Inion: Bone regrowth technology

Licensing opportunity

Inion, a Finnish biodegradable implants specialist, is looking to partner or outlicense its OptimaPLUS bone regrowth technology after a clinical trial failed to show any improvement over existing products.

The study was designed to evaluate the quality of new bone generated following a dental implant surgical procedure and compared Inion’s OptimaPLUS with a non-biodegradable competitor product, GORE-TEX Regenerative Membrane Titanium Reinforced.

There was no statistically significant difference in bioactivity at the interim stage of the trial when comparing the Inion OptimaPLUS membrane with the GORE-TEX membrane. This is at odds with preclinical studies that have shown that the active ingredient in OptimaPLUS, N-methyl-pyrrolidone (NMP) has the ability to accelerate bone growth.

Inion said that while OptimaPLUS has not performed better in the trial so far, completion of the trial is likely to provide support for the claim that there is no difference in bone growth between the Inion OptimaPLUS membrane and the GORE-TEX membrane.

Chris Lee, CEO of Inion, said, “So far in this trial, Inion OptimaPLUS has performed as well as the GORE-TEX membrane in supporting new bone growth around dental implants, however, we have not seen evidence of bioactivity.”

“Despite this, we still believe that by completing the trial we will be able to add to the product a claim that there is no difference in bone growth when compared to the GORE-TEX membrane, with the added benefit that the Inion OptimaPLUS membrane [being biodegradable] does not need to be removed with a further invasive procedure.”

This is the second setback for the OptimaPLUS technology. Last year another trial had to be stopped when five subjects in the Hong Kong arm of the trial experienced inflammatory responses. Subjects in the control arm experienced the same response, indicating the problem was not caused by the product. But the forced ending of the trial left the company still lacking proof that OptimaPlus can reproduce the accelerated bone growth seen in animal models, in humans.

Last year, Inion underwent a restructuring, closing its R&D lab at Cambridge University, to focus on commercialisation of its products for spinal surgery and orthopaedic trauma. The centre in Cambridge was operating for less than two years but in this time researchers had identified the molecular mode of action of NMP and strengthened the surrounding intellectual property.

The activity of NMP was discovered by chance through another of Inion’s university collaborations, with a group specialising in bone morphogenic proteins at the University of Zurich. NMP was being tested as a plasticiser for improving the handling properties of Inion’s biodegradable polymers, when the unexpected outcome of bone regrowth was detected.

Lee said that given the likely outcome of the OptimaPLUS trial, Inion, “may seek to divest, or search for a strategic partner for the NMP programme and patent portfolio.”