Sirnaomics Ltd. is gearing up to start either an expanded phase IIb or 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.
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.
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.
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.
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.
It is a “landmark moment” in the long-awaited upgrade of the management of clinical research in Europe, but the industry has given a lukewarm welcome to a mandate to submit all clinical trial applications via the EMA’s clinical trials information system, as of Jan. 31.
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
Vera Therapeutics Inc.’s latest results from the phase IIb Origin trial with atacicept in patients with IgA nephropathy (IgAN) provided cause for optimism with regard to the phase III experiment targeted for the first half of this year – which should yield 36-week data in the first half of 2025 – and the company is budgeting to make the later-stage effort happen.
Equilibre Biopharmaceuticals Corp. has positive top-line data from the phase II study of its lead asset, EQU-001, an anti-inflammatory adjunctive therapy for treating focal seizures for adults with epilepsy.
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