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Clinical Trial Conducted by MedinCell Confirms the Safety of Continuous Administration of ivermectin

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Regulatory News:

MedinCell (Paris:MEDCL):

Clinical trial validates the safety of ivermectin taken daily in oral form, to simulate the continuous release of the active substance by a long-acting injection.

No side effects were observed with the three doses of ivermectin tested up to 100 µg / kg.

MedinCell develops several long-acting injectable formulations of ivermectin, the most advanced aims at preventing infection from Covid-19 and its mutants for several months.

Positive results of the safety study

"All our programs are developed in accordance with the highest ethical standards and on the basis of reliable scientific principles with a view to potential massive deployment. Proving the safety of ivermectin in regular daily administration over a long period was an essential step for our ivermectin programs, in particular mdc-TTG in Covid-19," said Joël Richard, Chief Development Officer at MedinCell.

Ivermectin has already been administered as a once-daily treatment to hundreds of millions of patients worldwide. Its safety as a once-daily treatment has been demonstrated and documented. 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.

After study completion and in regard of the expert review conducted by Professor Jacques Descotes1 (March 2021), the safety profile of ivermectin supports the progress of MedinCell programs using this molecule, in particular mdc-TTG against Covid-19 and mdc-STM against malaria.

Covid-19: The prophylactic strategy

"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. "

Currently in regulatory development, the mdc-TTG program aims to offer an injectable treatment in the form of a pre-filled syringe, ready to use, and stable for 24 months at room temperature. MedinCell’s BEPO® technology will allow the formation of a small subcutaneous deposit at the time of injection. It will act as a mini pump that releases ivermectin regularly until it disappears completely.

The long-acting formulation of ivermectin in the mdc-TTG program could provide protection against Covid-19 and its mutants for several months after a single injection. It could also be administered to people identified as Covid-19 contact cases to protect them.

About the clinical safety study

Study title

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

Participants

3 successive cohorts of 8 healthy volunteers (one cohort per dose)

Administration

Daily dose of Ivermectin or placebo taken orally for 4 weeks by each cohort

Doses tested

Cohort 1: 200 μg/kg (day 1) + 50 μg/kg daily (day 2 to 28)

Cohort 2: 200 μg/kg (day 1) + 75 μg/kg daily (Day 2 to 28)

Cohort 3: 200 μg/kg (day 1) + 100 μg/kg daily (day 2 to 28)

Authorization of clinical trials

MHRA (Medicines & Healthcare products Regulatory Agency – United Kingdom)

Study period

September 2020 – March 2021

About 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 140 people representing over 25 different nationalities.

This press release may contain forward-looking statements, especially on the Company’s progress of its clinical trials. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including the Company's registration document, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in the documents and reports to be published subsequently by the Company. In addition, these forward-looking statements speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements.

This press release is for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for the Company's shares in any jurisdiction, in particular in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be subject to legal restrictions in certain jurisdictions. Persons who come to know about this press release are required to inquire about and comply with these restrictions.

1 Jacques Descotes, Medical Safety of Ivermectin», March 2021 (www.medincell.com/ivermectin)

View source version on businesswire.com: https://www.businesswire.com/news/home/20210419005656/en/

Contacts

MedinCell
David Heuzé
Head of Communication
david.heuze@medincell.com
+33 (0)6 83 25 21 86

NewCap
Louis-Victor Delouvrier / Mathilde Bohin
Investor relations
medincell@newcap.eu
+33 (0)1 44 71 98 53

NewCap
Nicolas Merigeau
Media relations
medincell@newcap.eu
+33 (0)1 44 71 94 98