Emplicure AB and Quotient Sciences Announce an Integrated Manufacturing and Clinical Testing Partnership for Emplicure’s First Clinical Pharmacokinetic Study for EMPLI03

On November 29, 2022 Quotient Sciences, a global drug development and manufacturing accelerator, reported a partnership with Emplicure, a Swedish pharmaceutical company focused on chronic pain and abuse-deterrent formulations (Press release, Quotient Sciences, NOV 29, 2022, View Source [SID1234624569]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The partnership will see Quotient Sciences support the GMP manufacture and first clinical pharmacokinetic (PK) study for EMPLI03 using its unique Translational Pharmaceutics platform.

Emplicure is developing EMPLI03 as an oral buccal tablet with extended-release properties intended for the treatment of moderate to severe pain. The formulation is also designed to limit the potential for manipulation of the tablet for abuse.

Quotient Sciences’ integrated Translational Pharmaceutics platform has been used to establish the GMP manufacturing process for EMPLI03 and to perform the first clinical PK study. Dosing in the PK study has been successfully completed, and top-line data will be available at the beginning of 2023.

"We have achieved one of our milestones in the development of a Buprenorphine product for the treatment of moderate to severe pain. With properties that limit abuse, EMPLI03 may contribute to a safer medical treatment", said Håkan Engqvist, CEO of Emplicure.

Mark Egerton, PhD, CEO of Quotient Sciences, added, "We are delighted to partner with Emplicure on the development of a potential treatment for moderate to severe pain. Using our unique Translational Pharmaceutics platform, the GMP manufacturing and first PK study for EMPLI03 has been fully integrated, which is a proven approach to accelerate development timelines."

Quotient Sciences introduced its Translational Pharmaceutics platform in 2008 as a fully integrated drug development and clinical testing platform.

The platform integrates drug substance, drug product, and clinical testing activities under one organization to break down industry silos and accelerate molecules through development.