Syntara (ASX: SNT, $0.027) has been seeking an expedited path into Phase III for its myelofibrosis lead candidate, amsulostat.
The FDA has instead requested that Syntara conduct an additional 90-patient Phase II study with a placebo arm, which the current study lacks. This trial is expected to cost around US$25 million, take 12–18 months just to recruit, and run for roughly three years in total.
This outcome is a major setback because Syntara had been aiming to secure a licensing deal following FDA agreement on a Phase II/III protocol. The original plan included a Phase II lead-in that would transition directly into Phase III. At the recent Bioshares Biotech Summit, CEO Gary Phillips stressed that FDA validation of the Phase III program was critical to unlocking potential partnering deals.
Following the additional Phase II study, a Phase III program is anticipated to cost about US$80 million and enrol up to 300 patients. However, this requirement may be reduced due to the expanded Phase II trial. The new Phase IIb design will likely involve 60 patients on amsulostat and 30 on placebo. Clearer characterization of “suboptimal” patients — based on Total Symptom Score and spleen volume — will also be required.
To date, Syntara’s current Phase II study has recruited only 16 patients, testing amsulostat in combination with a JAK inhibitor. Phillips described early results as “startling,” noting that amsulostat blocks a second pathway and shows complementary benefit with JAK inhibitors, particularly in long-term disease.
Syntara now faces the challenge of advancing the Phase IIb myelofibrosis program. Beyond this, the company has multiple other studies underway: two in myelodysplastic syndrome with amsulostat, one in scarring with SNT-9465, and one in Parkinson’s disease with SNT-4728. Results from all programs are expected in the first half of next year. Phillips added that strong scarring data could lead to those assets being spun out into a separate entity.
Syntara reported $15 million in cash at the end of June, plus expected R&D tax rebates, giving it runway into 2027. However, further funding will be required to independently advance the Phase IIb myelofibrosis program.
Syntara is currently capitalized at $43 million.
Bioshares recommendation: Speculative Buy Class B
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