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Health & Biotech
The year is ending with a bang rather than a whimper in biotech land, with a steady flow of clinical trials news likely to continue right up to Santa’s visit.
Today, immunotherapy house Immutep (ASX:IMM) said phase I results for one of its key molecules showed no safety or toxicity issues – and if a drug doesn’t kill you, it’s a good start.
PYC Therapeutics (ASX:PYC) yesterday updated investors on its program for the rare genetic disorder Phelan-McDermid syndrome.
Tomorrow, Percheron Therapeutics (ASX:PER) should release eagerly awaited results of its phase 2b trial for Duchenne muscular dystrophy.
In the case of Immutep, the first-in-human trial evaluated IMP-761, which the company claims to be the world’s first LAG-3 (lymphocyte-activation gene-3) agonist.
IMP-761 aims to enhance LAG-3’s action of putting a ‘brake’ on the production of rogue T-cells that cause disease. Other immunotherapy agents act as ‘accelerators’, so just make sure you don’t have your feet on both or you will burn out the clutch.
IMP-761 is thus a promising agent for autoimmune diseases such as rheumatoid arthritis, type-1 diabetes and multiple sclerosis.
Carried out in the Netherlands, the placebo-controlled, double-blinded study aims to assess up to 49 healthy participants.
“Given that IMP-761 is potentially addressing the root cause of many different autoimmune diseases, we are eager to see this study generating more data,” says Immutep chief scientific officer Dr. Frédéric Triebel.
Meanwhile, PYC and Percheron are pursuing similar paediatric neurological diseases as the $1.6 billion market cap Neuren Pharmaceuticals (ASX:NEU) .
With Percheron, Duchenne muscular dystrophy is a genetic condition that affects about one in 10,000 males (or 300,000 in all).
The disease results from a gene mutation, which affects production of the muscle protein dystrophin, causing movement-related muscle damage leading to chronic inflammation and progressive loss of function.
Tomorrow’s data pertains to top-line results from a phase IIb trial, which in May completed enrolling 48 wheelchair-bound boys across 16 hospitals in five countries.
Percheron’s candidate ATL-1102 “exerts an immune-modulatory effect which may be therapeutic in a range of inflammatory diseases”.
That is the hope, anyway.
Yesterday, PYC said pre-clinical animal studies of its drug candidate PYC-002 addressed the “underlying cause” of Phelan-McDermid syndrome, with human trials expected in 2026.
This one is a rare genetic disorder that presents at birth and causes problems such as delayed development, intellectual disability and delayed or absent speech.
Neuren has completed a phase II Phelan-McDermid trial and is engaged with the US Food & Drug Administration on the next step.
Apart from its commercialised drug for Rett syndrome, the program is Neuren’s most advanced clinical effort.
Immutep shares lost 1.5% to 34 cents and PYC shares were steady at $1.43.
Percheron shares are on trading halt.
Control Bionics (ASX:CBL) ‘lucky number’ is reaping early rewards in the US, with an expected 15%-plus surge in December half sales year-on-year, driven by take-up of the company’s flagship Neuronode assistive tech device.
Just to explain, the magic digits are E2513 – the US Medicare reimbursement code recently attributed to Neuronode.
Neuronode is a watch-like device to assist cognitive people with physical disabilities – notably sufferers of cerebral palsy or motor neuron disease – to perform everyday functions.
The code enables Neuronode to be sold as a stand-alone device at the attractive reimbursement rate of US$4300 ($6600) per unit.
In its business update today, the company also reports ongoing local problems with slow processing of NDIS invoices.
The company has $1.2 million of billings awaiting approval, or about to be lodged.
In what could be a statement or a plea, the company says: “the [government] has promised to resolve processing issues by early 2025.”
Despite that, Australian December (first) half sales are expected to increase by more than 20%, relative to the June half.
The company’s US sales were bolstered by the signing-on of an unnamed US university, “the first of what we expect will be meaningful orders for our US subsidiary.”
The other pertinent news is that the US ops are expected to generate positive underlying earnings in December, the company’s strongest month there.
The company has slashed $700,000 of annual costs from its US division, which is expected to shine through in the June 2025 half as well.
Control Bionics shares were unchanged at 6.6 cents.
Speaking of US reimbursement, Botanix Pharmaceuticals (ASX:BOT) reports the first prescription doses of its Sofdra anti-sweating treatment have been shipped to patients that were diagnosed via telemedicine and cleared by their insurers.
Sofdra tackles hyperhidrosis, which is excessive sweating well beyond the body’s need to stay cool.
The FDA approved Sofdra last year, with a full launch planned in the March quarter.
Ahead of that, the company says Sofdra prescriptions “are already being reimbursed in line with the pricing and restrictions previously contracted or negotiated with payers.”
In other words: insurance coverage has “unfolded as anticipated.”
Botanix shares fell 1.3% to 37.5 cents.
At Stockhead, we tell it as it is. While Control Bionics is a Stockhead advertiser, the company did not sponsor this article
Health & Biotech
Health & Biotech
Health & Biotech
