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- Amsulostat poised for late-stage clinical development
- Positive Type C meeting outcome with U.S. FDA
- Feedback supports phase 2b design for Syntara’s lead asset
- Competitive and differentiated drug profile with near-term potential
Syntara (ASX:SNT) has received positive feedback from the US Food and Drug Administration (FDA), which is expected to lead to fast-tracking of the phase 2b study design for its amsulostat candidate for the treatment of patients with myelofibrosis (MF).
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Disclaimer: This content has been prepared as part of a partnership with Syntara Ltd and is intended for informational purposes only.
The clinical-stage drug development company participated in a constructive in-person Type C meeting with the FDA, which is then supporting the proposed phase 2b study design and has provided guidance on the details of the study and overall development pathway for amsulostat.
Syntara CEO Gary Phillips said the feedback represents a major milestone for the company, enabling progression into late-stage clinical development and creating opportunity for further engagement with potential commercial partners.
“We are delighted to have received a positive FDA review of the trial protocol for the planned Phase 2b study,” Mr Phillips declared.
“Amsulostat has a differentiated and competitive safety and efficacy profile, with strong potential as a breakthrough therapy for MF patients with an inadequate response to standard of care.
“We are also advancing amsulostat’s development into myelodysplastic syndrome (MDS), where two clinical studies are currently ongoing.”
The Phase 2b study will be a double blind, placebo-controlled study of amsulostat added to the standard of care (JAK inhibition) for patients who have had an inadequate response.
The primary endpoint will be the achievement of 50% reduction in total symptom score (TSS50) after nine months of treatment. Subject to final protocol review, the number of patients to be studied is expected to be approximately 100.
Lead candidate amsulostat (a.k.a. SNT-5505 and previously, PXS-5505) is being developed for the bone marrow cancer myelofibrosis, which causes a build-up of scar tissue that leads to loss of red and white blood cells and platelets.
Amsulostat has been granted Fast Track Designation, having already achieved FDA Orphan Drug Designation and clearance under an investigational new drug application for development in myelofibrosis.
Amsulostat has now completed a Phase 2a trial in myelofibrosis in which it was dosed as monotherapy and in combination with a JAK inhibitor.
SNT is steady at 3.2¢. Mkt cap $52.29M.
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