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BioWorld - Saturday, February 4, 2023
Home » Topics » Clinical

Clinical
Clinical RSS Feed RSS

Light bulb shines next to extinguished ones

Spring cleaning starts early as Sanofi and others cut programs

Feb. 3, 2023
By Lee Landenberger
No Comments
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.
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Degradation of motor neurons

Myostatin approach gains ground in SMA; Biohaven, Roche, Scholar Rock in mix

Feb. 3, 2023
By Randy Osborne
No Comments
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.
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Illustration of diabetic foot ulcer, cross section of wound
Endocrine/Metabolic

Reactivation of fetal protein can lead to improved diabetic wound healing

Feb. 3, 2023
By Subhasree Nag
No Comments
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.
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Trial data on Atrogi’s new diabetes drug imminent

Feb. 2, 2023
By Cormac Sheridan
No Comments
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.
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Now COVA is over, Biophytis vies for a piece of the COVID-19 pie

Feb. 2, 2023
By Caroline Richards
No Comments
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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Precisedx improves prediction of early-stage breast cancer recurrence

Feb. 1, 2023
By Annette Boyle
No Comments
Precisedx Inc.’s digital artificial intelligence (AI) platform better predicts the recurrence of early-stage breast cancer within six years than traditional testing, a study published in Breast Cancer Research found. Understanding which patients with early-stage disease face significant risk of their cancer returning is important for guiding selection of treatment. The system reduces the variability inherent in histological characterization and grading of breast cancer (BC) today, thereby improving prognostic accuracy.
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Sirnaomics seeks FDA guidance for phase III skin cancer candidate

Feb. 1, 2023
By Caroline Richards
No Comments
Sirnaomics Ltd. is gearing up to start a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. STP-705 comprises two siRNA oligonucleotides that inhibit transforming growth factor beta 1 and cyclooxygenase-2 gene expressions and is delivered via injection using what the company describes as a polypeptide nanoparticle-enhanced delivery mechanism.
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Vial and syringe with DNA

Taysha ponders new study for ultra-rare disease as stock droops

Feb. 1, 2023
By Lee Landenberger
No Comments

Taysha Gene Therapies Inc.’s stock (NASDAQ:TSHA) struggled Feb. 1 following the U.S. FDA’s recommendation that the company dose more patients in a double-blind, placebo-controlled study of TSHA-120 for the ultra-rare indication giant axonal neuropathy.


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Man scratching arm

Evelo’s path in AD not EASI as placebo response garbles SINTAX of phase II effort

Feb. 1, 2023
By Randy Osborne
No Comments
Evelo Biosciences Inc.’s late-stage efforts with EDP-1815 are forging ahead despite unfavorable data in atopic dermatitis (AD), and talks so far with the U.S. FDA have proven encouraging, the company said. Cambridge, Mass.-based Evelo made public findings from the first three cohorts of the phase II trial with EDP-1815 in AD, where the compound fell short of the primary endpoint: proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score compared to placebo at week 16. Evelo blamed an unusually high placebo response rate.
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Blood glucose chart and monitor, stethoscope, injector pen

Sciwind Biosciences starts patient dosing in phase III clinical trial for ecnoglutide

Feb. 1, 2023
By Zhang Mengying
No Comments
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.
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