Seropeutics’ primary goal is to bring forward efficacious new therapies that address the needs of Fragile X syndrome patients and their families. There are currently no drugs approved for the treatment of Fragile X syndrome, thus caregivers must attempt to mitigate the multiple symptoms that may appear using drugs approved for other indications—few of which are reliably effective and most of which have significant side-effects. Seropeutics has made exciting progress in identifying two candidates, SERx – 519 and SERx – 480, which are at the preclinical development stage with promising potential to treat various symptoms related to Fragile X syndrome.  Next steps are as follows:

  • Seropeutics intends on advancing SERx – 519 and SERx – 480 into clinical development for treating their respective target Fragile X – associated symptoms.
  • Based on work done to date, we are positioned to file separate INDs for both candidates approximately 12 months after program funding.
  • We have completed preliminary CMC work and plan to engage an integrated CRO, Aptuit who specializes in CNS drugs to complete the remaining work necessary to file an IND.
  • We have engaged top KOLs for clinical trial design based on objective measurable endpoints to ensure reliable and efficient assessment of therapeutic efficacy.

Seropeutics is working with external partners to develop the best strategy for achieving orphan drug status for both of our Fragile X therapeutic candidates.