相关临床试验
9
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
4
44.4%
已完成
4
44.4%
招募中
1
11.1%
暂无批准数据
- Syntara has secured $8 million in firm commitments through an institutional placement, with an additional $2 million share purchase plan for existing shareholders. - Proceeds will fund five clinical trial readouts in 2026 and preparation of the Phase 2b study for lead asset amsulostat in myelofibrosis. - Amsulostat holds both FDA Fast Track and Orphan Drug designations, underscoring the unmet need in myelofibrosis treatment. - The capital raise extends Syntara's cash runway through Q3 2027, positioning the company to deliver multiple pipeline data catalysts.
- Syntara Limited received FDA guidance recommending a Phase 2 controlled trial for amsulostat in myelofibrosis to gather additional safety and efficacy data. - The FDA reviewed data from the ongoing MF-101 trial combining amsulostat with ruxolitinib and a proposal for a pivotal registrational study during a Type C meeting. - The Phase 2 trial will focus on symptom improvements and spleen volume reductions to optimize the design of a subsequent Phase 3 trial. - Syntara expects to report top-line Phase 1c/2 data for amsulostat in myelofibrosis in Q3 2025, with strong financial runway extending into 2027.
- Syntara Limited has dosed the first participant in a Phase 1a/b clinical trial of SNT-9465, a topical pan-lysyl oxidase inhibitor designed to treat hypertrophic scars. - The trial will initially assess safety and tolerability in healthy participants before moving to a Phase 1b extension evaluating improvements in scar appearance and composition after three months of daily treatment. - Current standard care for hypertrophic scars includes costly laser therapy or painful steroid injections requiring multiple treatments for only small incremental improvements. - Trial results expected in the first half of 2026 are anticipated to support an FDA IND application for what could become the first approved pharmacological treatment for skin scarring.
- The US FDA has granted Fast Track designation to Syntara's SNT-5505 for treating myelofibrosis patients with inadequate response to JAK inhibitor therapy. - SNT-5505 represents a novel therapeutic approach by inhibiting lysyl oxidases, addressing significant unmet medical needs in this rare bone marrow cancer. - The designation enables more frequent FDA interactions, eligibility for Priority Review and Accelerated Approval, potentially expediting patient access to treatment. - Clinical studies have demonstrated that SNT-5505 improves patient quality of life with an excellent safety and tolerability profile.
