PRESS RELEASE
Accera, Inc. Announces Open-Label Data from Phase II Study in Alzheimer’s Disease at
International Conference on Prevention of Dementia
Broomfield, CO, June 11, 2007 – Accera, Inc. today is presenting data from an open-label extension of its Phase IIb clinical trial of AC-1202 (Ketasyn™) in Alzheimer’s disease (AD) at the Alzheimer’s Association’s International Conference on Prevention of Dementia in Washington, D.C. Consistent with the findings of earlier clinical and preclinical studies, AC-1202 was shown to be safe and to significantly improve the memory and cognition of subjects of a particular pharmacogenomic profile.
The randomized, double-blinded, placebo-controlled Phase IIb trial evaluated 152 subjects that had previously been diagnosed with mild to moderate AD at 25 centers across the United States. AC-1202 was administered once daily, and most patients continued to take their other AD drugs such as acetylcholinesterase inhibitors. Following three months of treatment and a two-week washout, eligible subjects were given the opportunity to receive AC-1202 in a six-month open-label extension study. The main clinical outcome for efficacy was improvement in the AD Assessment Scale-Cognitive (ADAS-Cog) score, which measures memory and other aspects of cognitive performance.
In the double-blind phase of the clinical study the ADAS-Cog scores of the AC-1202-treated ApoE4(-) population improved 3.5 points in twelve weeks (p=0.01) compared to the placebo group, and statistically significant improvement was seen in just 45 days. ApoE4(-) subjects who also exhibited a genetic variation that affects glucose regulation showed a 5 point improvement in ADAS-Cog scores compared to placebo, providing further insight into the disease.
As in the double-blind phase of the study, the most profound effect was seen in subjects not expressing the ApoE4 genotype, a genetic risk factor for AD. ApoE4(-) subjects represent the other half of Alzheimer’s patients. ApoE4(-) subjects who started taking AC-1202 on the open-label extension rapidly showed significant improvement in memory and cognition, while AC-1202 appeared to have a disease stabilizing effect on subjects expressing the ApoE4 genotype (ApoE4(+)). Regardless of genotype, all subjects who remained on AC-1202 for all nine months of the study showed very little disease progression, declining only 0.8 points below baseline in ADAS-Cog scores in contrast to the 5.4-point decline observed in placebo subjects extrapolated to nine months.
“The significant and rapid cognitive improvements observed in ApoE4(-) patients supports the efficacy observed in our Phase IIa study,†said Dr. Lauren Costantini, Accera’s vice president of clinical development. “It also provides further evidence of the link between Alzheimer’s disease and neuronal hypometabolism,†she added, referring to AC-1202’s novel mechanism of action.
AC-1202 continued to be well tolerated by subjects in the open-label extension study, providing an additional six months of safety data. The incidence of treatment-related gastrointestinal side effects was similar to that of other AD drugs in the double-blind phase of the study, but a reformulated version of AC-1202 used in the open-label extension study greatly reduced these side effects.
“The excellent safety profile of AC-1202 in addition to its efficacy on top of existing AD drugs makes it a strong candidate for a co-therapeutic approach to the treatment of Alzheimer’s disease,†said Dr. Steve Orndorff, CEO of Accera.
Open-Label results were highlighted in a “Late Breaking News†press conference today at 1:30 p.m. (EDT) by the Alzheimer’s Association. The 2nd Annual International Conference on Prevention of Dementia, a multidisciplinary forum for professionals from the fields of bench research, drug discovery, medicine, care and public policy, is hosted by the Alzheimer’s Association, the leading voluntary health organization in Alzheimer care, support and research.
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