Health Check: ASX biotechs strive to overcome the pain barrier | Stockhead
If pain persists, there are plenty of pills around. But pain management is screaming for better treatments. Pic: Getty Images. National Pain Week highlights the ubiquitous nature of the affliction – and the. . .
If pain persists, there are plenty of pills around. But pain management is screaming for better treatments. Pic: Getty Images. National Pain Week highlights the ubiquitous nature of the affliction – and the challenge for drug and device developersNo impediments as Impedimed eyes broader marketsAll the latest quarter time scores from around the groundsIt’s National Pain Week. Or for now-deposed Victorian premier Jacinta Allan, Localised Pain Day. According to Chronic Pain Australia, more than 5. 4 million of us live with the condition. For such a common ailment, new treatments have proved elusive. That leaves sufferers relying on the old drug classes: opioids like codeine and oxycodone, analgesics such as paracetamol, or nonsteroidal anti-inflammatory drugs such as ibuprofen. All of them have their drawbacks: they don’t work too well, they damage the kidneys or are potentially addictive. Clinical trials are difficult because of the subjective nature of the assessment and the ‘placebo effect’. But a handful of ASX biotechs are pursuing pain programs in various niche ways. Yesterday we mentionedMedical Developments International (ASX:MVP). The company has revived the old Penthrox, a non-opioid inhaler, known as the Green Whistle. Mesoblast (ASX:MSB)has a phase III stem cell candidate, for lower back pain caused by degenerative disc disease. Having listed last December, neuromodulation playSaluda Medical (ASX:SLD)has developed the Evoke spinal cord stimulation system. Evoke treats chronic back and leg pain by responding to the spinal cord’s neural activity. Paradigm Biopharmaceuticals (ASX:PAR)is repurposing pentosan polysulphate sodium (Zilosul), to treat knee osteoarthritis. The drug aims to reduce joint pain, while helping to improve and regenerate cartilage volume. The company expects to disclose interim results from its pivotal phase III trial next month. Yes – August, only a couple of days away. AFT Pharmaceuticals (ASX:AFP)(see below) has mastered a paracetamol and ibuprofen combo product, Maxigesic. And let’s not forgetPainchek (ASX:PCK). The phone app developer doesn’t relieve pain, but detects it in the case of aged care residents unable to enunciate their discomfort. Medical pot growers and suppliers such asLittle Green Pharma (ASX:LGP),Cann Group (ASX:CAN)andBioxyne (ASX:BXN)don’t cater to specific indications. But users cite pain as a key reason for seeking a cannabis prescription. Good luck to all of these pain plays: the sector needs a win in this sector. Impedimed cuts costs, eyes wider marketsLymphoedema detection device makerImpediMed (ASX:IPD)has executed a $5 million cost-cutting drive to improve its bottom-line performance. “I’m pleased with the progress made on headcount and cost management,” new-ish CEO Erik Anderson said. “While this is never a simple task, aligning the entire organisation to the same goals … makes it crystal clear where we need to direct our spend to drive results. ”Impedimed reported June quarter revenue of $3. 6m, up 3% on the March quarter. Annual recurring revenue grew 2%, to $14. 4m. Sozo detects breast cancer-related lymphoedema, which in effect is fluid in limbs where it shouldn’t be. Sozos are based on bioimpedance spectroscopy (BIS). ImpediMed eyes expansion into heart health, body composition and weight management relating to using GLP-1 drugs. The company sold 36 of its devices – dubbed Sozos – in the quarter. Put in context, Impedimed has sold 642 Sozos to leading US hospitals, with agreements signed with 27 integrated delivery networks (hospital groups). After net operating cash outflows of $4. 9m, Impedimed had June-end cash of $15. 3m. The company raised $15. 3m and paid down $5m of debt. CEO Erik Anderson said the company was well placed in the lymphoedema sector, given improved cancer survivorship means patients need to be monitored for longer. Meanwhile, the Sozo Pro variant is the only US-approved BIS device for patients with cardiac implantable devices. The company estimates a US$600m-a-year addressable market for US outpatient heart failure fluid monitoring. An “urgent need to reduce readmissions and monitor body composition” will drive demand. About 6. 7 Americans have heart failure, with about one million new cases a year. Kwarterly KornerThe developer of a spray-based erectile dysfunction treatment,LTR Pharma (ASX:LTP)finished the quarter engorged with $19. 6m of cash, despite burning $4. 42m. LTR is developing Spontan for the local and US market and a variant, Roxus, for early US entry. “During the quarter we advanced our lead programs on two fronts: clinical validation and commercial execution,” exec chair Lee Rodne said. Phase II interim data from the Spontan trial reinforced the rapid absorption of the active agent vardenafil, relative to oral delivery. This applied especially for men over 65. “For Roxus, we secured the two-core US commercial partners supporting launch, covering telehealth and pharmacy fulfilment. ”Both term sheets then converted into definitive agreements. LTR targets a US Roxus launch this calendar year, by way of the US Food and Drug Administration’s Section 503A (personalised medicine) pathway. A relatively new entrant into the stem-cell sphere,Neuroscientific Biopharmaceuticals (ASX:NSB)reported end-of-quarter cash of $4. 6m. The company expended a tad over $1m during the period. The Perth-based company is girding for a phase II trial of its Stemsmart tech. Previously, four out of five patients treated under the local Special Access Scheme achieved a clinical response. Oncology drug developerPrescient Therapeutics (ASX:PTX)reported cash of a tad over $9m, having burnt through $2. 87m. Prescient has multiple programs, but investors are focused on the company’s ongoing phase IIa trial of PTX-100. PTX-100 targets T-cell lymphoma, either as a standalone or combination treatment. During the quarter the global study enrolled 14 more patients. With two more signing on post June, this takes the tally to 28 subjects out of the targeted 40. The company asserts PTX-100 is the world’s only GGTase-1 inhibitor in clinical development. Who are we to argue?AFT has (half) the world coveredSpecialty NZ-based drug maker AFT Pharmaceuticals says it is developing enough products to cover almost half the world’s markets – and we’re not talking Antarctica or North Korea. The aformentioned Maxigesic is AFT’s hero product. But at its research and development show-and-tell today, AFT said its development portfolio extended to eight patented projects and 24 off-patent injectables. The company also other projects in early commercialisation, “offering multi-billion-dollar addressable markets”. “In parallel, AFT is also developing and strengthening its business hubs in Australia, NZ, Singapore, Hong Kong, the US, Canada and the UK,” the company said. “For selected parts of the R&D portfolio [this] would allow AFT to cover up to 50% of the global market directly. ”AFT’s most important emerging product is an intravenous iron therapy to address the shortcomings of existing iron infusions. Currently in phase III, the product would enable patients to receive treatment in a single dose, rather than over multiple appointments. The company cites a potential US$7. 4 billion a year market. Meanwhile, AFT is developing room-temperature cream to treat port wine stain birthmarks, as well as facial angiofibromas associated with tuberous sclerosis complex. The company is also working on a treatment for infantile haemangioma (strawberry birthmarks). “Few pharmaceutical companies in New Zealand or Australia straddle both the development of intellectual property and the commercialisation of speciality medicines,” founder and CEO Dr Hartley Atkinson said. “Fewer still fund this growth largely from internally generated cashflows. AFT does both”. So there!At Stockhead, we tell it as it is. While LTR Pharma is a Stockhead advertiser, the company did not sponsor this article.