Clinical Trials Tracker: The tests ASX healthcare companies have upcoming in 2021
Health & Biotech
Health & Biotech
Link copied to
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, clinicial 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).
Given its size, Kazia Therapeutics (ASX:KZA), a $160 million Sydney company developing treatments for brain and ovarian cancer, was a standout in our tracker with the amount of research underway.
Kazia chief executive and executive director Dr James Garner told Stockhead that the Sydney company had eight different clincial trials in progress – seven in collaboration with world-renown organisations including the Dana-Farber Cancer Institute in Boston and the Memorial Sloan Kettering Cancer Center in New York City.
“We wanted to put into place a very international-grade research program,” to add value to Kazia’s assets while avoiding the trap some Australian biopharmaceutical companies run into of running from financing round to financing round, Dr Garner said.
Partnerships give Kazia the best “bang for the buck” even if the company loses some control over the process, he said.
Only one of Kazia’s clinical trials is explicitly designed as a “pivotal” study, meaning one that could be used to apply for a regulatory approval. But given that some of the research is into very rare pediatric brain cancers, regulators might accept the results of one of the smaller studies to progress a drug to market, Dr Garner said.
“As much as 2020 was a big year for Dimerix, 2021 is shaping up to be even bigger and our small but dedicated team look forward to hitting these key milestones,” chief executive Nina Webster told Stockhead.
Without further ado – here’s our inaugural ASX Clinical Trials Tracker.
Neuren Pharmaceuticals (ASX:NEU) – phase 1 trial evaluating the safety of its NNZ-2591 drug candidate in 16 healthy adult volunteers. Neuren plans to initiate phase 2 trials in 2021 evaluating use of the drug candidate to treat three serious neurodevelopmental disorders – Phelan-McDermid, Angelman and Pitt Hopkins syndromes.
Exopharm (ASX:EX1) – Plexovall II phase 1 study assessing the safety and biological activity of Exopharm’s Plexaris OS exosome treatment in wound healing following a skin punch biopsy in 11 healthy volunteers. Dosing is complete and the study volunteers are due for a follow-up in January with final results due in February, Exopharm said in December.
Noxopharm (ASX:NOX) – interim survival data from the LuPIN phase 2 study evaluating Noxopharm’s Veyonda suppository in 56 men with end-stage prostate cancer, when taken in conjunction with a Novartis radiopharmaceutical. The men have completed their treatment and the study will conclude in the third quarter.
Bionomics (ASX:BNO) – seven-day dosing study testing a solid dose formula of Bionomics’ lead drug candidate BNC210 in healthy volunteers. An earlier phase 2 study of the potential PTSD drug failed in 2018 because it involved a liquid formula that needed to be taken with food. A phase 2 study of the new tablet version of BNC210 is planned for mid-2021.
Botanix (ASX:BOT) – phase 2a study testing the company’s BTX 1801 antimicrobial to eradicate staph and MSRA germs from the nose of 60 healthy volunteers known to carry those bacteria in their nasal cavity. Botanix said on January 20 the study is complete and it expects to release top-line data “very early” in the first quarter.
Medlab Clinical (ASX:MDC) – readout for its NRGBiotic study investigating using a probiotic to treat depression in 120 patients, as well as for its MultiBiotic study testing use of the probiotic to prevent intestinal ulcers 30 patients.
Mesoblast – phase 3 trial evaluating the use of rexlemestrocel-L to treat chronic low back pain in 404 patients. The readout was expected last quarter but has not yet been announced.
Rhythm Biosciences (ASX:RHY) – “Study 6” evaluating the company’s ColoSTAT colorectal blood test against 200 patient samples. This study could be used to support a CE Mark application for European device approval, according to Rhythm.
Immutep (ASX:IMM) – Interim data from the investigator-initiated “EAT-COVID” phase 2 trial in the Czech Republic, testing Immutep’s lead drug candidate eftilagimod alpha (“efti”) to treat up to 110 hospitalised COVID-19 patients.
Noxopharm (ASX:NOX) – NOXCOVID-1 phase 1b dose-escalation study testing Noxopharm’s Nox66 drug candidate, given rectally to 40 hospitalised COVID-19 patients. If successful the study would be expanded to a phase 2/3 study.
Immutep – More data from TACTI-002 phase 2 study evaluating the biotech company’s flagship immunotherapy product, eftilagimod alpha (“efti”), in combination with Merck & Co’s Keytruda in about 109 patients with lung or head and neck cancer. Immutep reported promising interim data from the study in November and said on January 7 that it expects to release more data in the first half of the year.
Immutep – Results from INSIGHT-004, a phase 1 feasibility and safety study evaluating efti in combination with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancer tumours.
Incannex Healthcare (ASX:IHL) – phase 2b clinical trial testing Incannex’s medicinal cannabis formula IHL-42X to treat obstructive sleep apnoea in 30 patients. The study will be performed at Alfred Hospital and the company says a positive result “would be a major valuation inflection point for Incannex”.
Kazia – Publication of an academic study on its phase 1 study assessing the use of Cantrixil in 25 patients with ovarian cancer. Kazia released top-line final data in December but embargoed the full data set.
Kazia – Dana Farber Cancer Institute phase 2 clinical trial testing paxalisib in combination wtih Herceptin to treat up to 47 patients with HER2-positive metastatic breast cancer.
Kazia – St Jude Children’s Research Hospital phase 2 clinical trial testing paxalisib in 27 patients with a newly diagnosed brain tumour. Kazia presented interim data from the study in November that indicated paxalisib extended overall survival by several months, compared to the FDA-approved treatment, Temozolomide.
Prescient – phase 1/2 open-label study testing the company’s PTX-200 drug candidate in combination with chemotherapy to treat 40 leukemia patients.
Bionomics – phase 2 Modulate trial of the company’s cancer drug candidate, BNC105, in combination with Bristol Myer Squibb’s Opdivo to treat 90 patients with metastatic colorectal cancer. On January 20, Bionomics said the results would be ready in the second quarter of 2021, about two years ahead of schedule.
Amplia Therapeutics (ASX:ATX) – phase 1 clinical trial testing the company’s AMP945 drug candidate in 64 healthy volunteers. The company sees the focal adhesion kinase inhibitor as a treatment for both fibrosis and cancer.
Dimerix (ASX:DXB) – Results from the REMAP-CAP and CLARITY studies, which have included the Melbourne biotech’s DMX-200 compound in large-scale assessments of treatments for COVID-19 patients. If either study shows DMX-200 is safe and effective in treating seriously ill COVID patients, Dimerix could use that data to apply for an emergency use authorisation for the chemokine receptor (CCR2) blocker.
Immutep – Final overall survival data from its phase 2b AIPAC study comparing efti to chemotherapy in 241 breast cancer patients in Europe. Immutep has said this is a potentially pivotol trial, meaning it could be used to seek regulatory approval of efti in Europe and the United States.
Oncosil Medical (ASX:OSL) – PanCo pilot study evaluating the OncoSil radiation therapy device in 42 patients with advanced pancreatic cancer. Oncosil reported positive interim results from the study in October.
Neuren – Results from the phase 3 LAVENDER study of Neuren’s drug candidate trofinetide to treat 180 girls and young women with Rett syndrome, a rare and debilitating neurodevelopmental disorder. The study is being conducted by Neuren’s North American licensee, ACADIA Pharmaceuticals (NASDAQ:ACAD), and could form the basis for a new drug application in the United States. The study was paused during the pandemic, but Neuren said in October that results were expected in the second half of 2021.
Telix – phase 3 trial evaluating 89Zr-TLX250 as a diagnostic agent targeting clear cell renal cell carcinoma in 252 patients. Telix also has a phase 1/2 study examining the safety, tolerability and sensitivity of 89Zr-TLX250 in 40 patients
Clinuvel – Study assessing the effect of its drug Scenesse on DNA repair capacity in 10 healthy volunteers.
Imugene (ASX:IMU) – phase 2 trial of its HER-Vaxx cancer vaccine in 36 patients with advanced gastric cancer. The trial is being conducted in clinical sites across Asia, Eastern Europe and India, where clinicians have difficulty accessing treatments such as Herceptin and Perjeta.
Paradigm – phase 2 clinical trial testing pentosan polysulphate sodium injections in up to 10 patients with the ultra-rare orphan disease mucopolysaccharidosis type 1, which causes multiple developmental deformities.
Reece – Phase 1 study testing REECE 327 intravenously in 48 healthy adult volunteers.
Bionomics – phase 1 trial testing Bionomics’ BNC105P drug candidate in combination with Imbruvica to treat 15 patients with chronic lymphocytic leukemia (CLL).
Imugene – phase 1 clinical trial of its immunotherapy candidate, PD1-Vaxx, in 22 patients with non-small cell lung cancer. A cohort review committee allowed the dose-escalation study to go forward in January after the first three patients were given the lowest dose of the drug with no observed toxicity.
Medlab Clinical – Observational study of NanaBis, a cannabis-based treatment for cancer-induced bone pain. Medlab said in November 2020 that 668 participants of the desired 2,000 had been recruited for the study.
Rhythm Biosciences – “Study 7” evaluating the company’s ColoSTAT colorectal cancer test against over 1,000 patient samples. This study could be used to fulfil compulsory regulatory requirements in some markets, such as Australia, Rhythm says.
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 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 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 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 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.
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 Exopharm, Dimerix, Prescient Therapeutics, Neuroscientific, Neurotech and Incannex are Stockhead advertisers, they did not sponsor this article.