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.
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.
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.
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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