Millendo Therapeutics begins human trial of VMS drug candidate MLE-301

Millendo Therapeutics has started a phase 1 clinical trial of its selective neurokinin 3 receptor (NK3R) antagonist MLE-301, which is being developed for the treatment of menopausal women with vasomotor symptoms (VMS).

VMS is known commonly as hot flashes and night sweats in menopausal women.

The Michigan-based biopharma company has dosed the first subject in the early-stage trial which will assess the safety, pharmacokinetics, and preliminary efficacy of MLE-301 the NK3R antagonist.

The first-in-human trial will evaluate the safety and tolerability of MLE-301. The single ascending dose part of the study will be carried out in healthy male volunteers for determining MLE-301’s pharmacokinetics and its pharmacodynamic profile as measured by reductions of biomarkers.

The phase 1 multiple ascending dose part of the clinical trial will feature post-menopausal women, which will enable measurement of reductions in VMS frequency and severity, and for establishing initial clinical proof of concept.

Julia C. Owens – President and CEO of Millendo Therapeutics said: “We are pleased to advance MLE-301 into clinical development, prioritizing our resources on this valuable asset and leveraging Millendo’s expertise in the NK3R category.

“The company is focused on executing our Phase 1 study and understanding more about the safety, PK/PD and efficacy profile of MLE-301 based on the resulting data from this study.”

Millendo Therapeutics said that preclinical data showed potency and selectivity for MLE-301, the potential for daily once dosing, and testosterone reducing effects that are consistent with the expected actions of an NK3R antagonist.

Christophe Arbet-Engels – Chief Medical Officer of Millendo Therapeutics said: “Over 20 million women in the U.S. suffer from VMS associated with menopause, including hot flashes and night sweats that can severely impact quality of life, overall productivity and long-term healthcare utilization.

“With symptoms that last on average over seven years, there is still a critical need for an effective, non-hormonal treatment that has the efficacy of estrogens but without the increased risks of cancer or cardiovascular disease.”