FDA grants fast-track status for LimmaTech's vaccine

According to a press release, LimmaTech Biologics is able to work with an accelerated review process from the US Food and Drug Administration (FDA) for the further development of its vaccine candidate LBT-SA7. The Food and Drug Administration has granted fast-track status to the multivalent toxoid vaccine candidate LBT-SA7. It was developed by LimmaTech for the prevention of skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus (S. aureus).

According to the statement, it is estimated that more than 1 million deaths are attributable to S. aureus each year. 90 percent of all community-acquired S. aureus infections are skin and soft tissue infections that can be treated with LBT-SA7. The vaccine candidate contains attenuated forms of the pathogen's toxins to prevent infection by neutralizing the toxins.

"LBT-SA7 represents a fundamentally new approach to staphylococcal vaccine development that aims to neutralize toxins and prevent their harmful effects on affected humans," Michael Kowarik, Chief Scientific Officer of LimmaTech, is quoted as saying. "Our Phase 1 clinical trial aims to demonstrate the safety of our vaccine candidate in healthy volunteers and to confirm the toxin-neutralizing activity induced by the vaccine."

LBT-SA7 is being tested in a randomized, double-blind, controlled Phase 1 dose-escalation study at a clinical trial site in the US, involving 130 participants aged 18 to 50 years. Safety and immunogenicity are evaluated. The first results are expected in the second half of 2025.

LimmaTech is based in the Bio-Technopark Schlieren-Zurich. ce/gba