Clinical Trials Tracker: 2022 and beyond

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.

Last week, we published all the trials under way or proposed for 2021.

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.

Second-quarter 2022

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.

2022

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.

Pharmaxis (ASX:PXS) – phase 1/2 clinical trial evaluating the company’s drug candidate PXS-5505 in the treatment of 24 patients with myelofibrosis, a bone marrow cancer.

Telix Pharmaceuticals (ASX:TLX)– phase 2 trial evaluating if Telix’s diagnostic research agent can show prostate cancer on a PET/CT scan even when PSA levels are very low.

Late 2022

Kazia Therapeutics (ASX:KZA) – phase 1 trial assessing its paxalisib in combination with radiation therapy in 36 patients with solid brain tumours.

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.

First-quarter 2023

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

Chimeric Therapeutics (ASX:CHM) – phase 1 dose escalation study of the newly listed CAR T company’s cell study in approximately 18 patients with glioblastoma, an aggressive brain tumour.

Cynata Therapeutics (ASX:CYP)– phase 3 SCUlpTOR clinical trial evaluating Cynata’s CYP-004 stem cell infusion in up to 440 Australian patients with osteoarthritis of the knee.

Late 2023

Mesoblast (ASX:MSB) – phase 1b/2a study testing remestemcel-L stem cell infusions in 24 patients with Crohn’s colitis.

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.

Antara Lifesciences (ASX:ANR) said in December it is planning a study evaluating its colon-targeted formulation in adults with depression or anxiety.

Auscann (ASX:AC8) says an investigator-led phase 2a study into its hard-shell cannabis capsules to treat chronic neuropathic pain is expected to begin in the second quarter of 2021.

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.

Immuron (ASX:IMC) has two clinical trials planned to evaluate the efficacy of its drug in moderate to severe campylobacteriosis and infectious diarrhea caused by e.coli bacteria.

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.

Medlab Clinical (ASX:MDC) is preparing for a phase 3 trial to study the use of its cannabis-based NanBis formulation to treat cancer-induced bone pain, and expects to begin recruitment this year.

MGC Pharma (ASX:MXC) said in December it was evaluating holding a phase 3 trial testing the use of its ArtemiC anti-inflammatory treatment, following a successful phase 2 trial.

Neurotech (ASX:NTI) plans in the first quarter of 2021 to begin phase 1 clinical trials evaluating compounds from its novel Dolce/NTI strains of hemp to treat neurological disorders.

Neuroscientific Biopharmaceuticals (ASX:NSB) has said it plans this year to begin two phase 1 studies evaluating its regenerative peptide, EmtinB, in both ocular and neurology conditions.

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.

Patrys (ASX:PAB) said in November it expects to begin a phase 1 clinical trial into its PAT-DX1 anticancer antibody drug candidate in the first half of 2022.

PharmAust (ASX:PAA) said in December that in October 2021 it would begin a phase 1/2 clinical trial evaluating the use of monepantel to treat motor neuron diseases such as Lou Gehrig’s disease/ALS.

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.

Vectus Biosystems (ASX:VBS) said in November it had hired Syneos Health (NASDAQ:SYNH) to conduct a phase 1 safety study of its VB0004 drug candidate to treat fibrosis.

At Stockhead we tell it like it is. While Dimerix, Neuroscientific, Neurotech and Incannex are Stockhead advertisers, they did not sponsor this article.