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Orexo announces positive Phase I data

Orexo has announced positive results from the first explorative human clinical study for its nasal epinephrine (adrenaline) rescue medication for allergic reactions, OX640.

The study was a comparative bioavailability study performed in 40 healthy volunteers assessing four investigational formulations of OX640 compared to a marketed epinephrine auto-injector.

“The study results are truly exciting, and I am looking forward to the continued development of this important and differentiated product. The data also provides further validation of our drug delivery platform amorphOX and solidifies Orexo as a leader in advancing drug delivery with amorphous formulations and nasal delivery,” commented Robert Rönn, SVP and Head of R&D at Orexo.

A needle-free alternative

All four investigational formulations were extensively absorbed and rapidly achieved clinically relevant plasma levels of epinephrine comparable to the reference product, describes the company in a press release. Furthermore, all four OX640 formulations showed concentration dependent effects on heart rate and blood pressure, a pharmacological response relevant for the treatment of allergic reactions, the company states. Local and systemic safety findings were generally consistent with known effects of epinephrine and there were no findings that raised any safety concerns.

Epinephrine is commonly used for the treatment of allergic reactions, including anaphylaxis. First line treatments today are intramuscular auto-injector products. The market for these products today exceeds a value of USD 2 billion and is expected to show an annual growth of 8-9 percent. In addition to offering superior stability, in terms of both storage temperature ranges and shelf-life, OX640 provides a less bulky, more convenient, and needle-free alternative to products on the market and under development, states the company.

Based on amorphOX

OX640, which is based on Orexos drug delivery platform amorphOX, has a granted patent in Europe securing exclusivity until 2041 and several other patent applications pending approval across the globe, including the US.

“Led by the development of OX124, our rescue medication for opioid overdose, we have continued to develop the amorphOX platform and we are testing it in a wide range of both small and large molecules. With the positive results from the OX640 study, we once again show proof of concept of the excellent bioavailability provided by this scalable platform. The strong clinical and stability data, the global market need and Orexo’s ability to shorten the time to market through our established supply chain, make this product attractive for partners all over the world,” says Nikolaj Sørensen, President and CEO of Orexo.

For pharma products based on the amorphOX drug delivery platform and that go beyond Orexo’s key therapeutic areas within mental illness and substance use disorders, such as OX640, Orexo will seek partnerships for both continued development and commercialization.

Photo of Nikolaj Sørensen: Jenny Öhman/Nordic Life Science