmax between 25-60 ng / mL) and the rapid achievement of a stationary regime and a regular plasma concentration of between approximately 10 and 30 ng / mL for 28 days, depending on the dose administered. These preliminary results are considered positive and live up to Company expectations based on the data in the literature. The dose-response relationship has not yet been established.
The study started last September 2020 and ended last March 2021. The study was titled, “Exploratory phase 1, randomized, double-blind trial assessing the pharmacokinetic profile, safety and tolerability of a regime of continuous daily administration of Ivermectin to healthy volunteers.” according to the NIH.
There were 24 applicants in total and they were divided into 3 successive cohorts of 8 healthy volunteers (one cohort per dose).
Important Inclusion Criteria:
Subject is male of any ethnic origin.
Subject is aged between 18 to 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.
Subject is ≥50 kg.
Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.
Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.
Here is the study result:
After study completion, an expert review was conducted last March 2021 by Professor Jacques Descotes, Professor Emeritus, Claude Bernard University of Lyon. Read his conclusion below:
Hundreds of millions of human subjects have been treated with ivermectin for curative or prophylactic purposes worldwide over the last 3 decades. The reference list of this report demonstrates that a large body of data is available, which allows for a detailed analysis of ivermectin medical safety. Undoubtedly, uncertainties remain regarding ivermectin pharmacological effects and mechanisms of action, but when removed, this is not anticipated to alter the main conclusions of this report in any significant way as they rely on an extensive and consistent body of medical publications.
Taking into account all the above, the author of the present analysis of the available medical data concludes that the safety profile of ivermectin has so far been excellent in the majority of treated human patients so that ivermectin human toxicity cannot be claimed to be a serious cause for concern.
Here’s the Expert Review Report:
The study about the safety of Ivermectin is only the beginning of an essential step for their ivermectin programs, in particular mdc-TTG in Covid-19, according to Joël Richard, Chief Development Officer at MedinCell.
In April 6, 2020, Medincell announced that it has launched its COVID-19 program. This program aims to develop a long-acting injectable Ivermectin formulation to protect people who are not infected with COVID-19 in order to break the virus chain of transmission.
MedinCell announced on April 6, 2020, its Covid-19 project launched a few weeks ago. This program aims at developing a long-acting injectable Ivermectin formulation for several months to protect people who are not infected with Covid-19 in order to break the virus chain of transmission. Such a tool could play a decisive role in the management of Covid-19 pandemic, by enabling many people around the world, especially those most exposed and at risk, to protect themselves.
Ivermectin has long been considered a safe and effective drug to treat some parasitic diseases. Its action on viruses such as SARS, rabies, influenza, HIV, Dengue or the West Nile has been proven in vivo or in vitro in the past, suggesting a potential against Covid-19. On March 29, 2020, researchers from Monash University in Melbourne, Australia published results from a laboratory cell study showing that Ivermectin can kill the coronavirus in less than 48 hours.
Studies have been carried out by research institutes for the past few months to assess the effectiveness of treatment using Ivermectin on hospitalized patients with Covid-19. MedinCell published last January data showing that Ivermectin can be formulated with our BEPO^® technology as a long-acting for varying doses and durations of up to several months.
The company is already developing a long-acting injectable Ivermectin formulation for several months to neutralize the malaria vector. The success of this program is conditioned in particular by the results of future in vitro, in vivo and clinical studies. The objective of these studies will be to validate the efficacy and safety of Ivermectin against Covid-19 for prophylactic (preventive) action in humans and to determine the dose required.
There is still no exact date as to when the product will be released but their goal is to release this year.
“Our hypotheses are being confirmed, says Christophe Douat, CEO of MedinCell: the pandemic continues, and vaccination may not be enough to stop it. The body of clinical data and scientific knowledge supporting the efficacy of ivermectin at a therapeutic dose against Covid-19, in particular as a prophylaxis, continues to grow. In this context, our treatment, based on a widely known molecule, which could be stored at room temperature and which aims to offer protection for several months after a simple injection against Covid-19 and its variants, could become a key tool of the anti-Covid arsenal. Our goal is still to have a product ready in 2022.”
Medincell SA is a France-based manufacturer of biological products and pharmaceutical preparations that works on both for-profit and non-profit projects, in collaboration with partners ranging from pharmaceutical corporations to physicians, from biotechnology firms to academics and foundations.
MedinCell receives a grant from the Bill & Melinda Gates Foundation last 2019 and has signed an agreement for up to an additional $19 million to be granted over four years. This is to fund preclinical activities and a phase 1 clinical trial for the injectable six-month bioresorbable contraceptive (mdc-WWM).
In August 2021, the French company received another grant from the Bill and Melinda Gates Foundation. This aim is to support the evaluation of a long-acting injectable ivermectin formulation as an endectocide for malaria control. The company expanded the program to include injectable ivermectin as COVID-19 preventative medication.
Here’s the press release about the clinical trial conducted by MedinCell which confirms the safety of continuous administration of ivermectin.