R 348 fails Phase II trial for Dry Eye Disease - Rigel
Rigel Pharmaceuticals, Inc. announced that R 348, its ophthalmic JAK/SYK inhibitor, did not meet the primary or secondary endpoints in a recently completed Phase II clinical study in patients with Dry Eye Disease. The endpoints were measured by changes in corneal fluorescein staining, conjunctival staining, tear production and dry eye symptom scores from baseline over 12 weeks of treatment versus placebo. No significant adverse events were reported in the trial. Rigel has decided not to initiate any new studies of R 348 for this indication, but is continuing its Phase II study of dry eye in patients with graft versus host disease (GvHD).
Related news and insights
Sorrento Therapeutics, Inc. announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase IIA randomised, placebo-controlled study of intravenous allogenic adipose-derived mesenchymal stromal cells to treat Post COVID 19 "Long Haul" Pulmonary compromise (NCT04992247).
Amryt presents long-term safety and efficacy data from the open-label extension (OLE) of its global Phase III MPOWERED non-inferiority clinical trial that compared Mycapssa (oral octreotide capsules) to long-acting iSRLs (injectable Somatostatin Receptor Ligands) for maintenance of biochemical response in patients with acromegaly.
UCB, a global biopharmaceutical company, announced positive top-line interim analysis results showing that the Phase III BE MOBILE 1 study met the primary and all ranked secondary endpoints. BE MOBILE 1 is the first study to evaluate the efficacy and safety of Bimzelx (bimekizumab) in adults with active non-radiographic axial spondyloarthritis (nr-axSpA).