Clinical Trial News

Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in a global study among cisgender women, with findings to be presented at the 2024 International AIDS Conference.

Merck announced positive topline results from its Phase 2b/3 trial of clesrovimab (MK-1654), an investigational RSV preventative monoclonal antibody for infants, meeting primary safety and efficacy endpoints including reducing medically attended lower respiratory infections caused by RSV through Day 150.

FDA approves Epysqli (eculizumab-aagh), a biosimilar to Soliris for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), based on evidence showing high similarity to Soliris without clinically meaningful differences in safety, purity, and potency.

60 Degrees Pharmaceuticals has partnered with Yale University, Tufts Medical Center, and Rhode Island Hospital to conduct a clinical trial on tafenoquine's efficacy and safety in treating babesiosis, a tick-borne infectious disease.

Restore Medical's ContraBand device, a transcatheter pulmonary artery banding system for HFrEF patients, received FDA breakthrough designation. It aims to improve life quality via a minimally invasive procedure, supported by positive clinical trial results showing symptom improvement in patients on GDMT.

Zymeworks Inc. announced FDA clearance for ZW191, a novel FR⍺-targeted ADC for difficult-to-treat cancers, highlighting its unique antibody-linker stability and payload potency. ZW191 targets ovarian, gynecological cancers, and NSCLC, with clinical studies expected in 2024. Zymeworks is advancing a pipeline of ADCs and multispecific antibodies, including zanidatamab for HER2-positive BTC, aiming to address unmet medical needs.

Recent findings from the TEASE-3 trial presented at the 42nd American Society of Retina Specialists Annual Scientific Meeting indicate that once-daily gildeuretinol acetate may effectively halt the progression of early-stage Stargardt disease, offering hope for patients with this genetic condition.

FDA approves Zituvimet XR, a sitagliptin and metformin hydrochloride extended-release tablet, for adults with type 2 diabetes, manufactured by Zydus Lifesciences Limited.

Rezatapopt, a first-in-class p53 Y220C reactivator, shows promise in targeting the previously 'undruggable' p53 Y220C mutation in advanced solid tumors. Currently in phase 1/2 PYNNACLE study, it has demonstrated efficacy and tolerability across various tumor types, with a recommended phase 2 dose of 2000 mg daily. Early results indicate notable activity in refractory cancers, with ongoing phase 2 studies aiming to further clarify its effectiveness and potential for FDA approval.

Phathom Pharmaceuticals announces FDA approval of Voquezna (vonoprazan) tablets for treating heartburn associated with Non-Erosive GERD in adults, marking a significant milestone for millions of GERD patients.