“We are encouraged by the results of this Phase 1 clinical trial in ADS-4101 and look forward to advancing the program in 2017,” Gregory T. Went, PhD, chairman and CEO of Adamas Pharmaceuticals, said in a recent press release.
“With our confirmed understanding that epileptic seizures primarily occur during the day, we are developing ADS-4101 to deliver high concentrations of medicine during the day when seizures occur. We believe ADS-4101’s promising profile may potentially provide a clinically meaningful benefit to patients with epilepsy,” Went said.
The Phase 1 clinical trial compared the safety and drug properties profile (pharmacokinetics) of four oral formulations of ADS-4010 with Vimpat (lacosamide) capsule formulations in 24 healthy volunteers. The clinical trial was also designed to guide the selection of an ADS-4101 formulation to be tested in further clinical trials (primary endpoints).
Leveraging Adamas’ discovery platform, ADS-4101 is a chrono-synchronous lacosamide, an active ingredient with anti-epileptic properties marketed as Vimpat (lacosamide). The drug was approved by the U.S. Food and Drug Administration (FDA) in September 2014 and in the European Union in December 2016, for the treatment of partial-onset seizures in adult and adolescent patients with epilepsy.
ADS-4101 is being developed as a once-daily, new high-strength lacosamide designed to deliver high concentrations of the medicine during the day when seizures primarily occur.
Seizures seen in epilepsy patients are temporary changes in behavior caused by problems with the electrical and chemical activity of the brain. According to the Epilepsy Foundation based in the United States, nearly 65 million people around the world have epilepsy, and between 2.2 and 3 million people in the U.S. have the condition.
Nearly two-thirds of epilepsy patients have partial onset seizures, which are generated in and affect just one part of the brain – either the whole hemisphere or part of a lobe. Despite advances, nearly one-third of epilepsy patients continue to suffer from seizures.