Date: 2015-05-07
Type of information: Results
phase: 1
Announcement: results
Company: Jazz Pharmaceuticals (Ireland) Concert Pharmaceuticals (USA - MA)
Product: JZP-386 (sodium oxybate analog)
Action
mechanism: JZP-386 is a deuterium-containing analog of sodium oxybate—the active ingredient in Xyrem® (sodium oxybate) oral solution. Sodium oxybate is the active ingredient in Xyrem®, a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy.
Disease:
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial
details: The Phase 1 clinical trial is designed to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of JZP-386, and includes Xyrem® as an active control. The study is expected to enroll up to 28 healthy subjects at a single center in Europe. The results of the study are intended to assess the PK/PD profile of JZP-386 to identify a safe and tolerable dose or doses of JZP-386 that could be used in subsequent clinical trials and to determine whether JZP-386 is suitable for once nightly dosing.
Latest
news: * On May 7, 2015, Jazz Pharmaceuticals and Concert Pharmaceuticals announced results from the recently completed Phase 1 clinical study of JZP-386, a deuterium-containing analog of sodium oxybate. The Phase 1 study evaluated the safety, pharmacokinetics and pharmacodynamics (PD) of JZP-386 in 30 healthy volunteers. Clinical data from this Phase 1 study demonstrated that JZP-386 provided favorable deuterium-related effects, including higher serum concentrations and correspondingly increased PD effects at clinically relevant time points compared to Xyrem® (sodium oxybate) oral solution. The safety profile of JZP-386 was similar to that observed with Xyrem. While the companies have determined that the deuterium-related effects observed in the Phase 1 studies do not support advancing into a later-stage clinical trial of JZP-386 at this time, the results indicate that further evaluation of JZP-386 is warranted. Accordingly, the companies intend to explore formulation options to enhance the positive effects observed in the studies to achieve an improved product profile for patients with narcolepsy. * On December 9, 2014, Jazz Pharmaceuticals and Concert Pharmaceuticals,announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue. The existing Phase 1 clinical data was generated in a first-in-human trial evaluating the safety, pharmacokinetics, and pharmacodynamics of JZP-386; enrollment was completed in the third quarter. A second Phase 1 trial evaluating JZP-386 at the originally planned highest dose is expected to be initiated in the first quarter of 2015, with data expected in the second quarter of 2015. * On July 21, 2014, Jazz Pharmaceuticals and Concert Pharmaceuticals announced the initiation of the first Phase 1 clinical trial of JZP-386, a deuterium-containing analog of sodium oxybate--the active ingredient in Xyrem® (sodium oxybate) oral solution. The Phase 1 clinical trial is designed to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of JZP-386, and includes Xyrem as an active control. The study is expected to enroll up to 28 healthy subjects at a single center in Europe. The results of the study are intended to assess the PK/PD profile of JZP-386 to identify a safe and tolerable dose or doses of JZP-386 that could be used in subsequent clinical trials and to determine whether JZP-386 is suitable for once nightly dosing. Under its 2013 agreement with Concert, Jazz Pharmaceuticals has worldwide rights to develop and commercialize JZP-386. Concert has the potential to realize milestone payments upon meeting development objectives and tiered royalties on any worldwide sales. Jazz Pharmaceuticals and Concert are working collaboratively on development of JZP-386, and Concert is responsible for conducting clinical activities for JZP-386 through Phase 1.
