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Millendo Provides Corporate And Pipeline Update; Says Has Engaged SVB Leerink To Support Strategic Review Process

– MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, advancing with first-in-human trials expected to initiate in 3Q20 – – Further investment in nevanimibe for congenital adrenal hyperplasia

Benzinga · -

– MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, advancing with first-in-human trials expected to initiate in 3Q20 –

– Further investment in nevanimibe for congenital adrenal hyperplasia (CAH) not planned following interim data review –

– Strategic evaluation in place to determine future corporate strategy –

Millendo Therapeutics, Inc. (NASDAQ:MLND), a biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, announced today that it has taken steps forward in its evaluation of strategic options to determine the company's future direction. As part of these efforts, Millendo has engaged SVB Leerink to support the strategic review process. The company finished Q1 2020 with $58.9 million in cash, cash equivalents and restricted cash.

"Our board of directors and leadership team recognize the importance of conducting a comprehensive and strategic review. We are aligned in our focus on evaluating our pipeline and its potential, beginning with the advancement of MLE-301," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "Our objective is to come away from this process with an actionable plan that leverages our assets, capital and capabilities in a way that maximizes shareholder value."

MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, continues to advance to first-in-human trials: An IND has been filed to study MLE-301 for the treatment of vasomotor symptoms (VMS), also known as hot flashes and night sweats, in menopausal women. VMS currently impact 70% of peri/post-menopausal women, representing over 20 million women in the US. Phase 1 clinical studies are expected to initiate in 3Q20.

Interim review of nevanimibe open-label Phase 2b study in CAH completed: Results from 10 subjects, nine from cohort 1 and one from cohort 2, with at least 12 weeks of treatment with nevanimibe in this open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal (ULN). Treatment under the amended protocol with dose titration starting at 500 mg BID improved tolerability of nevanimibe. However, based on the observed level of nevanimibe activity and the changing competitive environment, no further investment in the program is currently planned.

About MLE-301

MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin) neurons, which are believed to participate in the generation of VMS. By inhibiting the NK3R signaling on the KNDy neurons and potentially other NK3R-expressing neurons that propagate heat dissipation signals through the hypothalamus, MLE-301 aims to reduce the effects of hyperactive KNDy neurons and thereby address vasomotor symptoms.

About Nevanimibe

Nevanimibe decreases adrenal steroidogenesis through the inhibition of acyl coenzyme A: cholesterol acyltransferase 1, or ACAT1, and is being studied for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems. An interim review of data from the Phase 2b trial of nevanimibe in CAH (NCT03669549) was conducted; results from 10 subjects with at least 12 weeks of treatment with nevanimibe in the open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal (ULN).