Our pipeline spans muscle loss, hair loss, progeria, neurodegenerative disease, fibrosis and metabolic liver disease, and every program is built on the SenoReverse™ platform. Our two priorities, sarcopenia and androgenetic alopecia, are each advancing toward an FDA IND to begin Phase 1.
For both priority programs, we are working toward an FDA IND to begin Phase 1. Investigator-initiated trials (IITs) are approved by hospital ethics committees and are separate from FDA IND submissions.
With treatment, naturally aged mice regained grip strength and stayed longer on an accelerating rotarod. Building on these results, we have received ethics committee approval for an IIT.
Schematic trends of group means in naturally aged male mice. Higher is better; not to scale.
Regained, then exceeded aged controls
Stayed longer on an accelerating rotarod
An IIT has read out: hair density, follicular unit density and other endpoints improved versus control.
Direction of change versus control only.
Improved versus control
Improved versus control
An early investigator-initiated trial has been completed. Preliminary results showed improved function and lower levels of neurofilament light chain (NfL), a biomarker of neuroaxonal damage. These results support further clinical development.
Function
Improved
NfL
Fell
Four workstreams inform dose selection and support regulatory filings for our priority candidates.
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