dm+d

Unassigned

New Medicines

Normo-CortCushing's disease; first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery

Information

Normo-Cort
New molecular entity
Cortendo
Cortendo

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Yes
Yes
Mar 21Filed in US for treatment of endogenous Cushing’s syndrome [17].
Jan 21Stonebridge announce plans to submit NDA to FDA Q1 21 are on-track [16].
Nov 19Strongbridge plan to file NDA with FDA Q1 21 [13].
May 19Strongbridge plan to file NDA based on results of PIII SONICS and LOGICS studies by end Q3 2020 [11].
Mar 15Generic name now levoketoconazole; orphan drug status in EU, US for Cushing syndrome [3].

Category

2S, 4R-enantiomer of ketoconazole
22 January 2016The prevalence of endogenous Cushing’s syndrome is 1 in 26,000 in the EU, with an annual incidence of between 1 in 1,400,000 and 1 in 400,000. Incidence peaks at 25-40 years of age [6].
Cushing's disease; first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery
Oral

Trial or other data

Nov 20Strongbridge report positive secondary endpoint results from PIII SONICS study. Significant mean improvements from baseline were noted at end of the maintenance phase for acne, hirsutism (females only), and peripheral oedema. The study previously met its primary endpoint of significant normalisation rate of urinary free cortisol at six months [15].
Sep 20Strongbridge report positive results from pivotal PIII LOGICS study. At the end of the randomised-withdrawal phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol response as compared with those who remained on treatment (95.5% vs 40.9% respectively; p=0.0002) [14].
Nov 19Topline results from PIII LOGICS trial are now expected Q3 20 [13]
Sep 19PIII SONICS study (n=94) found normalisation of urinary free cortisol levels after 6 months maintenance therapy (without dose increase after establishing therapeutic dose) in~30% of patients [12].
May 19Topline results from PIII LOGICS study expected Q1 2020 [11].
Dec 18PIII study NCT01838551 has completed. Estimated primary completion date of PIII NCT03277690 is March 2019 [9].
Oct 18Strongbrige are amending clinical trial protocol for ongoing PIII LOGICS study (NCT03277690) to expand patient target from 35 to 54 patients. Top-line results are expected Q4 2019 [10].
Jan 18Estimated primary completion date of NCT01838551 is April 18. Second PIII study NCT03277690 is not yet recruiting [8].
Jan 17Strongbridge plan to initiate a second global PIII study of COR-003 (LOGICS). Recruitment of approximately 35 patients will begin mid- 2017; two-thirds of patients will have completed the SONICS study [7].
Oct 16Strongbridge announce completion of Data and Safety Monitoring Board (DSMB) review of NCT01838551, which recommended continuation of the trial without any modifications. Regulatory filings are anticipated in second half of 2017 [7].
Dec 15Planned End Date for NCT01838551 changed from 1 Jun 2016 to 1 Nov 2017 and planned primary completion date changed from 1 Jan 2016 to 1 May 2017 [5].
Jul 15Top-line data during the first half of 2017 [4].
Aug 14NCT01838551 is a PIII open-label study of ascending doses of COR-003 in 90 subjects with elevated levels of cortisol due to endogenous Cushing´s Syndrome The primary outcome is reduction in Urinary Free Cortisol (UFC) concentrations; response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The first patient was dosed in Aug 14 and the study is due to complete Jan 16 [1,2]