Schizophrenia Drugs: The Latest Developments
This SharePost will be devoted to schizophrenia drugs in the pipeline.
Bioline RX enrolled its first patient in their Phase II/III Clarity Trial for BL-1020. This compound is a first in class GABA-enhanced anti-psychotic treatment for schizophrenia.
The Clarity Trial is a randomized, double-blind, placebo-controlled study to be conducted in 15 sites in Romania and 19 sites in India. A total of 435 patients experiencing an acute exacerbation of schizophrenia will be enrolled.
The goal of the trial is to determine the short-term cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in SZ patients over a period of six weeks compared with Risperidone (Risperdal) and a placebo.
Working memory, attention, verbal and visual learning, reasoning and social cognition are the most important neurocognitive functioning domains that are impaired in schizophrenic minds. Clinical and non-clinical trials so far conducted suggest BL-1020 has the potential to improve cognition as well as treat other symptoms.
BL-1020 works by blocking action of the neurotransmitter dopamine while enhancing the activity of another neurotransmitter, GABA. In clinical trials, BL-1020 improved cognitive function in SZ patients.
In other news, Durect and Zogenix are in a deal to develop a long-acting version of Risperidone (Risperdal) greater than that of Risperdal Consta. The drug has yet to enter clinical trials. Relday will be given once-per-month as opposed to twice-per-month injections.
Another long-acting injectable, or LAI, in the pipeline comes from Alkermes Inc. ALKS-9070 is a once-a-month injectable extended-release version of Abilify (Aripiprazole) sold by Bristol-Myers Squibb. Data from the double-blind, randomized, placebo-controlled 20-week study indicated the drug was generally well-tolerated at all doses and obtained therapeutically relevant plasma concentrations of Abilify.
Alkermes is encouraged by the positive results and expects to begin a pivotal development program for the drug by the end of 2011.
Lastly, Allon Therapeutics Inc. revealed that 12 weeks of treatment with davunetide appears to prevent cortical thinning of important parts of the brains of SZ patients. Human imaging data support the neuroprotective effects of davunetide. A further larger-scale study is merited to replicate the findings. The hypothesis is that davunetide prevents brain atrophy.
The results showed the greatest treatment effect in the dorsolateral prefrontal and temporal cortical regions of the brain areas known to be impacted in cognitive impairment associated with schizophrenia (CIAS).
I'll report in the coming months on the progress of these and other trials.
The last SharePost for August will focus in detail on strategies for staying out of the hospital and what to do if you need to go to a hospital for treatment of your schizophrenia.