All articles tagged with #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.
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 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.