May 22 (Reuters) - Medincell SA MEDCL.PA :
* PHASE 1 DATA OF MDC-TJK INVESTIGATIONAL LONG-ACTING
INJECTABLE
OF OLANZAPINE FOR SCHIZOPHRENIA PATIENTS, EXHIBITED FAVORABLE
CHARACTERISTICS OF AN EXTENDED-RELEASE PROFILE
* MDC-TJK HAS POTENTIAL TO BE FIRST LONG-ACTING INJECTABLE
OF
OLANZAPINE WITH A FAVORABLE SAFETY PROFILE
* DATA CAME FROM A 127-PARTICIPANT PHASE 1 CLINICAL STUDY
* NO BURST OR UNCONTROLLED RISE IN OLANZAPINE PLASMA
CONCENTRATIONS FOLLOWING MDC-TJK SUBCUTANEOUS ADMINISTRATION WAS
OBSERVED
* AT STEADY-STATE CONDITIONS OVER 28 DOSING INTERVAL,
SYSTEMIC
EXPOSURE OF MDC-TJK AT DOSES 318, 425 AND 531 MG WERE COMPARABLE
TO ORAL DAILY CORRESPONDING DOSES 10 MG, 15 MG, AND 20 MG
* REACHING CLINICALLY RELEVANT THERAPEUTIC OLANZAPINE PLASMA
CONCENTRATIONS (≥ 10 NG/ML) WITHIN A 1 TO 2 DAY AND MAINTAINING
THEM DURING 28-DAY DOSING INTERVAL
* RESULTS OF THIS STUDY SUPPORTED DOSE SELECTION OF MDC-TJK
IN
ONGOING PHASE 3
Source text for Eikon: ID:nBw2JRGNva
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