Three MedinCell products entering regulatory development

Published: 3-Feb-2021

Last April, the company announced the regulatory development of the mdc-WWM program, a contraceptive administered by subcutaneous injection, bioresorbable and active for six months

The MedinCell team has selected the lead formulation and started the regulatory preclinical development of three long acting injectable treatments targeting organ transplant rejection, COVID-19 and acute animal pain.

“With the admission of three new products into preclinical development and the achievement of this milestone for our contraceptive program last April, our team has achieved its goals” said Christophe Douat, CEO of MedinCell. “The most advanced product of our portfolio – whose pivotal Phase 3 ended with positive results – is only the tip of the iceberg. On top of this product which is about to enter the final stage of the approval process, Phase 3 should start this year for two other products”.

The three new programs into regulatory development are mdc-GRT, mdc-KPT and mdc-TTG.

GRT is intended to prevent graft rejection in organ transplant patients. It uses Tacrolimus, an immunosuppressant, as the active ingredient. In addition, to improve compliance, a major issue in patients who have received a transplant associated with a necessary lifelong treatment, this product could reduce the risk of adverse effects. The company hopes to launch the first in-human study in 2022.

MedinCell’s first animal health program, mdc-KPT is a 5- to 7-day treatment targeting acute pain for pets, based on an active ingredient already widely used. The regulatory activities, which have just started, should enable the beginning of the product’s clinical trials before the end of 2021.

The objective of the mdc-TTG program is to protect humans from COVID-19 and its variants with a long-acting injection of Ivermectin. A first formulation candidate potentially active for more than a month has entered regulatory preclinical development.

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