Lyndra Therapeutics Receives FDA Clearance of Investigational New Drug Application for LYN-014, its Once-Weekly Oral Levomethadone Treatment in Development for Opioid Use Disorder

Lyndra’s LYN-014 Opioid Use Disorder Program is supported by the National Institute on Drug Abuse, part of the National Institutes of Health, as part of the Helping to End Addiction Long-term Initiative

Weekly dosing of levomethadone has the potential to transform opioid addiction management for the 2 million people in the U.S. with opioid use disorder

Lyndra plans to initiate a Phase 1 clinical trial in mid-2021

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for LYN-014, the Company’s oral, ultra-long-acting, extended-release (ER) levomethadone capsule in development for the weekly treatment of opioid use disorder. Lyndra received funding from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, to accelerate the development of this once-weekly levomethadone program.

LYN-014 is designed to address a critical unmet need for people with opioid use disorder and provide consistent target therapeutic levels of levomethadone over the course of an entire week from a single, once-weekly oral capsule. The IND clearance enables Lyndra to initiate a Phase 1 clinical trial in patients currently taking and controlled on daily oral immediate release (IR) methadone. Levomethadone is an enantiomer of racemic methadone approved for use in Europe since the 1960s for pain management and opioid maintenance therapy. Lyndra is planning to request Fast Track Designation for LYN-014 and the Company will explore avenues to accelerate access for U.S. patients in need, working in collaboration with the FDA.

“Providing the 2 million people in the U.S. struggling with opioid use disorder with an opportunity to manage their addiction via weekly dosing instead of daily medication has the potential to not only improve adherence and outcomes, but enable patients to resume basic daily activities while properly managing their disease,” said Dr. Richard Scranton, chief medical officer of Lyndra Therapeutics.¹ “We are grateful for the support of the National Institutes of Health in accelerating these efforts and look forward to progressing this important clinical program.”

About Opioid Use Disorder

Opioid use disorder is a serious national crisis that has major public health implications, affecting approximately 2 million people in the U.S. – numbers which have been even further exacerbated by the ongoing COVID-19 pandemic.¹ According to provisional data from the Centers for Disease Control and Prevention, it is predicted that more than 90,000 drug overdose deaths occurred in the U.S. in the 12 months ending in September 2020 – the highest number of overdose deaths ever recorded in a 12-month period.² While there are a number of evidence-based treatments available for opioid use disorder, these medications are highly regulated, and may require daily patient visits to a specialized clinic to take medication while observed by a medical professional. This strict therapeutic regimen presents significant challenges to ensuring patient access, adherence, and compliance, to these important treatments.

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 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 through funding from the NIH. For more information, visit the Company’s website at www.lyndra.com.

Research reported in this announcement was supported by the National Institute on Drug Abuse through the NIH HEAL Initiative under Award Number UG3DA050310. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.

¹ Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, RTI International. Results from the 2016 National Survey on Drug Use and Health: Detailed Tables. Online: https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm. 2017.

² Centers for Disease Control and Prevention. Provisional Drug Overdose Death Counts. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed May 3, 2021.

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