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Health & Biotech
ASX Quarterly Health Wrap: Action for Dimerix Phase 3 kidney trial
Health & Biotech
Key findings could boost Dimerix’s rare kidney disease drug trial
Health & Biotech
Health & Biotech
Broker Wilsons reckons ResMed (ASX:RMD) shares have some way to go after Friday’s solid September quarter numbers and following the “nonsense” sell-off caused by the emergence of Ozempic-class anti-obesity drugs.
Resmed’s deals with sleep apnoea (snoring) and obesity is a key cause of the voluble disorder. So thinner people mean less snoring and less demand for Resmed’s CPAP (continuous positive airways pressure) pumps and masks, right?
The thesis sounds a tad theoretical, but the fears of the overnight emergence of a legion of deep-sleeping svelte folk were largely the reason for Resmed shares halving between September 2021 to October 2023, to a nadir of $21.54.
Well, the stock is now almost back to where it was, having surged 8% since Friday numbers showing an 11% revenue surge to US$1.224 billion and 35% earnings bump to US$325.4 million.
The results were pretty consistent across the company’s two main divisions – sleep and breathing health and residential care software – and also geographically.
Wilsons says the stock has done “nothing other than recapture what it should never have lost, amid last year’s GLP-1Ra-driven nonsense.”
GLP-1Ra refers to the class of semaglutide drugs made famous by Ozempic, after the body-beautiful brigade commandeered the diabetes treatment.
The firm notes Eli Lilly expects to release a variant called tirzepatide, while Novo promises phase III data for a high-dose combination drug CagriSema.
Given that, the rest of the year could create some “opportunistic panic” that could create Resmed buying opportunities.
However, broker Citi is more sanguine, dubbing GLP-1s as a “potential risk [for Resmed] in the medium/long term, which needs to be balanced with the strong near-term operating performance and earnings momentum.”
The bigger risk for Resmed is the scope and timing of key rival Philips (Respironics’) return to the market after being forced to recall more than five million CPAP units.
Resmed shares this morning gained 1.75% to $38.39.
It looks like Dimerix (ASX:DXB) might get good news on what surrogate endpoints might be suitable for its pivotal phase III kidney disease trial.
A working group called Parasol confirmed the “strong correlation” between improved estimate glomerular filtration rates (eGFR) and the reduced risk of end-stage kidney disease.
But the work also suggests that levels of proteinuria – proteins seeping into the blood because of poorly-functioning kidneys – may also be acceptable as a surrogate endpoint.
Parasol is not an umbrella organisation, but a group of pre-eminent clinicians, patients, key opinion leaders, statisticians and – importantly – FDA reps.
Dimerix says: “There was general agreement from the FDA at the workshop that Parasol has likely provided sufficient data to support the relationship between a reduction in proteinuria and decreased risk of kidney disease progression.”
Presented to the American Society of Nephrology’s powwow in San Diego on Friday, the preliminary data analysis confirmed, among other things, “the strong correlation between the surrogate endpoint of improvement in eGFR and the clinical endpoint of reduced risk of end-stage kidney disease.”
A surrogate endpoint is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship.
For example, tumour shrinkage may be accepted as reasonably resulting in improved survival of a cancer patient.
In this case, both improved proteinuria levels and eGFR might reasonably suggest the spuds are working better.
Dimerix’s phase III trial, Action3, pertains to the rare kidney disease focal segment glomerulosclerosis (FSGS).
The company says that given the study is collecting both proteinuria and eGFR data over the last two years, no changes are required to the conduct or structure of the study.
The definition of endpoints is crucial in a trial and many drug candidates have gone to God by pursuing inappropriate ones.
The company also reports that to date 129 patients have ben randomised (split into active and placebo groups) and dosed, with 16 in the screening process.
In mid 2025 the company plans to release the blinded interim analysis of the first 144 patients after 35 weeks’ treatment.
Dimerix intends to request a meeting with the FDA to reach agreement on the appropriate proteinuria endpoints.
Dimerix shares were 2.35 lower at 41 cents.
Imagion Biosystems (ASX:IBX) says it will use the proceeds of a $3 million capital raising to kick-start its groundwork for a phase II study of its molecular imaging technology in the second half of 2025.
The company will dust off an Investigational New Drug (IND) application to the FDA, which will trial the ability of its of Magsense device to detect Her2-positive breast cancer.
“Additionally, [the] funds will be used to commence the IND process for at least one of the imaging agents in the research and development pipeline, targeting prostate and ovarian cancers,” the company says.
The funds emanate from the company’s recently-appointed lead broker, CPS Capital.
In October Imagion said it had received $3 million of firm commitments for a two-tranche share placement, with the second stanza subject to shareholder approval at an EGM to be held in early December.
Imagion CEO Bob Proulx said the company had only targeted $2 million, so was chuffed with the outcome.
Magsense offers better cancer imaging relative to the current techniques of magnetic resonance imaging (MRI), computed tomography (CT), X-Rays, ultrasounds and positron emission tomography (PET).
Magsense involves injecting nanoparticles labelled with cell-specific targeting antibodies, contained within an iron oxide solution.
The technology, believe it or not, is known as super-paramagnetic relaxometry – which sounds like something advertised in a Nimbin shopfront.
The nanoparticles are subject to a low magnetic pulse, with their location detected by an ultra-sensitive super-conducting quantum interference device.
Yep, that’s a SQUID.
Imagion’s September quarter released this morning shows the company had a thin cash balance of $386,000, although it managed to sustain the cost cutting initiated in the first and second quarters.
At an august EGM shareholders voted in favour of a restructuring a convertible financing facility from Mercer Street capital.
The new deal included extending the maturity date of existing convertible notes and establishing a new floor conversion price “better aligned with the company’s recent share price”.
Imagion shares were 2% lower at 5 cents.
At Stockhead, we tell it as it is. While Imagion and Dimerix are Stockhead advertisers, they did not sponsor this article.