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Phase I Trial

All articles tagged with #phase i trial

Could an Exercise Pill Pass Its First Human Safety Check? ENV-308
science16 days ago

Could an Exercise Pill Pass Its First Human Safety Check? ENV-308

Enveda’s ENV-308, a pill designed to mimic the exercise-linked molecule Lac-Phe, successfully completed a Phase I trial in 88 healthy volunteers, showing safety, tolerability, and an exceptional GI safety profile. Early signs suggest it may influence leptin levels and aid weight maintenance and muscle preservation, with Phase II planned for weight-loss maintenance and exploration in migraines and inflammatory bowel disease. It’s not a substitute for real exercise, but could offer a convenient metabolic aid as development continues.

AI-Crafted Universal Coronavirus Vaccine Clears Phase I Trial
science3 months ago

AI-Crafted Universal Coronavirus Vaccine Clears Phase I Trial

Researchers at Cambridge used AI to design a pan-coronavirus vaccine, pEVAC-PS, which in a Phase I trial in 39 healthy volunteers appeared safe and elicited cross-reactive immune responses to multiple sarbecoviruses; the team plans Phase II trials and has spun off DIOSynVax to commercialize the AI platform for universal vaccines against threats like flu and Ebola.

One-shot gene-editing therapy reduces LDL by up to 62% in early trial
science3 months ago

One-shot gene-editing therapy reduces LDL by up to 62% in early trial

In a small Phase I study, Verve Therapeutics’ VERVE-102, a one-time mRNA-based gene-editing therapy targeting PCSK9, reduced LDL by up to 62% in the highest-dose group among 35 participants, with no serious safety events aside from a transient mild rise in a liver enzyme; results suggest durable LDL-C lowering, but larger and longer trials are needed for confirmation, and the FDA has granted Fast Track designation.

VBI Vaccines' Pan-Coronavirus Vaccine Offers Broad Protection Against Variants
health2 years ago

VBI Vaccines' Pan-Coronavirus Vaccine Offers Broad Protection Against Variants

VBI Vaccines' pan-coronavirus vaccine candidate, VBI-2901, demonstrated broad and durable protection against variants of concern in a Phase I trial involving 101 adults who had received mRNA COVID vaccines. The vaccine produced high neutralizing responses against multiple COVID-19 variants, including Wuhan, Delta, Beta, and Omicron BA.5, as well as animal coronaviruses. The protective titers remained stable at the six-month interim data point, with no safety concerns. Participants with low baseline neutralization titers showed the greatest vaccine-induced boosting effects. VBI's stock rose over 18% following the positive clinical data.