Recent highlights

Preliminary analysis of SNT-4728 iRBD Phase 2 study results provides encouraging signs of reduced brain inflammation

First interventional study to directly target neuroinflammation in patients with isolated REM Sleep Behaviour Disorder (iRBD) and interrogate the disease biology underlying patient progression to Parkinson’s Disease Statistically significant reduction in brain inflammation was observed unilaterally in the putamen (p-value 0.0145), with 20 out of 30 patients on active treatment (SNT-4728) recording a reduction from…

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Investor Update Webinar

Syntara CEO Gary Phillips hosted an investor webinar to discuss recent updates, including the positive FDA feedback supporting the planned Phase 2b trial of amsulostat in myelofibrosis, as well as the capital raising undertaken by the Company. Click here to view the replay

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Syntara announces placement of A$8 million and share purchase plan

Syntara has received firm commitments from existing and new institutional and sophisticated investors to raise A$8.0 million (before costs) by way of a two-tranche institutional placement (Placement). The Company intends to conduct a non-underwritten share purchase plan to existing eligible shareholders to raise approximately A$2.0 million (SPP) (together with the Placement, the Capital Raising or…

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Amsulostat poised for late-stage clinical development following positive FDA feedback

Positive Type C meeting outcome with US FDA supporting the Phase 2b design for Syntara’s lead asset amsulostat Amsulostat on target to advance into late-stage clinical development with a ~100 patient, placebo-controlled Phase 2b study in myelofibrosis Competitive and differentiated drug profile with near term potential for indication extension as two additional phase 1b/2 trials…

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Syntara receives A$1.7m SNT-4728 milestone payment from Parkinson’s UK

Syntara has received a milestone payment of approximately A$1.7 million (£900,000) from Parkinson’s UK, triggered by dosing of the final patient in its Phase 2 clinical trial of SNT-4728. The payment forms part of Parkinson’s UK’s funding commitment to support the development of SNT-4728, which is being evaluated as a potential treatment targeting neuroinflammation associated with…

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Amsulostat in pancreatic cancer Phase 1/2 clinical trial in collaboration with the Garvan, funded by MRFF

The Garvan Institute of Medical Research secures $3 million MRFF grant funding for two multicentre studies in advanced pancreatic cancer, including one testing Syntara’s amsulostat (SNT-5505) with standard-ofcare chemotherapy Syntara to contribute drug supply plus scientific and clinical expertise, with no cash funding required from the company The program builds on Garvan’s preclinical research, published…

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SNT-4728 completes recruitment in Phase 2 sleep disorder trial supported by Parkinson’s UK

Final patient recruited into Syntara’s randomised, double-blind, placebo-controlled Phase 2 study of first-in-class neuro-targeted anti-inflammatory therapy, SNT-4728, to treat isolated REM Sleep Behaviour Disorder (iRBD). iRBD affects around 2% of individuals over 50 years of age, and up to 90% of these patients progress to a neurodegenerative disease, highlighting a substantial unmet medical need. In…

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Skin scarring program to progress on positive Phase 1a results

Next generation topical anti-fibrotic, SNT-9465, to progress to Phase 1b study in hypertrophic scars following successful completion of Phase 1a Phase 1a Single Ascending Dose clinical trial confirmed dose-dependent target engagement with good safety profile Randomised, double-blinded, placebo-controlled innovative Phase 1b trial design for hypertrophic scars using state of the art evaluation tools to commence…

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Further endorsement of amsulostat’s potential with positive opinion for Orphan Drug Designation in the EU for myelofibrosis

Syntara Limited (ASX: SNT), a clinical-stage drug development company, is pleased to announce that it has received a positive opinion on the submission of Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its advanced clinical asset amsulostat (SNT-5505) for the treatment of myelofibrosis (MF). An ODD grant will provide numerous incentives for…

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Positive top-line Phase 2a data confirms amsulostat’s competitive profile in myelofibrosis

Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to announce top-line data from the Phase 2a clinical trial evaluating amsulostat (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF). The open-label study evaluated the safety and efficacy of amsulostat over 52 weeks. Patients with intermediate-2 or high-risk MF…

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First participant dosed in SNT-9465 Phase 1a/b trial targeting hypertrophic scars

Highlights: SNT-9465 is a next-generation topical anti-fibrotic drug developed for the treatment of skin scarring. Initial phase of the trial will observe the safety and tolerability of SNT-9465 in healthy participants with skin biopsies to measure drug concentration and enzyme inhibition. Potential for SNT-9465 to address unmet need for patients with hypertrophic scars who rely…

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Initiation of Phase 1b/2 AZALOX clinical trial of amsulostat in second blood cancer indication

Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to report initiation of AZALOX, a Phase 1b/2 multi-centre study evaluating amsulostat (SNT-5505) in combination with 5-Azacitidine for the treatment of high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML). The study commenced at University Medicine Mannheim (UMM), Germany, the first of nine planned centres…

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WHO grants official INN for Syntara’s clinical development asset SNT-5505: amsulostat

Syntara Limited (ASX: SNT), a clinical-stage drug development company, today announces that the World Health Organization (WHO) has formally granted the International Non-Proprietary Name (INN) of amsulostat to its advanced clinical development asset SNT-5505. Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.…

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SNT-5505 awarded US FDA Fast Track designation

Syntara Limited (ASX: SNT), a clinical-stage biotechnology company focused on developing first-in-class treatments in blood cancers and other fibrotic diseases, today announces that its lead candidate, SNT 5505, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of myelofibrosis in patients with an inadequate response to JAK…

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Syntara announces positive interim data in Phase 2 study of SNT-5505 in myelofibrosis

Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to announce positive interim data from its ongoing Phase 2 clinical trial evaluating SNT-5505 (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF). The interim results suggest that SNT-5505 has potential as a breakthrough therapy for MF and are being…

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Syntara selected for oral presentation at ASH to present interim Phase 2 blood cancer trial data

Clinical stage drug development company Syntara Limited (ASX: SNT) is pleased to announce that its abstract1 has been has been selected for an oral presentation at the American Society of Haematology meeting (ASH) where interim results from its Phase 2 trial evaluating SNT-5055, in combination with ruxolitinib to treat the bone marrow cancer myelofibrosis, will…

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New indication for Syntara lead asset SNT-5505 as German MDS study group awarded A$2.5m grant to conduct phase 2 blood cancer trial

Researchers at Heidelberg University to take SNT-5505 into the clinic for the blood cancers myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) with A$2.5m funding from Deutsche Krebshilfe (German Cancer Aid) The phase 1b/2 study (AZALOX) in patients with high risk MDS and CMML will commence Q1 2025, running in parallel with the previously announced…

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Phase 2 blood cancer trial fully recruited – interim results due December 2024

Syntara has completed full recruitment in its Phase 2 trial evaluating SNT-5055, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis. Recruitment target achieved as 15th patient dosed 12 patients exceed one month treatment and surpasses minimum threshold proposed in FDA discussions for safety evaluation. No drug related dropouts & no serious adverse reactions…

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Syntara Announces Two-Tranche Placement to Raise A$5m

Syntara receives firm commitments to raise approximately A$5.0 million via a two-tranche placement at A$0.028 per share. Funds raised to provide certainty of funding towards completion of the Company’s Phase 2 clinical trials subsequent to the acquiror of the Company’s mannitol business unit (MBU) recently challenging amounts. The total amount currently claimed by Syntara from…

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Phase 2 Trial Reaches 50% Recruitment

Syntara has reached the 50% recruitment milestone in its Phase 2 trial evaluating SNT-5505, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis. Recruitment for the open-label study commenced in December 2023 with the 8th patient in the 15-patient trial dosed earlier this week, keeping Syntara on track for completion of recruitment by the…

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Syntara completes two-tranche placement of A$10m

Syntara completes A$10.0 million via a two-tranche placement at $0.022 per share. The Company completes Share Purchase Plan (SPP) that provided all eligible shareholders the opportunity to participate in the transaction. Funds raised will be used towards completion of three Phase 2 clinical trials in myelofibrosis, scarring and iRBD/Parkinson’s disease as well as for general…

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First patient dosed in Phase 2 bone marrow cancer trial of SNT-5505 in combination with ruxolitinib.

The combination therapy study is recruiting patients from 19 clinical trial sites in Australia, South Korea, Taiwan and the USA. It follows results from an earlier cohort demonstrating SNT-5505 had an excellent safety profile and encouraging signs of efficacy when used in patients who had failed on current standard of care. Watch a Proactive interview…

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Syntara doses first patient in Phase 2 trial of patients with sleep disorder at risk of Parkinson’s disease

Syntara has announced the first patient has been dosed in its randomised double-blind placebo controlled Phase 2 study of the Syntara drug discovery PXS-4728 studying patients with isolated Rapid Eye Movement Sleep Behaviour Disorder (iRBD) who are at risk of Parkinson’s disease. The study will examine whether targeting inflammation in the brain of people with…

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Sale of mannitol respiratory business and launch of Syntara

Pharmaxis has announced details of the sale of its mannitol respiratory business which manufactures and supplies Aridol and Bronchitol to global markets and the formation of Syntara, a clinical stage drug development company primarily focusing on treatments for haematological malignancies (blood-related cancers). In a major restructure the mannitol business will be sold to pharmaceutical manufacturing…

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Publication in Nature Cancer

The prestigious journal Nature Cancer has published preclinical results showing Pharmaxis’ pan-Lysyl Oxidase (pan-LOX) inhibitor PXS-5505 increases survival by 35% compared to chemotherapy treatment alone in the treatment of pancreatic ductal adenocarcinomas. Research in mouse models, led by a team at the Garvan Institute of Medical Research also showed PXS-5505 combined with chemotherapy reduced the…

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Pharmaxis achieves 30% reduction in scar tissue in topical LOX inhibitor in Phase 1C study; extends collaboration with UWA

Pharmaxis’ novel topical drug treatment for scarring has achieved encouraging results from a phase 1c showing marked change in scar composition with 30% reduction in collagen content. The study of LOX inhibitor PXS-6302 is being conducted by the University of Western Australia (UWA) under the leadership of Professor Fiona Wood AM.  The study aims to…

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