Lyndra Therapeutics Files IND, Bolsters Leadership Team and Readies for Manufacturing

– IND is for ultra-long-acting oral therapy to treat schizophrenia –

– Dr. Richard Scranton named Chief Medical Officer –

– First manufacturing site in Lexington, Mass. scheduled to open in early 2020 –

WATERTOWN, Mass.–(BUSINESS WIRE)–#IND–Lyndra Therapeutics, the company making daily pills a thing of the past, has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) for its ultra-long-acting oral therapy to treat schizophrenia (risperidone). To oversee progress of the new IND as well as multiple Phase I and Phase II clinical trials in 2020 and beyond, the company named Dr. Richard Scranton as Chief Medical Officer (CMO).

“This is a pivotal year for Lyndra that will see us hit critical milestones on our timeline and move much closer to achieving the promise of our ultra-long-acting therapy platform,” said Lyndra CEO Dr. Patricia Hurter. “We now have multiple clinical trials underway and plan to initiate a Phase II trial mid-year. Dr. Scranton’s arrival is well timed given his unique multi-disease platform experience, expertise in opioid-sparing pain therapies and successful track record with the FDA.”

Dr. Richard Scranton joins Lyndra from Pacira Pharmaceuticals, where he served as CMO. During his tenure at Pacira, Dr. Scranton successfully redesigned the company’s clinical trials process and oversaw clinical research and development, leading to the acceleration of several pipeline candidates as well as approval of expanded indications for Pacira’s lead product.

Dr. Scranton has experience designing innovative clinical trials and executing clinical research across all phases of drug/device development, including pharmacoepidemiologic, pharmacoeconomic and patient reported outcomes. His previous work led to approval of a first-in-class diabetes treatment and supportive studies across multiple therapeutic areas. Dr. Scranton has a Master’s in Public Health from the Harvard T.H. Chan School of Public Health and an M.D. from the Quillen College of Medicine at East Tennessee State University. He completed his residency in the U.S. Navy.

“I was drawn in by Lyndra’s mission, especially its commitment to changing the pill to improve the lives of patients and drive greater value in healthcare,” said Dr. Scranton. “I am especially excited about Lyndra’s innovative platform approach and our unique opportunity to transform adherence and outcomes across multiple diseases on a global scale.”

Lyndra also announced that it has selected a site in Lexington, Mass. for its first manufacturing site, which will supply clinical materials for later development and enable manufacturing scale-up. The new GMP-compliant site is scheduled to begin operations in the first half of 2020 and will feature robotics and other innovative manufacturing techniques.

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