WATERTOWN, Mass.--(BUSINESS WIRE)--Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past with the first-ever ultra-long-acting, sustained release oral therapies, today announced the first subject has been dosed in a Phase 1 clinical trial evaluating LYN-047, the Company’s rosuvastatin extended-release capsule, which is being developed for the weekly oral treatment of dyslipidemia. This Phase 1 open-label study is examining the safety, tolerability and pharmacokinetics of a once-weekly rosuvastatin extended-release capsule (LYN-047) in 16 healthy volunteers in Australia. Following a run-in of immediate release rosuvastatin, participants are receiving the 140 mg capsule (equivalent to a 20 mg daily dose) in two administrations a week apart.
Lyndra’s rosuvastatin extended-release capsule is designed to provide steady and sustained release of the therapeutic into the stomach by gradually eluting the drug from a non-dissolving dosage form that stays in the stomach for approximately one week. This therapeutic design has the potential to enable consistent and steady dosing of medication over a one-week period, as well as to improve medication adherence for patients.
“Statins have served as a first-line treatment for dyslipidemia for a number of years, having demonstrated established clinical benefits and a favorable safety profile. Yet millions of patients do not adhere to the daily oral administration for this important medication and therefore remain at high risk for cardiovascular-related events and even death,” said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. “A once-weekly rosuvastatin has the potential to provide better outcomes for dyslipidemia patients who are not adherent to medication regimes, and we look forward to rapidly advancing this Phase 1 clinical trial.”
Rosuvastatin is an HMG-CoA reductase inhibitor, generally known as a statin or lipid-lowering agent, is currently approved as an immediate release tablet for the daily oral treatment of adults with dyslipidemia and has a well-established and favorable safety and efficacy profile.
Additional information about this clinical trial is available at http://www.anzctr.org.au/.
Dyslipidemia occurs when there are abnormal levels of cholesterol or lipids in the blood. The condition affects more than 136 million people in the United States alone and is a key risk factor in cardiovascular disease – the number one cause of death globally, which takes an estimated 17.9 million lives each year.1,2
About Lyndra Therapeutics
Lyndra Therapeutics is pioneering the first-ever oral, ultra-long-acting, sustained release therapies, which have the potential to fundamentally change the way people take medicine by enabling patients to take a pill once a week rather than daily. The Company’s breakthrough Extended-Release Oral Capsule is designed to provide consistent drug levels for an entire week or as long as a month, from one, normal-sized capsule – something no oral therapy has ever achieved before. Lyndra’s robust pipeline is made up of therapies with established and well-known safety profiles across a number of disease areas in which non-adherence is known to be a significant driver of outcomes, including schizophrenia and other central nervous system diseases, diabetes, cardiovascular disease and opioid abuse disorder, among others. The Company is also committed to advancing its platform across new chemical entities and a variety of critical global and public health opportunities alongside partners such as the Bill & Melinda Gates Foundation and the NIH. For more information, visit the Company’s website at www.lyndra.com.
1 Toth. J Clin Lipidol. 2012; U.N. World Population Prospects; ClearView Analysis.
2 World Health Organization. Cardiovascular Disease. https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1. Accessed Jan. 14, 2021.