Friday, April 12, 2024
AdrenoMed AG, a company specializing in vascular integrity solutions, has announced that its lead product candidate, enibarcimab, has received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of septic shock. Enibarcimab is a novel non-neutralizing monoclonal antibody targeting this serious medical condition. AdrenoMed plans to conduct a confirmatory Phase IIb/III clinical trial to further validate the effectiveness of enibarcimab in reducing mortality associated with septic shock, using a precision medicine approach.
Enibarcimab binds to the vasoprotective hormone adrenomedullin and has shown promising results in improving organ function and significantly reducing day 28 all-cause mortality rates in patients with septic shock, particularly those identified by specific biomarkers. Septic shock poses a significant public health burden worldwide, with high mortality rates, making the development of effective treatments crucial.
The FDA's Fast Track designation expedites the regulatory review process for drugs targeting serious unmet medical needs. AdrenoMed's approach, guided by biomarkers, allows for the identification of patient populations most likely to benefit from enibarcimab treatment. This designation reflects the FDA's acknowledgment of the urgency in addressing septic shock and the potential of enibarcimab to provide much-needed therapeutic options.
Source: globenewswire.com
