MedinCell’s Long-Acting Injectable to Fight Malaria Ready to Enter Regulatory Development

0
14

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:

MedinCell (Paris:MEDCL) and the project consortium members, IRD, IRSS and CIRDES, have successfully designed, tested, and confirmed with Unitaid the selection of the lead formulation. Regulatory preclinical activities are starting with the objective of a first clinical trial in 2023.

MedinCell and the consortium members have conducted an in vivo proof of concept on cattle that showed a 3-month mosquitocidal effectiveness of an injectable long-acting formulation of Ivermectin based on the proprietary BEPO® technology.

The investigational product mdc-STM aims at reducing the transmission of the parasite responsible for Malaria, thanks to a killing effect on the vector mosquitoes when they bite treated people.

Malaria remains one of the main health threats worldwide with more than 200 million people infected yearly.

In March 2020, global health agency Unitaid granted MedinCell with a $6.4 million subvention over three years to conduct the formulation and preclinical activities of the program.

mdc-STM benefits from synergies with other MedinCell’s programs based on Ivermectin all of them using different formulation and doses fitted to their specific indications.

MedinCell has been collaborating for more than 10 years with IRD, IRSS and CIRDES to conduct in vivo studies in Burkina Faso about tackling residual transmission of Malaria. These partners provide theoretical and practical scientific expertise on malaria and vectors, and the essential field infrastructure to support the demonstration of a 3‑month active injectable ivermectin formulation against malaria vectors. Administered once to exposed populations at the start of the rainy season, which is the period of highest risk of transmission, the investigational product could have a significant impact on malaria incidence and prevalence in Africa where the burden is the highest.

Malaria remains pandemic in 91 countries representing 50% of the world’s population. According to WHO estimates, 228 million people were infected worldwide in 2018, 93% of them in Africa, leading to 405,000 deaths. Children under 5 years are the most vulnerable, accounting for 67% of deaths from malaria.

Ivermectin has a long track record of use as a safe and effective drug to treat several parasitic diseases, such as river blindness. Its safety in continuous dosing over 1-month has been demonstrated by a recent randomized placebo-controlled clinical trial sponsored by MedinCell, in which ivermectin was orally administered daily, to simulate the continuous release of the active substance by a long-acting injection. This study and the expert review recently conducted by Pr. Jacques Descotes about the safety profile of ivermectin supports the progress of MedinCell programs using Ivermectin.

Unitaid aims at expanding access to much-needed drugs and diagnostics. Unitaid has committed to accelerate the impact of long-acting technologies in LMICs by supporting the development of innovative products that could redefine prevention and treatment of infectious diseases like HIV, TB, Malaria and hepatitis C. MedinCell has been the first private company to receive support from Unitaid to help develop and commercialize long-acting medicine.

By supporting MedinCell and the consortium, Unitaid is investing in finding additional solutions to prevent the spread of malaria and in making them more accessible. According to the agreement, the Unitaid-funded Medicines Patent Pool – in charge of licensing agreements for the exploitation of patents for medicines in low- and middle-income countries – will receive a non-exclusive royalty free license to ensure distribution of the final product via public sector in LMICs.

MedinCell will keep potential benefits of marketing rights of the product worldwide and for all potential additional indications where this formulation might have an impact.

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.

www.medincell.com

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.

Contacts

MedinCell

David Heuzé

Head of communication

[email protected]
+33 (0)6 83 25 21 86

NewCap

Louis-Victor Delouvrier

Relations investisseurs

[email protected]

+33 (0)1 44 71 94 94

NewCap

Nicolas Merigeau

Media Relations

[email protected]

+33 (0)1 44 71 94 94