Date: 2016-04-28
Type of information: Interim results
phase: 1
Announcement: interim results
Company: Alkermes (Ireland)
Product: ALKS 7119
Action
mechanism: ALKS 7119 is the newest candidate in Alkermes’ pipeline of novel medicines for CNS diseases. ALKS 7119 has a multivalent mechanism of action that acts on key receptors in the brain involved in several CNS diseases, including agitation in patients with Alzheimer’s disease, MDD and others
Disease: treatment of agitation in patients with Alzheimer’s disease, major depressive disorder (MDD) and other central nervous system (CNS) indications
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country:
Trial details:
Latest
news: * On April 28, 2016, Alkermes announced preliminary findings from a phase 1 clinical trial of ALKS 7119, an oral, novel small molecule that acts on multiple key receptor systems in the brain. ALKS 7119 is being developed for the treatment of agitation in patients with Alzheimer's disease and other central nervous system (CNS) indications. Based on initial blinded data from the ongoing single-ascending-dose study, Alkermes has accelerated the decision to advance ALKS 7119 into a multiple-ascending-dose phase 1 study. The study is planned to commence in the third quarter of 2016 and results are expected around year-end. Initiated in January 2016 , the double-blind, placebo-controlled single-ascending-dose study was designed to evaluate the safety and tolerability, as well as the pharmacokinetic properties of ALKS 7119 in healthy volunteers. Preliminary data from the first six escalating dose cohorts demonstrated a favorable tolerability profile for ALKS 7119 and pharmacokinetic properties consistent with potential once-daily dosing. Full results from the ongoing single-ascending-dose phase 1 study, including unblinded safety data, are expected in the second half of 2016.
* On January 25, 2016, Alkermes announced the initiation of a phase 1 clinical study of ALKS 7119, an oral, investigational drug candidate being developed for the treatment of agitation in patients with Alzheimer's disease and other central nervous system indications. The double-blind, placebo-controlled study will evaluate the safety and tolerability of single ascending doses of ALKS 7119 in approximately 60 healthy subjects. The randomized, double-blind, placebo-controlled, multi-cohort, phase 1 study will investigate the safety and tolerability of single ascending doses of ALKS 7119 following oral administration in approximately 60 healthy male adults. The study will also include a battery of psychometric assessments, which are intended to provide preliminary insight into the potential human pharmacodynamic response. Results from this phase 1 study are expected in the second half of 2016.
* On March 2, 2015, Alkermes announced a new drug candidate, ALKS 7119, for the treatment of agitation in patients with Alzheimer’s disease, major depressive disorder (MDD) and other central nervous system (CNS) indications. Alkermes has successfully completed preclinical development and expects to initiate the first clinical study of ALKS 7119 in the third quarter of 2015. Additional details about ALKS 7119 will have been presented at an Analyst and Investor Event hosted by Alkermes. Alkermes intends to file an Investigational New Drug (IND) application with the FDA in the second quarter and begin clinical trials in the third quarter of 2015. A number of patent applications have been submitted to the U.S. Patent and Trademark Office related to ALKS 7119.
