Balance Therapeutics is evaluating an investigational new drug BTD-001, to treat excessive daytime sleepiness in individuals diagnosed with idiopathic hypersomnia (IH) or narcolepsy type 2 (Na-2). A Phase 2 clinical trial is currently enrolling Na-2 subjects at 26 investigational centers in the United States. Individuals currently diagnosed as “IH” who may have previously been diagnosed as narcolepsy may also qualify. For more information regarding the study and participating site locations, and if you are interested in participating in this trial, please visit the website www.arisestudies.com.
Recent research published by a team from Emory University in Atlanta, Georgia has demonstrated that the excessive daytime sleepiness in many individuals diagnosed with idiopathic hypersomnia (IH) and narcolepsy type 2 (narcolepsy without cataplexy; Na-2) is driven by accumulation of a naturally occurring substance, yet to be identified, that increases the function of the sleep promoting neurotransmitter γ (gamma)-amino-butyric acid (i.e., GABA) in the brain.
The investigational drug BTD-001 is known to suppress GABA activity. BTD-001 is therefore targeted more directly at emerging mechanisms thought to cause the excessive sleepiness of many patients diagnosed with IH and Na-2. It is also unique from current FDA approved therapeutic approaches for alleviating the excessive daytime sleepiness in individuals diagnosed with IH and Na-2.