TrialSite News followed the experimental use of Ivermectin starting with the Monash University cell culture study revealing that the anti-parasitic zaps SARS-CoV-2 in vitro—reducing it by about 5,000 times in 48 hour. We later identified that a French biotechnology company called MedinCell, which happened to be studying Ivermectin in the context of malaria, quickly pounded on both the data and the fact that it was already working with the anti-parasitic drug to commence a study on humans with COVID-19. Recently, MedinCell was in the news again.
TrialSite News was intrigued with MedinCell as they may actually have been the first group to embrace the use of Ivermectin as an investigational drug targeting SARS-CoV-2 in humans. Digital news site Born2Invest writer Angelique Moss recently visited the topic of MedinCell. Ms. Moss reported that Christophe Douat, CEO of the company detailed their ivermectin strategy. They were already conducting studies centering on malaria. But the Monash University findings stimulated their interest to invest in a clinical study.
The First to Declare an Ivermectin Program for COVID-19?
Hence, the French biotech company has embarked on a clinical trials initiative, announcing this initiative on April 6, 2020. The company referenced the Monash University study and commented, “MedinCell has published data showing that long-acting formulations of Ivermectin can be designed with varying doses and durations with its BEPO® technology and is already leading a program aiming at developing a 3-month injectable product to fight malaria.”
MedinCell BEPO® Technology
BEPO®, the company touts, is a simple and flexible technology based on proprietary copolymers and a biocompatible solvent (where the API is solubilized or suspended), and forms a fully bioresorbable depot once injected. In this way, according to their website, the technology ensures a regular delivery of a drug at the optimal dose for periods of time—e.g. several days, week or even months commencing from the “subcutaneous or local injection of simple deposit of a few millimeters, fully bioresorbable BEPO can be administered subcutaneously for systematic exposure of APIs or locally for targeted treatments.”
The Study: Combine Ivermectin and BEPO
In investor announcements the company highlighted the need for clinical trials to “confirm the action of Ivermectin on the COVID-19 virus, and the potential effectiveness of a long-acting injectable on its prevention and therefore breaking the chain of transmission.” MedinCell positions that should the study demonstrate positive results, the company positions itself to offer a “BEPO® technology based long-acting injectable Ivermectin” which would be “a rapidly deployable and affordable solution for the global pandemic.”
The MedinCell approach would potentially facilitate compliance as there would be no tablets involved but rather an intravenous delivery of the drug. CEO Douat in envisioning positive results would consider a preventive phase, noting, “Compared to treatment in tablet form, the development of long-acting injectable form would have added value over a preventive treatment lasting several months.”
MedinCell often partners with non-governmental organizations (NGOs) such as Unitaid and the Bill & Melinda Gates Foundation. For example, they recently received $6.4 million from Unitaid. In this arrangement, reports Ms. Moss the company develops the targeted drug using the funding from the NGOs and “cedes marketing rights for low-and middle-income countries.” The company will internally fund the Ivermectin clinical trials program.
Who is MedinCell?
Medincell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, Medincell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing over 25 different nationalities.
Some Company Highlights
First and foremost, they position that they have advanced an investigational product to Phase III while securing financing through NGOs and partnerships such as the Bill & Melinda Gates Foundation, according to a recent investor presentation. Their Phase III target involves a partnership with Teva. Known as mdc-IRM, the sponsors have been conducting this multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of risperidone extended-release suspension for subcutaneous use as a maintenance treatment in adult and adolescent patients with schizophrenia.