Burlington, Massachusetts-based Flexion Therapeutics, Inc. and Burnaby, British Columbia-based Xenon Pharmaceuticals, Inc. are partnering to provide Flexion with the global rights to develop and commercialize XEN402, a NaV1.7 inhibitor, which is the active ingredient in a novel post-op, pre FDA approval pain drug called FX301.
Xenon’s FX301 delivers XEN402 using a thermosensitive hydrogel which is intended to provide an extended release of the active ingredient XEN402.
Xenon developed FX301 to be used by orthopedic physicians as a peripheral nerve block for control of post-operative pain. Because FX301 delivers XEN402 uses a thermosensitive hydrogel, within minutes after injecting, it transitions from a liquid to a gel, an effect that, the company told OTW, provides local delivery of XEN402 near target nerves for up to a week.
Most interestingly, the selective pharmacology of XEN402 could potentially provide effective pain relief while preserving motor function. If that should ultimately prove to be the case, then it would enable ambulation, more rapid discharge, and early rehabilitation following musculoskeletal surgery.
According to Flexion, “Under the terms of the agreement, Flexion acquired the global rights to the XEN402 program including a broad patent estate as well as the associated non-clinical, clinical and manufacturing components. As consideration for the acquisition, Flexion paid Xenon an upfront payment of $3 million.”
“In addition, Xenon will also be eligible for various CMC, development and regulatory milestone payments of up to $9 million through initiation of a Phase 2 proof of concept clinical trial. Following successful proof of concept, Xenon may be entitled to future clinical development and global regulatory approval milestone payments of up to $40.75 million, commercialization milestone payments of up to $75 million, as well as future sales royalties ranging from mid-single to low-double digit percentages. As part of the agreement, Flexion will assume Xenon’s obligation to pay a low single-digit percentage of sales royalty to Teva Pharmaceuticals International GmbH. Flexion anticipates initiating FX301 clinical trials in 2021.”
Mike Clayman, M.D., chief executive officer and co-founder at Flexion, told OTW, “We believe FX301 represents a potential first-in-class product which may provide up to a week of postop pain relief, and due to the pharmacologic profile of the active molecule, it does so while preserving motor function. FX301 may enable ambulation, rapid discharge, and early rehabilitation following musculoskeletal surgery. This is a true differentiator as typical nerve blocks inhibit motor function.”
“We engaged a broad group of anesthesiologists and orthopedic surgeons as part of our diligence, and a product with the profile of FX301 was highly attractive and one that they suggested they would be excited to employ in their surgical procedures. One leading orthopedic surgeon described this as a potential ‘game changer,’ and we share his excitement and while clinical investigation is needed to determine the efficacy and safety of FX301, we are very excited about its potential.”
