Alnylam Achieves First Human Proof Of Concept For An RNAi Therapeutic With GEMINI Study
"With the positive results from GEMINI, we believe that Alnylam has demonstrated the first ever human proof of concept with an RNAi therapeutic," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "As such, these new data represent a key milestone and a major 'de-risking' event for the advancement of RNAi therapeutics, as well as important progress for our RSV program. While there's more to do in our efforts, these results also highlight Alnylam's continued leadership in the field of RNAi therapeutics, and our commitment to advancing this promising new class of medicines to patients."
The goal of the GEMINI study was to establish the anti-viral activity, safety, and tolerability of ALN-RSV01 in an experimental RSV infection model. GEMINI was a double-blind, placebo-controlled study, where a total of 88 adult subjects experimentally infected with RSV was randomized to receive ALN-RSV01 or placebo. ALN-RSV01 or placebo was administered intranasally for five consecutive days -- two days prior and three days after viral inoculation. Efficacy measures included infection rate and the effects of treatment on viral dynamics and clinical symptoms. As designed, GEMINI had sufficient power to detect a statistically significant difference in infection rate between ALN-RSV01 and placebo.
Results from this trial showed that:
- subjects receiving ALN-RSV01 experienced a 38.1% reduction in infection rate as measured by plaque assay (P
Alnylam uman realizeazã prima dovada de un concept pentru RNAi studiu terapeutic cu GEMENI - Alnylam Achieves First Human Proof Of Concept For An RNAi Therapeutic With GEMINI Study - articole medicale engleza - startsanatate