The Irish subsidiary of biopharmaceutical company Transition Therapeutics Inc. has finished patient enrollment for its phase 2 clinical study to assess a novel therapy for mild, moderate and severe Alzheimer’s disease. Transition Therapeutics Ireland Limited (TTIL) will now evaluate the neuropsychiatric drug candidate ELND005, expecting it to reduce both agitation and aggression.
TTIL is going to conduct the phase 2 randomized, double-blind, placebo-controlled Harmony AD clinical study in order to assess the efficacy, safety and tolerability of the drug ELND005 across 12 weeks of therapy. The study will include 350 patients who suffer from mild to severe Alzheimer’s and experience at least moderate agitation or aggression, according to a press release from the company.
The Harmony AD Study will take place at 69 clinical sites in the United States, Canada, Spain and the United Kingdom, and will have as its primary efficacy endpoint alterations in patients’ agitation and aggression, as measured by the Neuropsychiatric Inventory – Clinician (NPI-C) scale. The company expects to be able to present top-line data by the middle of the year.
ELND005 is orally administrated and is currently being tested by TTIL for several neuropsychiatric symptoms. The drug works with a dual mechanism of action, with β-amyloid anti-aggregation and by regulating the levels of myo-inositol in the brain.
Previous phase 1 and phase 2 studies have already been conducted to evaluate ELND005 and support its clinical development. Due to its innovative formulation, potential as a treatment of Neuropsychiatric Symptoms and the lack of approved therapies that address the symptoms, the drug has been granted fast track designation by the U.S. Food and Drug Administration (FDA). In addition to Alzheimer’s disease, TTIL is also evaluating ELND005 for Down syndrome.
Alzheimer’s disease is widely known for causing the gradual decline of elderly individuals’ memory, learning capacities, reason, judgment and communication ability. However, the progressive brain condition also causes neuropsychiatric symptoms in 90% of the patients, with 60% manifesting agitation and aggression after being diagnosed. These symptoms are not only some of the most disruptive psychiatric manifestations, but are also related to an increase in mortality and morbidity, as well as with the burden of caregivers.
Agitation and aggression in Alzheimer’s disease patients have become major concerns in the medical field and are gaining the attention of investigators. Avanir Pharmaceuticals, Inc. presented results from two clinical trials that evaluated AVP-923’s safety, tolerability, and efficacy for the treatment of agitation in Alzheimer’s patients, at the American Neurological Association’s (ANA) Annual Meeting in October.
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