Depomed, Inc. (NASDAQ:DEPO) today announced that in its Phase 1 pharmacokinetic study in Parkinson’s patients, DM-1992, Depomed’s investigative novel gastric retentive extended-release formulation of levodopa/carbidopa, extended coverage above levodopa’s efficacious threshold and extended the time to peak levodopa concentration relative to currently available sustained release levodopa/carbidopa formulations.
One of Depomed’s formulations in the study extended the median time point at which levodopa blood levels exceeded the efficacious threshold of 300 ng/mL to approximately nine hours, compared to approximately seven hours for the generic version of Sinemet CR tested in the study. The time to median peak levodopa blood levels in the study was extended to four hours, compared to 2.8 hours for the comparator. DM-1992 was well tolerated in the study.
“We are encouraged by the pharmacokinetic results observed in this study, as they indicate that DM-1992 may optimize the absorption of Levodopa in the duodenum, the area of the upper gastrointestinal tract where Levodopa is preferentially absorbed. We have already begun work refining our formulation to optimize how our Acuform technology operates within stomachs of Parkinson’s patients, with a view to achieving a formulation that may be dosed twice daily with consistent efficacy and reduced side effects, which would represent a significant clinical benefit to Parkinson’s patients,” said Dr. Mike Sweeney, vice president research and development of Depomed. “After we complete further formulation work, we anticipate doing another phase I trial to confirm the performance of the formulation before out licensing the program,” added Dr. Sweeney.
“Depomed’s technology was able to significantly extend the duration of plasma levels of levodopa/carbidopa. The Phase 1 clinical data was very encouraging and we look forward to further work to perfect this formulation in the clinic,” added Dr. Igor Stolyarov MD, PhD, Doctor of Medical Sciences, Professor at Institution of Russian Academy of Sciences “Institute of Human Brain of RAS", one of the two principal investigators in the study with Professor Sergey Illarioshkin from St Petersburg.
DM-1992 Phase I Trial Design
DM-1992 is an investigative novel gastric retentive extended-release dosage form of Levodopa/Carbidopa, a marketed therapy used in the treatment of Parkinson’s disease. The Phase I trial in DM-1992 was a randomized, open-label crossover study that enrolled 18 patients with stable Parkinson’s disease at two leading neurology centers in Russia. The objective of the study was to compare the pharmacokinetics of two distinct formulations of DM-1992 and a generic version of Sinemet CR sustained-release Levodopa/Carbidopa, as well as the safety and tolerability of the formulations. Patients in the trial received a single dose of each of the three treatments being studied. A dose of the first treatment was administered at the beginning of the study, followed by a dose of a second treatment after 7 to 14 days, and a dose of the third treatment after another 7 to 14 days. Blood samples were drawn during the 24 hour period following administration of each treatment. Patients remained on any anti-Parkinson’s therapy other than Levodopa/Carbidopa during the trial.
About Parkinson’s disease
Parkinson’s disease is a chronic, degenerative neurological disorder that affects nearly one million Americans, with significant prevalence growth expected over the next 25 years due to aging population demographics. Six million worldwide are estimated to have Parkinson’s. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. Current therapies are effective in addressing only the mild/moderate motor symptoms of the disease and have significant long-term side effects. There are no drugs available that target the numerous non-motor aspects of the disease as well as the underlying degenerative process.