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Big Pharma Showcases New Treatment Targets at Alzheimer's Summit30 Jul 08New treatment targets have been showcased at ICAD 2008 in the United States, with global pharma firms touting experimental drug candidates.
Big Pharma's Involvement The 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008) in Chicago, United States, has provided a platform for updates on new therapy studies in the neuro-degenerative therapeutic area. Global pharma majors such as Pfizer, Wyeth, and Eli Lilly (all U.S.), among others, have indicated the findings of some of their key experimental candidates. Wyeth and Elan's bapineuzumab suffered a setback, demonstrating mixed results. Although the drug slowed memory loss in patients following a genetic test screening, there was no significant effect on the largest group of patients carrying the gene ApoE4. Furthermore, Bloomberg reports that the product was also linked to side effects such as brain swelling. Pfizer is showcasing nine abstracts including: the Phase II safety of receptor for advanced glycation end (RAGE) product PF-04494700's; the tolerability profile of PF-04494700 and PF-04360365 humanised anti-amyloid monoclonal antibody; data on blood biomarkers; and early research into additional compounds on enzyme inhibition in the brain. Eli Lilly's LY450139, an enzyme inhibitor in Phase III clinical trials, has shown promise, with the firm enrolling for further trials of 1,500 patients in 20 countries. The drug has demonstrated a reduction in amyloid beta production at higher dosages. Furthermore, intravenous experimental drug LY2062430 is expected to demonstrate dissolution and removal of plaque in the brain. This drug is currently in Phase II trials. Data from smaller players such as Myriad Genetics (U.S.) has increased interest in the therapeutic area. This includes a Phase II trial of PBT2 from Prana Biotechnology (Australia), a tau aggregation of methylthioninium chloride from tauRx Therapeutics called Rember, and Phase III studies of amyloid therapy Flurizan (tarenflyrbil). Although Myriad's data have not shown any effectiveness in final-stage trials, it demonstrates the increasing difficulty in establishing better treatment options that go beyond the course of providing relief symptoms. Placebo Effect Examining the role of disease progression in patients receiving placebo during a clinical trial for Alzheimer's has assumed significance. Two clinical studies—a review of 87 Alzheimer's clinical trials from 1991–2005 and a review of donepezil trials from 1990–99—have unearthed a link towards establishing the efficacy of the experimental drug. It was found that a placebo group size greater than 200 demonstrated a cognitive decline that could be compared optimally. The second study, involving Pfizer and Eisai's (Japan) Aricept (donezepil), indicated that patients with Alzheimer's entering later clinical trials were experiencing a slower rate of memory decline and thinking processes, making it challenging to establish the effects of the treatment being investigated. Outlook and Implications The summit has showcased some of the major potentials in terms of new treatment options in the Alzheimer's area. Amyloid, synapse formation, and the considerable progression in tau, which targets toxic tau aggregates or "tangles", have been highlights. Further large-scale human trials are expected to examine the safety and tolerability of Rember, which is currently in Phase II trials. Despite the excitement over potential new therapies, the summit reinforced some of the concerns in the therapeutic area relating to safety and side effects—Myriad's Flurizan and Wyeth and Elan's experimental drug being no exception. The challenges in providing treatment options that target the underlying course of the disease progression still remains elusive. This is an area where the experimental clinical studies are shifting, but it is coming increasingly difficult to establish links. Furthermore, studies indicating the placebo effect in clinical studies have demonstrated increasing problems in impressing the efficacy of the treatment. Here, clinical trials involving a larger patient population are expected to provide better results, thereby changing the structure of clinical trial studies. |
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