Immunology company Freya Biosciences has reported positive Phase I results for its treatment for IVF-related embryo implantation failure. 

FB301, a defined multi-strain Lactobacillus consortium developed using Freya’s Dyscover platform, was safe and well tolerated in healthy female subjects, with all primary and secondary endpoints met. 

The trial was a randomised, placebo-controlled, double-blind first-in-human trial investigating safety, tolerability, and proof-of-concept. A total of 129 participants aged 18 to 45 were enrolled, of whom 89 were randomised across three dosing cohorts at a single study site in Germany. 

Treatment with FB301 resulted in a significant increase from baseline in the relative abundance of selected Lactobacillus species in vaginal samples, indicating modulation of the vaginal microbiome towards a more advantageous state.  

In participants who were dysbiotic at baseline (the modified intention-to-treat population), treatment with FB301 led to conversion to a Lactobacillus-dominant microbiome profile across all dosing cohorts.  

“FB301 showed a favourable safety profile across all dose levels and demonstrated clinically meaningful microbiome changes, including increases in key Lactobacillus species in the vaginal environment that are associated with superior health outcomes,” said Colleen Acosta, Chief Executive Officer of Freya Biosciences. 

“Taken together, the data support the proposed mechanism of action of resolving a dysbiotic vaginal microbiome and addressing underlying inflammation, providing a strong foundation for clinical development in women undergoing assisted reproductive technologies.  

“As we advance into Phase II, our focus will be on confirming these findings in patient populations and progressing the development of a much-needed new therapeutic option that could help improve outcomes for the millions of women undergoing IVF worldwide.”