Lyndra Therapeutics Takes on Opioid Use Disorder with Long-Acting Oral Dosage Form

NIH Grant Fuels Development of Once-Weekly Oral Buprenorphine

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, the company making daily pills a thing of the past,
today announced it is developing an ultra-long-acting oral treatment for
opioid use disorder with a grant from the National Institutes of Health
(NIH). More than 47,000 Americans died of opioid overdose in 2017 and 2
million more Americans live with addiction to opioids.*

The National Institute on Drug Abuse (NIDA) has called for new treatment
strategies that help address the current opioid crisis, including new
formulations of existing medications to improve treatment access and
adherence. Lyndra’s grant from the NIH covers development of a
once-weekly oral dosage of buprenorphine, an FDA-approved
medication-assisted treatment (MAT) that improves outcomes and saves
lives in patients with opioid use disorder (OUD). No oral buprenorphine
product is currently available.

“The opioid epidemic has taken a heavy toll in the United States, with
more than 130 people dying after overdosing every day. We agree with
NIDA that there is a critical need for innovative, science-based
solutions to treat opioid use disorder and addiction,” said Andrew
Bellinger, co-founder and Chief Scientific Officer of Lyndra
Therapeutics. “We have established that our once-weekly dosage form can
deliver controlled, steady medication. There is a clear indication for
our platform in the treatment of opioid use disorder to provide a more
accessible, effective treatment option for patients.”

“To remedy the national opioid crisis, the NIH is strategically
investing in companies that can put solutions in the hands of clinicians
as soon as possible. With its ultra-long-acting oral delivery system
already in clinical trials, Lyndra is on a timetable that can help the
NIH advance treatment options faster. I’m pleased to see Lyndra receive
this grant,” said Charles O’Keeffe, former President and CEO of Reckitt
Benckiser Pharmaceuticals, the company that developed Suboxone.

The grant is part of the Focused Opioid Use Disorder Medications
Development Research Project under the HEAL (Helping to End Addiction
Long-term) initiative. Lyndra will use the grant for preclinical
development of the once-weekly buprenorphine dosage in 2019 with plans
to begin Investigational New Drug enabling work later this year.

* CDC/NCHS, National Vital Statistics System, Mortality. CDC Wonder,
Atlanta, GA: US Department of Health and Human Services, CDC; 2017. https://wonder.cdc.gov.

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
website www.lyndra.com.

Contacts

Ken DiCienzo
Greenough
[email protected]
781-351-1519