Promentis Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders, today announced it has completed Phase 1 single ascending dose and multiple ascending dose studies for its lead compound, SXC-2023. SXC-2023 has demonstrated a compelling profile across a range of non-clinical studies. Promentis is developing SXC-2023 and other compounds that engage System xc-, a central nervous system (CNS) target addressing glutamatergic imbalance and oxidative stress, to treat impulse control disorders, obsessive-compulsive disorder and other neuropsychiatric diseases.
The aim of the Phase 1 studies was to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of SXC-2023. In the first study, single ascending doses were evaluated in six cohorts, with a total of 48 subjects. In the second study, SXC-2023 was administered daily for 14 days within four different dose groups. SXC-2023 proved to be safe and well-tolerated over a wide dose range in healthy volunteers in both the SAD and MAD studies, and demonstrated a very consistent PK profile. There were no significant adverse events and no treatment-related discontinuations in either study.
“We are very pleased with these results, which show SXC-2023 to be very safe and well-tolerated, and to possess a very well-behaved PK profile,” said Dr. Tom Beck, CMO of Promentis. “We believe that the mechanism and excellent safety profile of the drug are consistent with potential applications in a wide variety of impulse control disorders, both as monotherapy and in combination with other treatments. These results reinforce our interest and enthusiasm in SXC-2023 as we look to the near-term commencement of our Phase 2 program.”
Glutamatergic dysfunction is a hallmark feature of many neuropsychiatric indications, including a broad range of impulse control disorders (ICDs), which is Promentis’ initial therapeutic focus. Read the full story here.