Nevanimibe HCl for the Treatment of Classic CAH

Phase 2 Terminated 15 enrolled Millendo Therapeutics US, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.

Timeline

Start: 2018-07-11
Primary completion: 2020-06-03
Completion: 2020-07-12

Outcome

Outcome not reported

Stopped: “Following an interim data review, further investment in nevanimibe has been discontinued”

Publications

White PC. Emerging treatment for congenital adrenal hyperplasia. Curr Opin Endocrinol Diabetes Obes. 2022 Jun 1;29(3):271-276. doi: 10.1097/MED.0000000000000723.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nevanimibe	Small molecule	500 mg	Oral
Subject	Nevanimibe	Small molecule	1000 mg	Oral
Subject	Nevanimibe	Small molecule	1500 mg	Oral
Subject	Nevanimibe	Small molecule	2000 mg	Oral