Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia

Data demonstrate LYN-005 quickly reaches therapeutic levels in patients, provides sustained risperidone drug levels for repeat one-week dosing intervals and reduces peak drug exposure

Lyndra plans to meet with the U.S. Food and Drug Administration to discuss clinical path and pivotal clinical trial design

Investigational product in development has potential to improve compliance and adherence for people with schizophrenia or schizoaffective disorder

WATERTOWN, Mass.--(BUSINESS WIRE)--Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced results from its Phase 2 study of LYN-005, the Company’s oral, ultra-long-acting, extended-release (ER) risperidone capsule, in development for the weekly treatment of schizophrenia. These data, from the Company’s first repeat dose Phase 2 study in patients, demonstrate that LYN-005 provided sustained therapeutic levels of risperidone over the one-week dosing intervals and reduced peak drug exposure relative to immediate release (IR) risperidone.

Results from the clinical trial will be presented in an oral presentation at the 2021 Congress of the Schizophrenia International Research Society (SIRS), today, Sunday, April 18, 2021.

“Of the 2.2 million people suffering from schizophrenia in the U.S., approximately 50% of those receiving treatment may be non-adherent within the first year of treatment, and a majority will relapse within the first five years of receiving that treatment. Preventing relapse is important in reducing overall healthcare costs and in preserving functioning in individuals with schizophrenia,” said Dr. David Walling, chief clinical officer at Apex Innovative Sciences, chief executive officer and principal investigator of CNS Research and study presenter at SIRS. "These data are very promising as, in addition to improving adherence, weekly oral risperidone treatment may provide more consistent plasma drug levels than daily dosing.”

“These data, along with additional safety data from more than 200 administrations of the Lyndra ER capsule from 10 studies, add to our momentum as we move down the development pathway with plans to conduct our end of Phase 2 meeting with the FDA this summer and initiate a pivotal study of LYN-005 in schizophrenia in the second half of this year,” said Dr. Richard Scranton, chief medical officer of Lyndra Therapeutics. “We look forward to demonstrating the unique clinical value a novel treatment option like LYN-005 could have for people with schizophrenia or schizoaffective disorder as we work to reinforce the broad potential of Lyndra’s breakthrough oral medication platform to address medication non-adherence across a variety of important disease areas.”

About LYN-005 Phase 2 Study

The Phase 2 multiple-dose, randomized, parallel group, placebo-controlled study assessed the safety, tolerability and pharmacokinetics of Lyndra’s ER risperidone capsule in 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder. Although treatment assignment was blinded, the dose level was not blinded. The study included a lead-in period in which patients received IR risperidone tablets (2 mg or 4 mg) for 13 days in order to achieve a steady therapeutic state. Following the lead-in, patients were randomized 3:1 to receive weekly Lyndra ER risperidone capsules (14 mg or 28 mg) with daily IR risperidone-matched placebo or daily IR risperidone (2 mg or 4 mg) with weekly ER risperidone matched placebo for three weeks. The primary endpoints were incidence of treatment emergent adverse events and plasma concentrations of active moiety after repeat doses of LYN-005, relative to IR risperidone.

About Schizophrenia

Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects approximately 2.2 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. 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.

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.