Syntara (SNT: $0.029) has outcomes from five clinical studies due this year. The closest of those is in isolated REM Sleep Behaviour Disorder (iRBD). Around 80% of people with this disorder go on to develop a neurodegenerative disease, such as Parkinson's, or dementia with Lewy Bodies.
The aim is to interrupt this process, potentially delaying the onset of these diseases with Syntara's drug candidate SNT-4728 which binds to the enzymes SSAO and MAO-B.
This drug candidate was originally licensed by Boehringer Ingelheim as a treatment for NASH (liver disease) and other inflammatory driven diseases. Eleven clinical studies have been conducted including two Phase II trials. Synatra received $83 million from the deal and believes Boehringer invested around $100 million in the compound.
The compound was returned in 2020 because of an off-target effect, that being the binding of the drug to the inflammatory enzyme MAO-B in the brain.
Approved Parkinson's drugs such as Selegiline inhibit MAO-B. MAO-B breaks down dopamine in the brain. Inhibiting this enzyme helps maintain dopamine levels in the brain and thereby improve motor function symptoms, the decline of which being the hallmark of this disease.
The other enzyme SNT-4728 inhibits, SSAO, has become an emerging biomarker of neurodegenerative diseases including Parkinson's disease, contributing to neuroinflammation and ingress of immune cells into the brain.
Parkinson's UK believes SNT-4728 may have an impact on the disease, potentially interrupting disease progression, noting that all current drugs for the disease reduce the symptoms only.
A hallmark of iRBD is people seeing to physically act out their dreams according to Syntara CEO Gary Phillips. With the advent of wearable technologies, measuring sleep behaviour and quality has become accessible for everyone, making clinical studies in this disorder relatively easy to monitor.
Forty patients were recruited into this study (recruitment completed in January) with a three month treatment period. The trial involves three dose arms and a placebo, so should provide reasonably clear data on any potential efficacy. The study is being conducted by University of Sydney and the University of Oxford in the UK.
The trial will be measuring sleep data, as well as PET imaging of the brain to seek to detect any changes in neuro-inflammation, specifically a reduction in the 'nigrostriatal region' volume through inhibiting microglia activation.
FDA Meeting Outcome and Partnering Discussions for Amsulostat
Another approaching milestone for Syntara is the outcome from discussions with the FDA with respect to Amsulostat for the treatment of myelofibrosis for the next Phase IIb study. Once the regulator and Syntara agree on a clinical trial pathway, it will open the door to a licensing deal believes Phillips.
At the NWR Healthcare Conference last month, Phillips said the company is talking with GSK, which acquired Sierra Oncology in 2022 for US$1.9 billion, and Sobi which acquired CTI BioPharma in 2023 for US$1.7 billion. Both acquisitions were for their programs in myelofibrosis. Phillips said some of the investors from Sierra and CTI are also investors in Syntara. There are around 20 companies that Syntara is in communication with regarding a potential licensing deal for Amsulostat in myelofibrosis.
What may bolster the chances of a good licensing deal for Amsulostat is positive data in myelodysplastic syndrome (MDS) which is also a bone marrow related disease like myelofibrosis. Outcomes from two physician-led studies in MDS are expected this year.
Capital Raise
This week Syntara announced a top-up capital raise of $8 million at $0.027 per share via a placement. The raise was conducted at a 17.6% discount to the five day weight average share price. It will give the company a proforma cash balance of $16.9 million at the end of March, excluding up to $2 million to be raised through an SPP.
Syntara is capitalized at $56 million following the placement.
Bioshares recommendation: Speculative Buy Class A
Disclaimer:
Information contained in this newsletter is not a complete analysis of every material fact respecting any company, industry or security. The opinions and estimates herein expressed represent the current judgement of the publisher and are subject to change. Blake Industry and Market Analysis Pty Ltd (BIMA) and any of their associates, officers or staff may have interests in securities referred to herein (Corporations Law s.849). Details contained herein have been prepared for general circulation and do not have regard to any person’s or company’s investment objectives, financial situation and particular needs. Accordingly, no recipients should rely on any recommendation (whether express or implied) contained in this document without consulting their investment adviser (Corporations Law s.851). The persons involved in or responsible for the preparation and publication of this report believe the information herein is accurate but no warranty of accuracy is given and persons seeking to rely on information provided herein should make their own independent enquiries. Details contained herein have been issued on the basis they are only for the particular person or company to whom they have been provided by Blake Industry and Market Analysis Pty Ltd. The Directors and/or associates declare interests in the following ASX Healthcare and Biotechnology sector securities: Analyst MP: 1AD, ACR, AVR, CGS, CUV, CYC, DXB, IMM, LBT, MX1, OPT, NEU, PAB, PXS,RNO,SOM. These interests can change at any time and are not additional recommendations. Holdings in stocks valued at less than $100 are not disclosed.
