On Thursday, Shares of Aeterna Zentaris Inc. (NASDAQ:AEZS), declined -2.44% to $0.0680.
Aeterna Zentaris, traded on a volume of 18,515,567, lower than its standard daily volume. The stock, as of recent close, has shown weekly downbeat performance of -24.86% which was maintained at -89.37% in this year. Over the last twelve months, the stock has lost $-1.21 (-94.69%) and faced a worst price of $0.05 on Sep 18, 2015. The stock has moved down across its 50-day moving average of $0.08.
Aeterna Zentaris Inc., a specialty biopharmaceutical company, engages in developing and commercializing novel treatments in oncology, endocrinology, and women’s health.
On other hand, Shares of Transition Therapeutics Inc. (NASDAQ:TTHI), surged 3.11% to $1.99.
Transition Therapeutics, declared that its partner, Transition Therapeutics Ireland Limited, has accomplished a thorough review of the data related to the Phase 2/3 study of ELND005 in Alzheimer’s disease patients with moderate or severe agitation and aggression. The analysis identified a noteworthy clinical benefit of ELND005 in AD patients with severe agitation and aggression, and will serve as the basis for patient selection in a Phase 3 clinical study. The review was performed in consultation with a group of key opinion leaders in the field of neuropsychiatry.
Efficacy Findings
As formerly declared, the primary efficacy endpoint of the Phase 2/3 study (12 week change from baseline of the NPIC A+A scale) was not achieved in the overall study population of AD patients with moderate or severe agitation and aggression.
A post-hoc analysis demonstrated that ELND005 offered a clinically meaningful 5.1 point improvement relative to placebo on the NPIC A+A scale (p=0.047) in a severe agitation and aggression population. An evaluation of progressively severe patient subsets with baseline NPIC A+A scores greater than 22 showed a consistent and greater improvement over the 5.1 points observed in the overall severe population. Multiple analyses performed on the severe agitation and aggression dataset determined that outliers, baseline demographics, AD severity, and concomitant medications did not appear to contribute to the improvement observed in the ELND005 treatment group.
The NPIC A+A scale is an aggregate score of severity related to 21 behavioral symptoms (13 agitation, 8 aggression behaviors). Analysis of the patient population with a baseline NPIC A+A < 22 showed that the major symptoms manifested were upset, stubborn, resistance, ask and shouting, and the remaining 16 behavioral symptoms were much less prevalent and had lower severity. As the baseline severity of NPIC A+A raised above 22 in AD patients, particularly above 26, many of the verbal and physical aggression items (hit, push, intrusive, argue, complain, danger, slam conflict), in addition to the excessive motor activities (restless, fidget, pace), also raised in prevalence and severity. In this population of AD patients with severe agitation and aggression, 20 of the 21 symptoms measured by the NPIC A+A numerically favored ELND005 relative to placebo. These data demonstrated that ELND005 appeared to have a more pronounced effect on the verbal and physical aggression symptoms, in addition to the excessive motor activities, that were more prevalent in AD patients with increasing agitation and aggression disease severity.
Safety and Tolerability Results
ELND005 was shown to have an acceptable safety and tolerability profile in the study. The overall incidence of treatment emergent adverse events (“TEAEs”) in the ELND005 group and the placebo group were similar (56.6% vs 54.3%), as was the incidence of study drug-related TEAEs (13.1% vs 14.9%). Most TEAEs were mild or moderate in severity. The most common TEAEs in the ELND005 group that were ≥5% in incidence were: agitation (8.0% vs. 7.4% in placebo), diarrhea (8.0% vs. 2.9% in placebo), urinary tract infection (6.9% vs. 4.0% in placebo), and falls (6.3% vs. 5.1% in placebo). Overall, the incidence of serious adverse events was higher in the ELND005 group (9.7%) contrast with the placebo group (2.9%). There were no deaths stated in the study. The overall patient discontinuation rate was low (10.3%); 4.6% of patients suspended the study due to an adverse event in the ELND005 group as compared to 4.0% in the placebo group. No clinically meaningful changes in electrocardiographic findings were observed. ELND005 was not associated with cognitive impairment or sedation in this study.
Transition Therapeutics Inc., a biopharmaceutical company, researches and develops therapeutic agents for disease indications primarily in Canada. The company’s lead central nervous system drug candidate is ELND005, which has accomplished a Phase II/III clinical trial for the treatment of agitation/aggression associated with Alzheimer’s disease; and has accomplished Phase IIa clinical trial for the treatment of Down syndrome.
