CS-1103

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, Mass., Sept. 10, 2024 /PRNewswire/ -- 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

From left to right: moderator, Michael Peel, Science editor at Financial Times; John O’Brien, president and CEO of National Pharmaceutical Council; Sarah Emond, president and CEO of Institute for Clinical and Economic Review. Credits: Justine Ra/GlobalData. While innovation has continued to advance with the arrival of CRISPR-based gene therapies and the boom of GLP-1 agonists , the sometimes unsustainable and unaffordable nature of drugs is tipping the balance within the drug development and marketing ecosystem, two experts at the Financial Times Live US Pharma and Biotech Summit said. Both were speaking at a panel on the problems of US drug pricing at the conference, which took place on 16 May in New York. There is a disconnect between benefits and expenditure such that healthcare spending is slowly occupying increasing portions of employer budgets without people seeing the commensurate impacts or increases in life expectancy in return, said Sarah Emond, president and CEO of Institute for Clinical and Economic Review. The affordability of drugs has been an ongoing concern, and when solutions originating from comprehensive discussions about balancing innovation signals with affordability are not brought to the table, the result is a “blunt force trauma” solution such as the Inflation Reduction Act (IRA) , she said. What the ecosystem needs is a transparent way of assessing value that brings stakeholders together, Emond said. Pharma has thought about value for a very long time and even more so as the conversation has moved into a debate about drug pricing, added president and CEO of National Pharmaceutical Council John O’Brien. However, the ambiguity of defining and measuring value has made it difficult to establish a meter for it, he elaborated. The concern with the IRA is that the conversation about drug value and pricing is taking place in a system with “perverse incentives” and with a primarily fiscal and economic valuation mindset, said O’Brien. See Also: CS-1103 by Clear Scientific for Substance (Drug) Abuse: Likelihood of Approval Trastuzumab rezetecan by Jiangsu Hengrui Medicine for Colorectal Cancer: Likelihood of Approval Emond explained how in addition to the “disaggregated” market in the US that sees a mix of hundreds of commercial, employer, taxpayer, and government payers, the system has masked the true cost of healthcare. She went on to say reformed accessibility begins with the de-escalation of the “arms race” that sees increased drug prices and higher rebates. “I would like to see a system that chooses and makes accessible medicines based on the benefits that they provide as opposed to the market that can be extracted,” said O’Brien.