Phase 2b Tuberculosis Trial Doses First Patient with ALPE
Prior data on alpibectir-ethionamide (AlpE) showed a 7-day early bactericidal activity signal comparable to isoniazid and a generally acceptable...
eClinical Tech News
New Gedatolisib Breast Cancer Data from VIKTORIA-1 Study
In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial in HR+/HER2- advanced breast cancer post-CDK4/6 inhibitor, gedatolisib...
New Positive Results for Z-rostudirsen in DMD DELIVER Trial
Dyne Therapeutics reported 24-month analyses from the Phase 1/2 DELIVER trial showing improvements from baseline in lung function (FVC...
Rhythm Pharma Sees Positive Phase 3 Setmelanotide Trial Data
Setmelanotide delivered an 18.8% placebo‑adjusted difference in BMI reduction at 52 weeks in the Phase 3 TRANSCEND trial’s expanded...
New VIBRANT Trial Data on Verekitug for Chronic Nasal Polyps
Placebo-adjusted reductions in endoscopic nasal polyp score reached -1.95 (p < 0.0001) at Week 24 under a worst-observation carried-forward...
First Participants Enrolled in Spryte Medical’s InSyte Trial
Spryte Medical has enrolled the first participants in INSYTE, an FDA-approved IDE study evaluating a neuro-specific intravascular optical coherence...
CRISPR T-Cell Therapy for Solid Tumors Enters Clinical Trial
T-knife Therapeutics has received European authorization of its Clinical Trial Application to initiate ATLAS, an adaptive, first-in-human, open-label Phase...
Simcyp Simulation Replaces 10 Human Trials for CML Therapy
FDA accepted physiologically based pharmacokinetic (PBPK) predictions generated with Certara’s Simcyp platform in lieu of at least ten dedicated...
Arcutis Starts Phase 1 ARQ-234 Study for Atopic Dermatitis
Arcutis has enrolled the first participant in ARQ-234-131, a Phase 1a/1b, double-blind, randomized, placebo-controlled, first-in-human study of ARQ-234, a...
Medidata and CRIO Empower Sites, Accelerate Clinical Trials
Near-100% source-to-EDC data accuracy, roughly 90% faster data entry at sites, and adoption across more than 2,500 research sites...