​Morrisville-based Liquidia Technologies has reported positive initial results from a phase 1 clinical trial of a drug candidate for relieving post-surgery pain as an alternative to addictive opioids.

The drug-delivery company said topline data indicated that the compound, called LIQ865, was well tolerated and had an effect consistent with a local anesthetic effect lasting for three or more days. The study, conducted in Copenhagen, Denmark, evaluated the safety and activity of LIQ865 injections in 28 healthy adult male volunteers.

The drug candidate is a potential alternative to opioids for post-surgical pain relief. About 2.1 million people in the United States suffer from substance-abuse disorders related to opioid pain relievers used after surgery, according to the National Institute on Drug Abuse.

“Our intent with LIQ865 is to increase the options for long-lasting, safe, effective post-operative pain relief that can reduce the need for opioids in the early days following surgery,” said Mike Royal, M.D., program leader for the drug and senior vice president for clinical development at Liquidia.

Liquidia said it is developing LIQ865 with the goal of providing at least three days of post-surgical pain relief with a single administration, potentially minimizing or avoiding the need for opioid analgesics.

More than 80 million inpatient and outpatient surgeries are performed every year, with most requiring opioids to treat moderate to severe post-operative pain, the company said. A minority of these patients will become long-term users and have the potential for opioid misuse and addiction.

LIQ865 is a sustained-delivery formulation of bupivacaine, a generic prescription anesthetic that has been on the market for decades. The novel formulation was developed with Liquidia’s proprietary PRINT technology, which combines aspects of biology, medicinal chemistry and polymer science to allow for the precise engineering of drug particles in various compositions, sizes and shapes.

“The phase 1 clinical trial results for LIQ865 further validate the remarkably broad applicability of the PRINT technology across virtually any therapeutic area,” said Neal Fowler, Chief Executive Officer at Liquidia. “We look forward to providing additional updates on our PRINT technology-enabled clinical programs throughout 2017.”

Liquidia is developing other PRINT-enabled drug candidates for the treatment of inhaled diseases, and a spin-off company, Envisia Therapeutics, is developing a treatment for glaucoma. Liquidia is also partnering with other companies including GlaxoSmithKline on additional applications.

The company says the PRINT technology, which draws on production methods used in the semiconductor and materials industries, “overcomes conventional formulation and production constraints to improve the efficacy, safety, and convenience of a wide range of medicines, while reducing manufacturing complexity and cost.”

The North Carolina Biotechnology Center has supported Liquidia by providing a two-year industrial fellowship in 2012 that allowed postdoctoral researcher Katie Horvath, Ph.D., to work for the company. She is now a senior scientist there.

Privately held Liquidia was spun out of the University of North Carolina at Chapel Hill in 2004 by scientists/entrepreneurs Joe DeSimone and Ed Samulski. It has since gained equity investments from heavy-hitters including the Bill and Melinda Gates Foundation, GSK, PPD, Pappas Ventures, Morningside Group, Wakefield Group, Canaan Partners and New Enterprise Associates.

(C) N.C. Biotechnology Center