“As we set out to show with this study, preliminary data demonstrate predictable pharmacokinetics over seven days in healthy subjects,” said Andrew Bellinger, co-founder and Chief Scientific Officer of Lyndra Therapeutics. “These positive results will accelerate our path toward commercialization, starting with our planned IND for schizophrenia in 2019 and targeting Phase II trials the following year.”
Lyndra anticipates moving multiple drug candidates, including its own therapies as well as drugs commercialized with partners, through Phase I, II and III clinical trials. Lyndra’s strategy to accelerate approval and commercialization of drugs starts with diseases such as Alzheimer’s and schizophrenia where unmet need is well-documented and potential for near-term patient impacts and health system cost reduction is greatest.
“Non-adherence to prescribed medications is a global epidemic, and this led us to start asking ‘what if we stopped trying to change people and changed the pill instead,’” said Amy Schulman, CEO of Lyndra Therapeutics. “And that is exactly what we are working on—with these early positive results we can focus on making medicines that reduce the burden of the daily pill, starting with Alzheimer’s Disease and schizophrenia.”
PK Study Summary
Lyndra’s open-label, single-dose study included eight healthy volunteers to evaluate the safety and tolerability of the extended release prototype containing 50 mg of memantine hydrochloride. An assessment of the PK profile and gastric-retentive properties of the dosage form showed comparability to commercially available Namenda XR historical data with consistent results and no evidence of burst release. All subjects completed the study and overall the Lyndra extended release dosage form was well-tolerated with generally mild adverse events (AEs) that were transient.
About Lyndra Therapeutics’ Platform
Lyndra Therapeutics’ orally administered dosage form is designed to deliver sustained, steady-state release of one or more drugs for up to a week or longer while temporarily residing in the stomach. Taking a single, long-acting pill weekly instead of daily or more often can improve medication adherence and health outcomes while reducing burdens on individuals and their caregivers. Inside a familiar capsule is a star-shaped formulation with active pharmaceutical ingredients that are released consistently over time. The formulation, which is designed to open once inside the stomach, eventually exits safely via the gastrointestinal tract, like undigested food.
About Lyndra Therapeutics
Lyndra Therapeutics aims to improve healthcare outcomes through oral, ultra-long-acting, sustained-release therapies that change how people take medicines. Instead of taking medications daily or more frequently, doses would be administered weekly or monthly, improving medication adherence for better health outcomes and lower healthcare costs. Delivering controlled amounts of medicine would also reduce side effects and improve drug efficacy. For more information, visit the company’s new website www.lyndra.com.