This is exciting stuff!! Medincell's BEPO tech is injected under the skin and secretes ivermectin. The goal is prophylaxis -- preventing catching covid19.

In a study using BEPO and ivermectin on cattle, one dose (if I read the study correctly) maintained ivermectin in their blood stream for a year, as shown in this chart.

They will be testing an injectable that lasts for a month, with a 3-month alternative under continuing development. They are already anticipating the process of getting regulatory approval (probably not focusing on FDA approval?) and mass production with a partner company.

The Gates Foundation is funding Medincell's tech research and the trial (at least, that's been stated previously).

An alternative to Medicell's tech, of course, is simply taking ivermectin. A problem with having a population dose themselves every week or two, is making sure people actually take their medicine. That's a general problem, getting people to take their prescribed medications. Especially with a 3-month injectable, inserted at the doctor's office I assume, it would be relatively straightforward for schools and public health departments to track who needs to get a new injection.

Edit: I wonder if the school nurse could do the injections. Do schools still have school nurses?

Excerpts from the posted PDF:

#Prophylactic strategy

The objective of the mdc-TTG program is to protect from Covid-19 with a subcutaneous injection of a 1-month active treatment of Ivermectin, a molecule already widely used in other indications. Since the beginning of the pandemic, clues about its potential efficacy against Covid-19 have piled up.

This prevention strategy called “pre-exposure prophylaxis” (PrEP) is similar to the one already used against HIV. People are protected for the duration of treatment. It has demonstrated its efficacy but also the need for long-acting injectable treatments, the only ones to guarantee the continuity of protection.

#A first clinical trial to accelerate the development of the long-acting injectable

mdc-TTG uses MedinCell’s BEPO® technology. Three products based on BEPO® technology are already in clinical trials in the United States, the most advanced one at the end of phase 31 .

The program aims at providing an injectable treatment in the form of a pre-filled syringe, ready-to-use, with 24-month stability at room temperature. BEPO® technology will allow the formation of a small subcutaneous depot, fully bioresorbable, at the time of injection. It will act as a mini pump that releases Ivermectin regularly until it disappears completely.

Ivermectin has already been administered as a single dose to hundreds of millions of patients around the world. Its safety has been demonstrated and documented2 . The clinical trial initiated today aims at validating its safety when taken regularly in oral form over 4 weeks to simulate the continuous release of the active ingredient by a long-acting injectable.

The current clinical trial will gradually evaluate three increasing doses by daily administration over 4 weeks in three successive cohorts of healthy volunteers. It will serve as a solid foundation for the regulatory development of the long-acting injectable formulation and its potential mass deployment.

#A formulation candidate ready to enter regulatory development before the end of the year

Concurrently with this first clinical trial, the first injectable formulations are currently being tested in vivo. MedinCell expects to have a 1-month active injectable ready to enter the preliminary preclinical stages of regulatory development by the end of 2020. A 3-month active product is also being formulated.

In a favorable scenario, MedinCell will apply for market authorization before the end of 2021. Indeed, the validation of the efficacy of Ivermectin by the numerous studies in progress and the persistence of the pandemic should allow mdc-TTG to benefit from accelerated regulatory pathway for clinical development.

The large-scale production capacities set up as part of the joint venture formed by MedinCell with Corbion, will enable the large-scale supply of the biocompatible polymers required for the production of tens of millions of doses.

In addition, several advanced discussions are underway with public and private partners to fund this program so that it has no impact on MedinCell’s cash visibility.

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This is great but the n is super small.

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This shows ng/ml after a (WA-REF) 200ug/kg dose, an 18mg dose and a 36mg dose (all oral doses, see the graph under "Pharmacokinetics":

Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773004/

Just for parasites, no SARS involved.

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As I understand it, this is not an efficacy trial -they are just testing the pharmokinetics/safety of the product. I wish them good luck, but if they are actually going to try to prove prophylaxis in a healthy population, it's going to be a massive undertaking, with tens of thousands of participants and a number of months needed to get a useful result.

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