Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
Shares in Idorsia Ltd. plummeted by around 14% Feb. 6 as the company announced that its phase III REACT trial investigating the use of Pivlaz (clazosentan) failed to reach the primary endpoint in patients who had experienced a type of stroke called aneurysmal subarachnoid haemorrhage, leaving the drug’s future in the U.S. and Europe uncertain.
It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
Spinal muscular atrophy (SMA) has been surfacing more regularly in scientific journals lately, as drug developers – such names as Biohaven Inc., Roche Holding AG and Scholar Rock Inc. – continue to search for improved therapies directed at the condition, one that takes in a group of hereditary, motor neuron-destroying diseases.
Researchers at Indiana University School of Medicine are exploring avenues to heal wounds by identifying proteins that are active in fetuses, but largely inactive in adults and absent in diabetic adults. They have identified a protein called nonselenocysteine-containing phospholipid hydroperoxide glutathione peroxidase, or NPGPx, that fits the bill and could be the basis for therapies aimed at diabetic wound healing. NPGPx is a direct transcriptional target of miR-29. miR-29 is downregulated in fetal tissue, thus NPGPx is active in fetal tissue but becomes mostly inactive in the skin after birth.
By next June or July, Swedish firm Atrogi AB expects to have data from a first-in-human phase Ia/Ib trial of its novel beta-2 adrenergic receptor agonist, ATR-258, which is in development for type 2 diabetes. The study has completed single ascending and multiple ascending-dose arms in 52 healthy volunteers and recently started recruiting 24 patients onto the phase Ib portion.
Biophytis SA’s investigational treatment for hospitalized COVID-19 patients with severe disease, Sarconeos (BIO-101), reduced the risk of respiratory failure or early death by 44% compared to placebo, final data from a phase II/III COVA trial show, but with the disease not being quite the emergency it once was, the drug’s future could be on shaky ground.
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