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News Breaks
July 15, 2014
07:01 EDTTTHITransition Therapeutics initiated with a Buy at H.C. Wainwright
Target $10.
News For TTHI From The Last 14 Days
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June 24, 2015
16:21 EDTTTHIOn The Fly: Top stock stories for Wednesday
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06:08 EDTTTHITransition Therapeutics reports ELND005 did not meet primary efficacy endpoint
Transition Therapeutics announced that a Phase 2/3 clinical study of neuropsychiatric drug candidate ELND005 did not meet its primary efficacy endpoint. In the study, both the treatment and placebo groups showed a significant, but similar, reduction in agitation and aggression relative to baseline. There was a greater than expected reduction in agitation and aggression observed in the placebo group as measured in weeks 4, 8 and 12 in the study. The safety and tolerability profile of ELND005 was consistent with previous studies in AD at the 250mg bid dose. The Phase 2/3 clinical study evaluated the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with mild to severe AD, who were experiencing at least moderate levels of agitation/aggression. The randomized, double-blind, placebo-controlled study enrolled 350 AD patients. The primary efficacy endpoint of the study was the change from baseline in the Neuropsychiatric Inventory Clinician scale of agitation and aggression. An analysis of the full study dataset is being performed. An external clinical advisory committee will be consulted in determining any future development of ELND005. Data from the Phase 2/3 clinical study will be presented at a future medical meeting.
06:04 EDTTTHITransition Therapeutics announces ELND005 study did not meet primary endpoint
Transition Therapeutics announced that a Phase 2/3 clinical study of neuropsychiatric drug candidate ELND005 did not meet its primary efficacy endpoint. In the study, both the treatment and placebo groups showed a significant, but similar, reduction in agitation and aggression relative to baseline. There was a greater than expected reduction in agitation and aggression observed in the placebo group as measured in weeks 4, 8 and 12 in the study. The safety and tolerability profile of ELND005 was consistent with previous studies in AD at the 250mg bid dose. The Phase 2/3 clinical study evaluated the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with mild to severe AD, who were experiencing at least moderate levels of agitation/aggression. The randomized, double-blind, placebo-controlled study enrolled 350 AD patients. The primary efficacy endpoint of the study was the change from baseline in the Neuropsychiatric Inventory Clinician scale of agitation and aggression. An analysis of the full study dataset is being performed. An external clinical advisory committee will be consulted in determining any future development of ELND005.

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