Sequessome Technology®

Sequessome vesicles are ultra-deformable, hydrophilic spheres made from phospholipid and surfactant molecules arranged as a bilayer. Conventional liposomes form rigid bilayer spheres, but the inclusion of surfactants softens the bilayer membrane making Sequessome vesicles flexible, but also stable, allowing them to pass through the skin intact and penetrate deep into the body without requiring injection or skin permeation enhancers. As the aqueous gel dries out, the vesicles are drawn into the intracellular spaces in the skin driven by the hydration gradient. Conventional (rigid) liposomes require injection.

Sequessome vesicles were originally developed as a carrier to deliver active pharmaceutical ingredients (APIs) transdermally. One of these programmes demonstrated drug-free Sequessome vesicles working as well as an oral NSAID (celecoxib) to treat the symptoms of osteoarthritis in a twelve week trial involving osteoarthritis of the knee – the current FDA and EMA standard for registrational trials.

Using data from this programme together with additional research confirming the unique physical mechanism of action of biolubrication, we have demonstrated that Sequessome vesicles have the ability to address the symptoms of OA in an entirely new way without the use of drugs. This provides a much needed alternative to current approaches, which typically use either non-steroidal anti-inflammatory drugs (NSAIDs) or opioids with a range of serious and potentially fatal side effects, or highly invasive injections directly into the affected joints.

It also offers a treatment that does not interact with medications, the efficacy of which can be compromised by the use of certain commonly used drugs. This is a particular problem for OA sufferers who are at greater risk of co-morbidities, most notably cardio-vascular problems. Sequessome vesicles' safety profile not only benefits the patients but reduces the overall cost of care, an important advantage for healthcare payors

Consequently, Pro Bono Bio launched FLEXISEQ® in Europe in 2012 as the first twice daily topical medical device for treating the symptoms of OA, and the first new class of treatment for osteoarthritic joint pain since the launch of the selective COX2 NSAIDs in 1999.