As Merck & Co. Inc.’s whopper proposal to take over Prometheus Biosciences Inc. for $10.8 billion faded from the ever-churning headlines, officials of the pharma heavyweight set about answering questions with regard to plans for the newly gained PRA-023, a humanized monoclonal antibody that targets tumor necrosis factor-like ligand 1A (TL1A).
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
Human Immunology Biosciences Inc. (Hi-Bio) is moving ahead to late-stage work after disclosing positive phase II data from two trials testing the monoclonal antibody felzartamab for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. CEO Travis Murdoch told BioWorld that his firm is “working through designs for the next study, and planning to engage with regulators,” after which more details will be shared. PMN, he added, has “not been heavily trodden, but increasingly there’s a recognition that there’s an important patient and commercial opportunity” in the indication.
Word recently from Nexcella Inc. of progress in its potentially BLA-enabling phase Ib/IIa study, with the BCMA-targeted, autologous CAR T therapy called NXC-201 for relapsed/refractory (r/r) multiple myeloma and r/r amyloid light chain amyloidosis, helped put nearer to center stage the class, which has proven attractive to a handful of developers. Among others in the space are Arcellx Inc. and Gracell Biotechnologies Inc.
Centessa Pharmaceuticals plc’s launch of a phase I/IIa trial with LB-101, a PD-L1xCD47 candidate that emerged from the Lockbody platform, highlighted the firm’s efforts against solid tumors. But the diversified company has more in the works, including a registrational study with subcutaneous (subcu) Serpinpc, designed to treat hemophilia (hemo) B. Centessa has a program in narcolepsy, too.
The advance of antifungals – a class long needful of new therapies – continued with Scynexis Inc.’s potential $593 million exclusive license agreement with GSK plc for Brexafemme (ibrexafungerp), first cleared by the U.S. FDA in June 2021 and indicated for vulvovaginal candidiasis (VVC) as well as for reduction of recurrent VVC.
Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur well for the ongoing, late-stage program with the compound as an adjunctive treatment in MDD.
Hopes remain for Unity Biotechnology Inc.’s UBX-1325 in diabetic macular edema (DME) following a phase II miss in wet age-related macular degeneration (AMD), where data from part A of the study called Envision fell short of the non-inferiority threshold when compared to Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) through 24 weeks.
Phase II data that rolled out from Merck KGaA with its Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in relapsed multiple sclerosis (MS) put more eyeballs on the mechanism. It’s already well validated in oncology, but resistance has arisen there, and at least two firms – Beigene Ltd. and Nurix Therapeutics Inc. – are striving for solutions with degrader candidates.
