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|May 05, 2017 2:00 p.m.|
|Teva and Active Biotech Announce CONCERTO trial of Laquinimod in RRMS Did Not Meet Primary Endpoint|
Other data details announced by the Company show that on the secondary endpoint which measured change in brain volume-- an indicator of disability progression over time-- compared to baseline was positive (40% improvement over placebo at month 15, p < 0.0001). Other encouraging results were seen on the secondary endpoint of time to first relapse (risk reduced by 28%; p = 0.0001) and the exploratory endpoint of annualized relapse rate (risk reduced by 25%; p=0.0001). As with the primary endpoint, secondary endpoints measuring time to CDP at 6 and 9 months did not reach significance. On the exploratory endpoint of reduction of the number of gadolinium-enhancing T1 lesions at month 15, laquinimod demonstrated a 30% reduction (p=0.004).
“We have learned a great deal from the CONCERTO trial and we will
continue our analysis of the data,” said
The clinical safety profile of laquinimod 0.6 mg daily, which had been previously studied with over 12,000 patient-years of exposure, was confirmed in CONCERTO. Adverse events reported in 5% or more of CONCERTO patients taking 0.6 mg daily of laquinimod were headache (17%), nasopharyngitis (9%), back pain (7%), and arthralgia (5%).
Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting.
CONCERTO is a multinational, multicenter, randomized, double-blind,
parallel-group, placebo-controlled study followed by an active treatment
period, to evaluate the efficacy, safety and tolerability of two oral
doses of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with RRMS.
The higher-dose (1.2 mg) arm of the trial was discontinued in
Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing -remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.
This information is information that
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Laquinimod, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Pharmaceutical Industries Ltd.