Flexion Therapeutics announced the FDA informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase IIb trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. Flexion has not yet received written notice of the hold, but verbal communication from the FDA indicates it is due to a single occurrence of an infection in the injected knee of a patient in the trial.
“We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation of this event,” said Michael Clayman, M.D., President and CEO of Flexion.
FX006 is a novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA) targeting moderate to severe osteoarthritis pain. Flexion had originally planned on initiating a Phase III study for the drug later this year.
Germany based Merck KGaA is in advanced talks with potential partners interested in its anti-PD-L1 agent and expects to clinch a partnership before the end of the year. The compound belongs to a new class of immuno-oncology drugs designed to harness the body’s immune system to attack cancer cells.
Merck KGaA’s product has been tested in over 500 patients in Phase I trials and may have potential in lung, ovarian, and Merkel skin cancer. As a mid-sized competitor, it has decided to partner the compound. The company is seeking a partnership for global co-development and co-commercialization of their anti-PD-L1. Analysts believe this new field could develop into a market worth tens of billions of dollars in annual sales.
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