Health Check: Hold the front page for a rush of clinical trial updates

Emvision expects to release trial results for its Emu stroke-detection device in November
Syntara’s rare blood cancer program gathers pace
Actinogen says 25 patients have been treated in its 200-candidate Alzheimer’s disease study

Quarterly reports from the biotech sector are falling from the skies like spring pollen and the wise companies are augmenting the basic anodyne numbers with trial and commercialisation updates.

Many of them are also fronting two Melbourne jamborees – Ausbiotech 2024 and the 13^th Australian Microcaps Investment Conference – so investors aren’t exactly starved for news. Or in some cases rehashed news, but never fake news.

We’ll start with stroke detection innovator EMvision Medical Devices (ASX:EMV), which expects to release the results of a phase III pre-validation trial in November.

That’s next month, come to think of it.

The device in question is Emu, a lightweight gizmo that can determine whether a stroke is a clot (ischaemic) or a bleed (haemorrhagic).

It kinda makes a difference, because commonly used blood-thinning drugs can’t be used for the latter.

The current recommended method of non-contrast computed tomography (NCCT) is good at ruling out haemorrhage, but not so flash at detecting acute ischemia.

CT (computed tomography) or magnetic resonance imaging (MRI) scans are often needed, but the gear required is bulky, expensive and needs specialist operators.

Emvision reports it has recruited 307 patients across multiple sites, here and in the US. These patients included 277 suspected stroke victims and 30 patients with rarer haemorrhagic strokes.

The scans provided “valuable data to power Emvision’s neurodiagnostic ‘blood or not’ and ‘ischemia or not’ AI algorithms”.

The size of a current medical cart, Emu weighs around 100 kilograms, compared with around 600 kegs for the current imaging kit. So, it can be wheeled to the bedside of patients who can’t be whisked off to the radiology department for whatever reason.

Based on electro-magnetic microwave imaging, the helmet-like devices can take an image and diagnose the type of stroke within five minutes.

Emvision also has an even lighter 10kg variant device for use in ambulances, First Responder, which is in proof-of-concept stage.

Emu and First Responder won’t replace the current CT or MRI-based stroke imaging methods, but create high-contrast, supplementary images.

Emvision is vying for US Food & Drug Administration (FDA) approval and recently met with the agency to discuss the structure of a planned validation trial to support a marketing approval application under the de novo (new device) route.

“The meeting reinforced our confidence that Emvision’s strategic direction is appropriately aligned with the FDAs requirements,” the company says.

The first hour – the Golden Hour – is the most important for stroke victims in terms of receiving treatment and minimising brain damage – and the last thing first responders want to do is faff around with the ‘blood versus clot’ determination.

Strokes are the world’s second biggest killer, with 15 million cases a year (55,000 in Australia, or 150 per day).

Emvision’s quarterly showed cash outflows of $1.72 million and a September-end balance of $16.85 million.

Emvision shares were steady at $1.90.

Syntara says: circle December 7 for blood cancer trial news

Meanwhile, inflammatory diseases specialist Syntara (ASX:SNT) says investors should expect key trial data on December 7 – not that far off, either.

This one relates to Syntara’s lead program for the rare bone marrow cancer myelofibrosis, which affects about 15 in one million people.

The open-label phase 2a effort involves dosing 15 patients with Syntara’s candidate SNT-5505, in combination with the standard-of-care janus kinase (JAK) inhibitors.

The company in July completed enrolment of 15 patients, with 12 of them undergoing at least one month of treatment.

The company has already reported on stage one of the trial, which enrolled 24 patients who did not respond to JAK inhibitors. The safety stats were good and of the 11 evaluable patients, five had improved bone marrow fibrosity scores.

The company expects the interim numbers – to be unveiled at the American Society of Haematology get-together in San Diego – to “drive FDA discussions on pivotal trial design and potential partnering interest”.

CEO Gary Phillips says: “We expect we will seek a meeting with the FDA in the first half of 2025 once we have enough data to fully characterise the safety and efficacy profile of the drug.”

So Syntara – formerly known as Pharmaxis – is getting to the pointy end of things but it needs to watch its bank balance.

Syntara’s quarterly report showed outflows of $4.23 million, with a September-end cash of $4.33 million after a $5 million raising.

That’s only enough dosh for another quarter but things are not quite so bad, as the company subsequently pocketed $4.56 million in an R&D tax incentive, a $934,000 security deposit on relinquished premises and $625,000 from the sale of its legacy business (mannitol, for cystic fibrosis).

The company reveals it is pursuing an outstanding $3.9 million payment from the purchaser, Arna Pharma and we hope that effort doesn’t need to resort to baseball bats and legal letters.

Syntara shares fell 135 to 3.8 cents.

Xanamia! Actinogen’s Alzheimer’s program gathers pace

Meanwhile, Actinogen Medical (ASX:ACW) reports the pace of recruitment is stepping up for its phase 2b trial of its proposed drug for Alzheimer’s disease, which has proved an especially tricky indication over the past few years.

The trial, Xanamia, aims to recruit 200 participants across four active sites in the US (with a further six expected by the end of the year) and 15 local sites.

25 patients have been treated to date, with a further five “in coming weeks”.

Investors should expect an interim analysis read-out in mid 2025, after 100 patients have been treated for 24 weeks.

The trial targets patients with elevated levels of the Alzheimer’s blood biomarker pTau181, whose disease is likely to progress over the 36-week treatment period.

This will accentuate treatment benefit from Actinogen’s candidate Xananem, a brain tissue cortisol synthesis inhibitor.

Other Alzheimer’s drugs work by inhibiting the formation of amyloid protein plaque, which are thought to be a key contributor to the disease.

Xanamem takes a different tack by inhibiting production of cortisol.

Actinogen’s quarterly showed outflows of $3.578 but a healthy September-end cash balance of $13.58 million following a $7 million raising.

Actinogen shares were flat at 2.4 cents.