WATERTOWN, Mass.--(BUSINESS WIRE)--Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s lead product candidate for once-weekly treatment of schizophrenia. The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.
Lyndra and the FDA aligned on key elements of Lyndra’s pivotal program: a ~90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of risperidone and a double-blind safety study of 6 months’ duration to characterize the safety profile of the Lyndra dosage form. Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily. These studies will support indications in schizophrenia, bipolar mania, and bipolar 1 disorder.
“We are grateful to the FDA for their guidance as we design this pivotal program. Transforming the patient experience via oral therapies that achieve consistent plasma drug concentrations at target therapeutic levels for an entire week is one of our key goals,” said Dr. Patricia Hurter, Chief Executive Officer of Lyndra Therapeutics. “This pivotal program allows us to deliver swiftly on the unmet need for ultra-long-acting oral therapies that have the potential to have an enormous and positive impact for patients and caregivers. We hope that the availability of an oral, once-weekly risperidone product will provide a valuable option for those who struggle with adherence but prefer an oral formulation.”
The June EOP2 meeting was attended by FDA staff from the Center for Drug Evaluation and Research, including the Emerging Technology Team, and the divisions of Psychiatry, Pharmacology and Toxicology for Neuroscience, and Regulatory Operations for Neuroscience.
“The FDA provided valuable feedback during the end-of-phase 2 meeting on trial design, manufacturing and control strategy and Lyndra’s path forward as we pursue the pivotal program,” said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. “The productive and collaborative nature of these meetings has allowed us to develop a clear and direct course of action as we pursue the tremendous potential of LYN-005.”
Advancement of LYN-005 into pivotal trials and the company’s preparation for commercialization in the U.S. are enabled by the recent closing of Lyndra’s $60.5 million Series C financing. The round was led by new investor AIG Investments, an affiliate of American International Group, Inc. Since inception, Lyndra has received $240 million in funding, inclusive of this round.
LYN-005, Lyndra’s oral, ultra-long-acting extended-release weekly risperidone capsule, which is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder, is the company’s lead product candidate. LYN-005 uses Lyndra’s innovative extended-release oral capsule technology to provide doses ranging from 2 to 6 mg of risperidone daily, over one week with a single dose. The capsule is expected to achieve this through a first-of-its-kind design that will provide extended gastric residence, controlled, steady drug release and timely passage through the gastrointestinal tract. Phase 2 data for LYN-005 demonstrated that the active moiety quickly reached therapeutic levels in patients, provided sustained drug levels for repeated one-week dosing intervals and reduced peak drug exposure. LYN-005 has the potential to be the first-ever ultra-long-acting oral therapy for the treatment of people with schizophrenia, a disorder for which non-adherence rates are estimated to be around 50%.
Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects more than 2 million U.S. adults, often beginning in the late teens or early twenties. The disease typically manifests as hallucinations, delusions and disorganized thoughts and behavior. Estimated non-adherence rates in schizophrenia are about 50%. Medication non-adherence, the most common risk factor for relapse in patients with schizophrenia, can be improved with the use of longer acting formulations of antipsychotic drugs. Daily risperidone has well-established efficacy and safety when taken as prescribed. Studies have shown that long-acting injectables improve adherence and outcomes among those who are unable to comply with daily regimens. LYN-005 provides an oral, long-acting alternative that may be preferred by some patients and caregivers.
About Bipolar Disorder
Bipolar disorder is a mental health condition characterized by episodes of severe mood disturbances. Approximately 4.4% of U.S. adults are estimated to have bipolar disorder at some point during their lives, with causes including genetics, brain abnormalities and environmental factors. Bipolar I, one of two main types of the disorder, involves periods of severe mania and depression.
About Lyndra Therapeutics
Lyndra Therapeutics is pioneering the first-ever oral, ultra-long-acting, extended-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, oral contraception and opioid use 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.