LONDON – Dutch startup Enzyre BV is teaming up with Takeda Pharmaceutical Co. Ltd. to complete development of a home diagnostic device that aims to make it as easy for hemophiliacs to self-test their coagulation status as it is for diabetics to monitor their blood sugar levels.

Under the terms of the agreement Takeda will fund Enzyre to complete development of the device, called Enzypad, and will then be responsible for commercialization.

Nijmegen, Netherlands-based Enzyre retains rights to the technology and will be free to commercialize it in other indications, such as emergency medicine and in monitoring patients who are taking anticoagulants to reduce the risk of heart attack and stroke.

“Takeda takes on commercialization in haemophilia A, and that’s really where the value is for us,” said Dirk Pollet, Enzyre CEO. “We think we can develop a commercial product but bringing it to market on a worldwide basis is daunting for a small company like Enzyre,” he told BioWorld MedTech.

Deal comes at opportune time

The deal comes at an opportune time, with Enzyre in the midst of raising a €10 million (US$11.1 million) series A. Pollet said there is interest in investing in the company and he hopes to close the round early next year.

The individual elements of Enzypad are completed and Pollet said it is now “an engineering job” to integrate them. It is expected the device will be ready for market in the second half of 2021.

The agreement follows a request for proposals from Takeda earlier in 2019, inviting companies to propose methods for home coagulation status testing. The diagnostic will support Takeda’s injected Factor VIII replacement Advate (human coagulation Factor VIII) and the extended half-life formulation Adynovate (pegylated antihemophilic Factor), both of which it acquired when it bought rare diseases specialist Shire plc at the start of 2019.

The half-life of Factor VIII varies from one patient to another, and home testing would be relevant to patients being treated with other Factor VIII products, Pollet noted. “All hemophilia patients would probably like to have access and we are working with Takeda to see how to do that,” he said.

How Enzypad works

Enzypad consists of a painless blood sampling device and a single use microfluidic cartridge containing all the reagents that slots into a hand-held processor to enable reagent flow and record the test result. The processor is controlled by a mobile phone app, via which readouts can be uploaded to the patient’s physician.

The processor measures bioluminescence given off by proprietary luciferin-coated peptides when they are broken down specific enzymes in the coagulation cascade. Enzymatic activity is directly proportional to the number of photons generated in the cartridge, which are counted using optical sensors.

Each test requires less than 100 microliters of blood.

Whilst Enzyre is focusing on applying the technology in indications relating to blood coagulation, it could be adapted to measure all types of enzymatic reactions. Pollet said the company expects to license the rights to other applications.

According to Pollet, there are no marketed tests for patients to assess their coagulation status at home. The frequency of attending a medical center for testing depends on the age of the patient, with very young infants who have the inherited disorder being measured several times a week, while adults typically get tested every couple of weeks.

“As [patients] get older and get better understanding of the disease, they [are tested] far less. We think our device will be used more for children,” said Pollet. In the case of small children, being able to monitor coagulation status at home will give carergivers peace of mind. “They fall on a regular basis; their chances of injury are a lot higher,” he said.

There also will be benefits for adult patients in being able to carry out their own risk assessments, for example, if they plan to take part in a sport or other physical activity. “They will be able to manage the condition far better. [Adult patients] are constantly concerned, not just about big bleeds, but microbleeds in the joints,” said Pollet. These can lead to irreversible joint damage.

The technology underpinning Enzyre originated at the Radboud University Medical Center. Pollet said the company has worked with patients’ groups and has a hemophilia A patient on its staff. “We are really coming from the medical need. This wasn’t about developing a technology and then looking for a disease,” said Pollet.

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