Clinical Trials Tracker: 2022 and beyond
Health & Biotech
Keeping track of all that’s going on with clinical trials in the sector and on the ASX can be tricky. Until now.
As life sciences investors know, clinical research is what drives success or failure for biopharmaceutical companies.
Welcome to Stockhead’s inaugural clinical trials tracker – an effort to list the clinical trials underway and planned in the near term for nearly every ASX-listed life sciences company.
As a small-cap publication, we’ve excluded research by CSL (ASX:CSL) from this tracker. Readers interested in the 25 different clinical trials underway by the $122 billion blood products giant can find a list here.
We also don’t include pre-clinical research such as that conducted on animals or human cells in a test tube (in vivo and in vitro tests).
Today, for those who like a longer view, we’ve pulled together the best idea we can of those trials slated for 2022-2025.
Here’s your look into our medical future.
Clinical Trials Tracker: First-quarter 2022
Noxopharm (ASX:NOX) – interim results from the DARRT-2 phase 2 study evaluating escalating doses of Noxopharm’s Veyonda suppository in conjunction with radiotherapy to induce an anti-cancer immunological response in 100 to 150 cancer patients.
Hexima (ASX:HXL) – Phase 2b clinical trial testing its plant defensin peptide HXP-124 in 132 Australian and New Zealand patients with toenail fungal infections (onychomycosis). Coronavirus travel restrictions have delayed enrollment in the trial, with results are now expected in the second quarter of next year. Hexima listed in December 2020.
AdAlta (ASX:1AD) – phase 1 clinical trial testing the Melbourne biotech’s AD-214 drug candidate – which mimics a protein first found in sharks – in about 98 patients with interstitial lung disease. Dosing of 34 healthy volunteers finished in December.
Ecofibre (ASX:EOF) – phase 2 “Coala-T-CBD” study, testing the effect of CBD gelcaps on up 100 patients suffering from chemotherapy-induced peripheral neuropathy (CIPN), a painful common side effect from the cancer treatment. Ecofibre says the research, being conducted at the Lankenau Institute for Medical Research in Philadelphia, USA, is the first in the United States to study the impact of hemp-derived full-spectrum CBD on CIPN.
Clinical Trials Tracker: 2022/2023
Kazia – Results from the paxalisib arm of GBM AGILE study, which is assessing new therapies for the aggressive brain cancer glioblastoma. Up to 200 patients will be treated with paxalisib, and these will be compared to a roughly similar number of patients in a control group. Kazia said in January 2021 that the enrollment was expected to last 30 to 36 months, although the study could conclude earlier.
Paradigm Biopharmaceuticals (ASX:PAR) – phase 3 study evaluating Zilosul in patients with osteoarthritis. The study will recruit from up to 55 sites in the USA and up to 10 in Australia.
Clinical Trials Tracker: 2023
Clinical Trials Tracker: 2024
Kazia – St Jude Children’s Research Hospital phase 1 study testing Kazia’s GDC-0084 drug in 27 pediatric patients with a high-grade brain tumour known as a diffuse intrinsic pontine glioma.
Clinical Trials Tracker: 2025
Kazia – phase 2 study testing Kazia’s PI3K inhibitor GDC-0084 in 150 patients with solid tumors that have spread to the brain.
Telix – Phase 2 trial evaluating the effectiveness of a PET/CT scan using fluciclovine in planning radiation therapy for patients with prostate cancer.
Clinical Trials Tracker: Studies planned to begin in 2021
Actinogen Medical (ASX:ACW) said in December it was planning to commence two phase 2 trials in the first half of 2021, testing Xanamem to treat mild cognitive impairment due to Alzheimer’s disease and anxiety, sleep and behavioral problems in adolescents with Selected Fragile X syndrome. The company’s lead compound, Xamamem blocks the production of a stress hormone in the brain.
Alterity Therapeutics (ASX:ATH) said in October it was working towards a phase 2 clinical trial evaluating its lead compound in the treatment of Multiple System Atrophy, a neurodegenerative disease similar to Parkinson’s.
Botanix Pharmaceuticals (ASX:BOT) has a phase 3 study planned into its BTX 1503 antimicrobial synthetic cannabis formulation to treat moderate to severe acne. The medical marijuana company has met with the FDA over the design of the study and says it is poised to begin once COVID-19 restrictions are lifted in Australia and New Zealand.
Botanix also said in December it plans to begin “in the near future” a phase 1b study evaluating its antimicrobial gel to treat rosacea, an inflammatory skin condition.
Dimerix (ASX:DXB) is planning for a phase 3 study of its drug candidate DMX-200 to treat a rare kidney disease known as focal segmental glomerulosclerosis, or FSGS. The trial is scheduled begin in the first half of 2021, with interim data due next year, and the results could form the basis of a new drug approval submission.
Incannex Healthcare (ASX:IHL) in December announced it was partnering with Monash University to conduct a world-first trial testing “magic mushrooms,” or psilocybin, to treat generalised anxiety disorder in 72 patients.
Invex Therapeutics (ASX:IXC) said in December it was planning a phase 3 study investigating the diabetes drug Exenatide to treat raised intracranial pressure, a condition that can cause debilitating headaches. The treatment passed a phase 2 clinical trial last year.
Noxopharm announced in November it was partnering with Bristol Myers Squibb (NYSE:BMY) to test its Veyonda suppository in conjunction with Bristol Myers’ nivolumab in 30 cancer patients. The first patients will be recruited early this year for the IONIC-1 study, but there’s been no word on how long it will last.
Opthea (ASX:OPT) plans to begin two phase 3 trials in early 2021 assessing OPT-302 to treat wet age-related mascular degeneration. Each trials will enroll at least 900 patients worldwide and follow them for two years, so would presumably read out in 2023.
Race Oncology (ASX:RAC) is investigating the cost and scope of a proof of concept phase 1/2 clinical trial testing its flagship drug Bisantrene in combination with the chemotherapy drug cyclophosphamide.
At Stockhead we tell it like it is. While Dimerix, Neuroscientific, Neurotech and Incannex are Stockhead advertisers, they did not sponsor this article.