ASX Health Stocks: Clinical trials gather pace for Visioneering Tech, Anteris and other biotechs
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is falling by 0.3% at the time of writing, compared to the broader index which is down by 0.37%.
Visioneering Technologies (ASX:VTI) has enrolled the first patient in its landmark international clinical trial to test its NaturalVue Multifocal Contact Lenses in children with myopia.
The study will enrol 144 healthy nearsighted children (myopes) of 7 to 13 years of age, whose current prescription is between -0.75D and -5.00D.
The study will be held across centres in Canada, the United States, and Hong Kong.
Participants will be randomly assigned to wear NaturalVue Sphere single vision contact lenses, and one-year follow up data is expected to be released mid-2023, with longer-term data expected mid-2024 and mid-2025.
“With 2 billion myopes in the world, and 5 billion expected by 2050, now is a prime time for VTI to be at the forefront of innovation, development, and clinical validation in this industry,” says VTI’s Chief Medical Officer, Dr. Ashley Tuan.
Heart specialist, Anteris Technologies (ASX:AVR), reported that its first-in-human DurAVR THV study has met or exceeded its interim study objectives.
At the 30-day follow up point, the first five patients showed no reported adverse events (no death, stroke, myocardial infarction, reintervention).
The company’s DurAVR 3D single-piece aortic heart valve replacement is said to be the next generation of TAVR devices that will last the life of an aortic stenosis patient.
“All signs continue to point to success in our mission of making available a TAVR that works better from the get-go and lasts longer,” Anteris Chief Medical Officer, Dr Chris Meduri (the study leader), commented.
The company is expected to continue to report results of the ongoing study throughout 2022.
Cannabis play Bod Australia (ASX:BOD) has secured an ethics approval for the Phase IIB clinical trial for its new Schedule 3 CBD product for the Australian market.
The trial was approved by the Bellberry Ethics Committee, and will study CBD effects on insomnia in 200 participants over 8 weeks.
If successful, the Phase IIB study will provide sufficient data for application to register a low dose CBD product with the TGA.
Bod is one of the first Australian companies to undertake a clinical trial for Schedule 3 CBD products, and expects to have one of the first products in market in the country.
Oncology specialist Patrys Ltd (ASX:PAB) was smashed 20% today, after reporting that the purification of its lead drug PAT-DX1 from the cell harvest has resulted in lower drug product recoveries than expected.
In view of this, Patrys is currently working with its manufacturing partner to implement improvements for the large-scale purification process, with a new improved process expected in Q2.
This development has resulted in a six month delay of the first in human study of PAT-DX1, which is now planned for mid-2023.
Living Cell Technologies (ASX:LCT) has signed an agreement with New Zealand biotech NZeno to obtain tissue from pathogen-free pigs for its third clinical trial of NTCELL in Parkinson’s disease.
The NTCELL clinical trial will study patients with early-mid stage Parkinson’s disease, and is the first xeno-transplantation trial carried out in Australia after earlier NZ trials.
Argenica Therapeutics (ASX:AGN) says it has completed preliminary pre-clinical toxicology and genotoxicity studies of ARG-007 under non-Good Laboratory Practice (non-GLP) conditions.
The toxicology studies have identified the parameters to estimate the safe starting dose for ARG-007 for the Phase 1 clinical trial.
ARG-007 is a novel therapeutic to reduce brain tissue death after stroke and improve patient outcomes.
Radiopharm Theranostics (ASX:RAD) has acquired full intellectual property (IP) ownership to three assets to target the treatment of a range of solid tumours.
Radiopharm will acquire the patents to three different nanobodies from NanoMab, targeting HER-2 (breast cancer), TROP-2 (triple negative breast cancer, or TNBC) and PTK7 (multiple solid tumours) for US$500k.
Digital health provider Adherium (ASX:ADR) has been confirmed as a medical devices manufacturer of inhaler dose sensors in the UK, after receiving a regulatory approval.
The company says the UK is an important target market for Adherium’s products, with over 5 million people currently receiving treatment for asthma, and about 900 thousand diagnosed with chronic obstructive pulmonary disease.
Adherium’s lead product is Hailie, a smart inhaler device that uses Bluetooth-enabled sensors to record and provide feedback to patients via the Hailie app.
Another health app specialist, ResApp Health Limited (ASX:RAP), announced that its ResAppDx acute respiratory diagnostic test has been successfully implemented and gone live on Doctors on Demand’s online telehealth platform in Australia.
Launched in 2015, Doctors on Demand offers virtual primary care supported by over 4,000 pharmacies for prescription fulfilment.
Clinuvel Pharma (ASX:CUV) says it has entered into a second agreement with the German National Association of Statutory Health Insurance Funds for the ongoing treatment and reimbursement of SCENESSE in adult erythropoietic protoporphyria (EPP) patients.
SCENESSE is currently the only approved treatment for adult EPP patients in Europe.
Cyclopharm Limited (ASX: CYC) says FY21 record revenues expected in range of $17.5-18 million, driven by growth in sales of Technegas generators, Technegas consumables, as well as third party distribution income.
A US FDA approval process is also on track, with an update meeting scheduled 27 January.
Telix Pharmaceuticals (ASX:TLX) has dropped 11.75% after announcing a $175 million placement and a $25 million share purchase plan.
The company said the funds will be used to execute on its late- stage clinical product pipeline, and advance multiple programs towards commercialisation particularly the ProstACT (prostate cancer therapy) clinical program.