After receiving results from the PKstudy with Empli03, Emplicure is now moving forward with the formulation development of the candidate. The company also recently initiated a collaboration with OnDosis to develop better pain treatments. BioStock talked to CEO Håkan Engqvist.
Uppsala company Emplicure works with two parallel main tracks, pain medicines and nicotine products. The subsidiary Emplipharm develops new drugs for patients with chronic pain by combining approved drug substances with the company’s patented bioceramic platform. By doing so, the company hopes to create new and improved drugs with properties such as tailor-made release profiles. The subsidiary Amplicon develops nicotine products for the consumer market.
PK study shows steady profile
Emplicure recently announced that they are moving forward with formulation development to boost the initial release profile of buprenorphine in Empli03. The news comes after study results from the exploratory pharmacokinetic (PK) study conducted last year showed a steady extended release profile.
Empli03 is an oral buccal tablet with the opioid buprenorphine and is to be used by patients with moderate to severe chronic pain. Buprenorphine is approved for the treatment of opioid use disorder and pain in both the US and the EU.
The purpose of the PKstudy was to document the safety profile of Empli03 and the pharmacokinetic properties of the drug in humans. Twelve healthy volunteers were dosed with an oral buccal tablet placed under the upper lip for six hours. Throughout the study, blood samples were collected, and all subjects completed the study. No local irritation was observed.
“The results show that our ceramic platform is a powerful tool for controlled release of buprenorphine. This gives us confidence to proceed with the development of the formulation to increase the initial release profile. We believe that Empli03 can play an important role in the treatment of moderate to severe chronic pain and possibly also opioid drug dependence”, CEO Håkan Engqvist states in a press release.
Collaboration with OnDosis
Emplicure has also announced that they are collaborating with OnDosis to develop better pain treatments. OnDosis, which was founded as a spin-out from AstraZeneca in 2017, is a Swedish company focused on personalised dosing of drugs.
The two companies will evaluate common development goals for oral dosing of active ingredients based on the companies’ respective core competencies in formulation and dosage.
CEO comments on the results
BioStock spoke to Emplicure’s CEO Håkan Engqvist about the results of the PK study and the future plans.
If we start with the PK study, you state that the results show that the platform is “a powerful tool for controlled release of buprenorphine”. Can you elaborate a bit on what this means?
– The results show that our formulation in Empli03 provides a slow release of buprenorphine in plasma. This is a clear proof that we can achieve controlled release with a formulation developed from our platform.
If we interpret you correctly, the dose of buprenorphine needs to be increased at an initial stage to achievethe desired effect. Is that correct?
– We will now focus on the initial release rate, so that we can obtain a faster effect of the buprenorphine, not necessarily increase the dose of buprenorphine.
Your candidate is developed to achieve a long-term release. What were the results regarding the longer-term release in the study?
– Yes, exactly, and the results show that our formulation gives a slow release of buprenorphine in plasma.
Does this mean that you will need to carry out a new study with the further developed formulation?
– The purpose of exploratory studies is precisely to produce more information about the product and is always followed by further regulatory studies, this will also be the case in this instance.
Turning to the collaboration with OnDosis, can you tell us more about it and what you hope it will result in?
– Together with OnDosis, we will evaluate potential formulations for individualised oral dosing of opioids. The collaboration is based on our respective core competencies in formulation and dosage and will enable our joint pursuit of the development of safer medication.
What role does the collaboration play in the further development of Empli03?
– The collaboration is a new project in our drug portfolio, in addition to Empli03, and is an important part of Emplicure’s vision to contribute to a safer pain treatment. Prescription opioid abuse is often the starting point for lifelong addiction and there is an urgent need for several different measures to prevent both addiction and overdosing. In Emplipharm, we do this through the development of formulations that makes misuse more difficult , individualised dosing and by increasing the availability of buprenorphine, a partial agonist with a favourable safety profile.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.