Uppsala-based Emplicure kicks off the autumn term by advancing their main project Empli03. On Tuesday last week, British authorities approved the company’s application to conduct a clinical pharmacokinetic study with the candidate. BioStock asked Emplicure’s CEO Torbjörn W. Larsson what the announcement means for the company and what the next step in the project is.

Emplicure’s leading drug candidate Empli03 is being developed for the treatment of chronic pain. The candidate is based on Emplicure’s patented bioceramic platform technology, which is combined with approved drug substances to create new and improved drugs. One of the main advantages of Emplicure’s candidate is the tailor-made release profile that is acheived using the platform technology, in Empli03’s case the Emplior platform. In the case of Empli03, a buccal tablet, the company’s bioceramic material is combined with the opioid buprenorphine to treat chronic pain. The tailor-made release profile is designed to meet the medical need that exists between immediate-release pain medications and long-acting patches. Furthermore, Empli03 has properties that make abuse more difficult.

Empli03 advances towards PK study

One of the main milestones of 2022 for Emplicure is a clinical pharmacokinetic (PK) study with Empli03. It is the first clinical study with Empli03 and the company has now taken a significant step closer to the initiation of the study through the approval by the British authorities. The study aims to document the safety profile and pharmacokinetic properties of the candidate in humans. In addition, the study will provide Emplicure with important information for the continued development and strengthen knowledge about the company’s platform technology.

Initial results towards the end of the year

In December 2021, Emplicure signed an agreement with the British contract research organisation (CRO) Quotient Sciences which will also conduct the study. The approval of the PK study means that Quotient Sciences is now initiating recruitment and screening of study participants. A total of 12 healthy volunteers will be dosed with one tablet and the blood concentration of the active substance will be measured. According to the company, it expects to have initial results from the study towards the end of 2022.

CEO comments

BioStock asked Emplicure’s CEO Torbjörn W. Larsson to comment on the positive study announcement and took the opportunity to ask what is next for Empli03.

Torbjörn, with the approval in place, when do you expect the first subject to be dosed and how long is the PK study expected to run for?

– Quotient has now started the recruitment of healthy volunteers and will screen them to determine that they meet all the criteria to be eligible for participation in the study. The clinical part of the study is relatively short but generates a lot of data to be interpreted and analysed before we get results towards the end of the year.

Can you elaborate on what the study results will mean for your continued work with Empli03?

– Study results with clinical data give us important knowledge about both the pharmacokinetics and tolerance of Empli03. We will also obtain information about the Emplior platform, which is important for the continued product development of our product portfolio.

Once the study is completed, what will be the next step in the development of Empli03?

– We continue the development towards a finished product. The study results provide important data for both the continued development of Empli03 and the ongoing work on regulatory strategy primarily aimed for the US market.

– We are planning for a short clinical development program with a bioequivalence study as a key study. In parallel with this, work is underway to find a partner for outlicensing and /or co-development.