- The Phase 1 study for CS-1103 met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse events
- Phase 2 studies for the treatment of methamphetamine and fentanyl overdose are planned for early 2025
CAMBRIDGE, MA, USA I September 10, 2024 I Clear Scientific, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for conditions and diseases caused by an excess of harmful substances in the body, today announced positive topline data from the First-in-Human Phase 1 clinical trial of its therapeutic CS-1103 that demonstrate a favorable safety and tolerability profile.
All thirty-two healthy participants recruited, divided into 4 cohorts, completed the Phase 1 single ascending dose, randomized, double-blinded, placebo-controlled, safety, tolerability and pharmacokinetics study. In this study, single doses of CS-1103, administered via intravenous injection, were well tolerated. There were no serious adverse events reported.
The Phase 1 study supports the dose requirement for the Phase 2 studies on meth and fentanyl overdose, planned for early 2025.
“The phase 1 results clear a critical hurdle, as together with the pre-clinical studies, convincingly demonstrate both safety and efficacy of CS-1103. Based on these strong results, we are working toward an accelerated registration pathway with Phase 2 studies to begin in early 2025. We thank the National Institute on Drug Abuse (NIDA) of the NIH for their continued support,” said Shekar Shetty, Clear Scientific CEO.
About the Overdose Epidemic
The US overdose crisis continues unabated, with 1.9M emergency department (ED) visits and over 100,000 deaths annually.
According to the CDC, drug overdose mortality rates are at the highest level they’ve ever been, and overdose is the leading cause of death for Americans under the age of 50. There are currently approved medications for opioid overdose, however, there are no approved treatments for overdose with stimulants or overdoses that result from drug combinations.
About CS-1103
CS-1103 is a first-in-class injectable small molecule sequestrant that immediately binds to and inactivates target compounds, rapidly reversing their toxic effects and accelerating clearance into urine. Clear Scientific is developing CS-1103 for treatment of overdose and selected metabolic, central nervous system, and neurodegenerative disorders.
About Clear Scientific
Clear Scientific, a clinical-stage biopharmaceutical company co-founded by George Whitesides of Harvard University, is pioneering a new paradigm for treatment of conditions and diseases that involve an excess of specific compounds in the body. This approach focuses on development of highly selective, small molecule sequestrants that bind, immediately inactivate, and rapidly clear excess compounds from the body.
Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA053054. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
SOURCE: Clear Scientific
Post Views: 2,119
- The Phase 1 study for CS-1103 met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse events
- Phase 2 studies for the treatment of methamphetamine and fentanyl overdose are planned for early 2025
CAMBRIDGE, MA, USA I September 10, 2024 I Clear Scientific, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for conditions and diseases caused by an excess of harmful substances in the body, today announced positive topline data from the First-in-Human Phase 1 clinical trial of its therapeutic CS-1103 that demonstrate a favorable safety and tolerability profile.
All thirty-two healthy participants recruited, divided into 4 cohorts, completed the Phase 1 single ascending dose, randomized, double-blinded, placebo-controlled, safety, tolerability and pharmacokinetics study. In this study, single doses of CS-1103, administered via intravenous injection, were well tolerated. There were no serious adverse events reported.
The Phase 1 study supports the dose requirement for the Phase 2 studies on meth and fentanyl overdose, planned for early 2025.
“The phase 1 results clear a critical hurdle, as together with the pre-clinical studies, convincingly demonstrate both safety and efficacy of CS-1103. Based on these strong results, we are working toward an accelerated registration pathway with Phase 2 studies to begin in early 2025. We thank the National Institute on Drug Abuse (NIDA) of the NIH for their continued support,” said Shekar Shetty, Clear Scientific CEO.
About the Overdose Epidemic
The US overdose crisis continues unabated, with 1.9M emergency department (ED) visits and over 100,000 deaths annually.
According to the CDC, drug overdose mortality rates are at the highest level they’ve ever been, and overdose is the leading cause of death for Americans under the age of 50. There are currently approved medications for opioid overdose, however, there are no approved treatments for overdose with stimulants or overdoses that result from drug combinations.
About CS-1103
CS-1103 is a first-in-class injectable small molecule sequestrant that immediately binds to and inactivates target compounds, rapidly reversing their toxic effects and accelerating clearance into urine. Clear Scientific is developing CS-1103 for treatment of overdose and selected metabolic, central nervous system, and neurodegenerative disorders.
About Clear Scientific
Clear Scientific, a clinical-stage biopharmaceutical company co-founded by George Whitesides of Harvard University, is pioneering a new paradigm for treatment of conditions and diseases that involve an excess of specific compounds in the body. This approach focuses on development of highly selective, small molecule sequestrants that bind, immediately inactivate, and rapidly clear excess compounds from the body.
Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA053054. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
SOURCE: Clear Scientific
Post Views: 2,119
