Health Check: Argenica hits stroke safety endpoints; efficacy results mixed

• Argenica shares fall on phase II trial results, but management says drug appears effective in an important patient sub-group
• 4D Medical shares soar on reimbursement news
• What’s up doc? Dunno, we don’t go there

Argenica Therapeutics (ASX:AGN) will forge ahead with its clinical program for post-stroke brain protection, after releasing top-line results showing its therapy was safe and well tolerated among the 92 study participants.

However, the trial, named Seancon, missed its secondary efficacy endpoint with the drug candidate ARG-007 showing no treatment difference across the entire cohort, relative to placebo.

But management is buoyed the therapy did benefit a “Goldilocks” sub-group of patients, accounting for about one-third of the total cohort.

The efficacy measure related to reduced infarction, which is the death of tissue due to a lack of blood supply (typically caused by a blockage).

The benefit was apparent with highly at-risk patients with “slow collateral blood flow”.

This means that, post stroke, their brains had not developed enough alternative “tributaries” to get around  the blood blockage.

This results in infarction, the death of cells resulting from lack of blood flow.

In the “Goldilocks” group, ARG-007 resulted in a mean 15% reduction in “infarct’ volumes.

‘Clinically meaningful’

CEO Dr Liz Dallimore describes a 15% improvement as “absolutely clinically meaningful”.

“If we can hone in on that and get more confidence that that effect is real … that’s what we will be looking to do in a [further] clinical trial for sure”.

Dallimore adds that drug approval applications usually are weighted to the patient group for which a therapy shows the most benefit.

“We have found a signal we think [is] worth exploring,” says Dr Meghan Thomas, the company’s head of clinical and regulatory development.

The company said the result was consistent with its “pre-existing hypothesis” that these patients would benefit most from ARG-007’s “neuroprotective  potential”.

In other words, it wasn’t a ‘post hoc’, post-trial ‘data mining’ exercise.

Safety counts

Dallimore adds that investors should not downplay achieving the safety goals.

“I know no-one gets excited about safety … but it’s a big tick that we got safety in a really compromised group of patients.”

Thomas notes that while an earlier trial enrolled patients with an average age of 36, the participants in the current trial were aged 72 on average.

“More things can go wrong, so it was important to show our drug was safe with no adverse events relative to placebo.”

Carried out across eight hospital emergency departments (EDs), the Seancon trial recruited patients undergoing a thrombectomy.

Despite the difficulties of an ED setting, the trial enrolled six months ahead of the planned schedule.

Meanwhile, the company says it remains well funded to pursue further development activities, with a current cash balance of $7 million and an expected R&D tax rebate of $3.5-4 million.

As of noon, Argenica shares had fallen about 60%.

4D Medical wins US reimbursement

 4D Medical’s (ASX:4DX) purple patch continues, with the lung imager winning US public reimbursement for its software tool CT:VQ.

On Monday, 4D announced US Food & Drug Administration approval for the software, which is the first to assess perfusion (blood flow) without needing radiation or contrast agents (which can damage the liver).

This especially relevant for pulmonary embolisms.

The Centers for Medicare and Medicare Services has assigned category III reimbursement, at US$650.50 per scan.

This is on top of healthcare provider’s standard computer tomography (CT) scan payment.

“Hospitals and imaging centres can now confidently integrate CT:VQ into standard clinical workflows, knowing they will receive payment through established systems.”

On Monday 4D spoke of average reimbursement of US$1150 for PE scans, with more than one million assessments annually that require nuclear medicine.

For US reimbursement nerds, the payment will be made available as a New Technology Ambulatory Payment Classification,  under the Hospital Outpatient Prospective Payment System.

4D founder and CEO Dr Andreas Fouras dubs the reimbursement as a game hanger.

“We’ve cleared regulatory and reimbursement hurdles in quick succession, removing the biggest barriers to adoption and bringing us closer to redefining functional lung imaging at scale.”

The tool extends advanced diagnostic capabilities to healthcare facilities lacking   nuclear medicine facilities, such as in regional areas.

In a note ahead of this morning announcement , Bell Potter expected reimbursement to be similar to the payment applying to 4D’s earlier approved tool, CT:LVAS (as in ‘lung ventilation analysis software’)

“While this event will take some time to work through to revenue generation, the hospital economics are highly compelling,” the note says.

Bell Potter has hiked its 4D valuation from 77.5 cents per share, to $1.05.

The firm forecasts current yar revenue $11.5 million and a $20.8 million loss.

4D Medical shares today surged 28%, taking the gains over the last month to 175%.

Aussies shun their GPs

The latest monthly Medicare official stats show that Australians are either a hardy uncomplaining lot in the face of niggling health woes, or too poor to visit their doc.

We’ll assume the former, of course.

GP attendance data for July shows a 0.1% increase, which follows on from a 4.4% decline in June. That’s a 90-basis point (bp) decrease on the 12-month rolling average and long-term median growth number of 1.2%.

Face-to-face doctor visits fell to almost zero, compared with 12-month median of 1.2%.

The GP downturn flows through to diagnostic imaging volumes, which came in at 3.2%, a 90 bp decline on the rolling number.

Pathology volumes declined to 1.5%, which compares to a 4.4% rolling average.

Two factors could provide headwinds.

The deregulation of magnetic resonance imaging (MRI) means specialists can refer patients directly for radiology scans, thus removing the GP intermediary.

There’s also the national lung cancer screening program.

Pathology/imaging plays Sonic Healthcare (ASX:SHL) and Healius (ASX:HLS) last month produced lacklustre full-year results.

Integrated Diagnostics fared better, with its merger with Capitol Health delivering the goods.

Meanwhile, Australian Prudential Regulation Authority data shows that claims paid by private health insurers moderated to 1%, supported by negative claims inflation.

In the ASX-listed context, Medibank PrivateMedibank Private (ASX:MPL) and NIB Holdings (ASX:NHF) are getting the better end of the deal, at the expense of private hospital operator Ramsay Healthcare.

Biome is on a roll

With a little under four weeks to go until the end of the September quarter, microbiome health outfit Biome Australia (ASX:BIO) confident enough to forecast sales revenue of more than $5.5 million for the stanza.

That’s a record performance, surpassing the June quarter benchmark of $5 million.

Biome recorded revenue of $18.4 million, up 42% and a maiden profit of $214,656.

Available at all good chemists, Biome’s activated (live) probiotics treat conditions such as low mood, sleep disorders, bone health, eczema, iron malabsorption and irritable bowel syndrome.

Available only via doctors, an activated therapeutics range tackled perimenopause, gastrointestinal repair, acid reflux and weight management.