New top-line results from the phase IIb/III Allegro trial of Pfizer Inc.'s once-daily oral JAK3 inhibitor, ritlecitinib, have met the trial's primary efficacy endpoint of improving scalp hair regrowth in patients with alopecia areata vs. placebo. The new data, to be paired with long-term trial results from Pfizer's long-term Allegro-LT study, move the program one step closer to an expected early 2022 NDA filing.
Positive top-line data from Beyondspring Inc.’s phase III study of plinabulin combined with docetaxel to treat second- and third-line non-small-cell lung cancer (NSCLC) compared to docetaxel alone propelled the company value dramatically higher Aug. 4.
Publication this summer of phase II data with Spruce Biosciences Inc.’s CRF1 antagonist, tildacerfont, for classic congenital adrenal hyperplasia (CAH) in the Journal of Clinical Endocrinology and Metabolism (JCEM) highlighted the indication where a handful of players are known to be active.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allegro, Ambrx, Angion, Antibe, Eli Lilly, Evotec, Fate, Jacobio, Janssen, Kiniksa, Lumosa, Lutris, Rhythm, Springworks.
Outlook Therapeutics Inc. CEO Russell Trenary said positive results from the phase III study called Norse Two represent “the final step we need” to proceed with the BLA in the first quarter of next year for an ophthalmic formulation of the VEGF binder bevacizumab to treat wet age-related macular degeneration (AMD).
Because a safety threshold was exceeded in its study of the company’s lead candidate, otenaproxesul, Antibe Therapeutics Inc. said it has placed testing of the anti-inflammatory drug on a required pause.
LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Biogen, Biophytis, Cytokinetics, Flugen, Humanigen, Ionis, Moderna, Novartis, Prometheus, Servier, Zentalis.
LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Astrazeneca, Beigene, Biogen, Cyclo, Enyo, Lilly, Optinose, RDIF, Vaxart.
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