• Paradigm Biopharma demonstrates efficacy of knee osteoarthritis drug
  • Race Oncology released a third-party report showing the potential for Zantrene
  • Emyria and Aspen Australia have signed an exclusive binding deal


Paradigm Biopharmaceuticals (ASX:PAR) demonstrated that injectable pentosan polysulfate sodium (iPPS) may slow disease progression in knee osteoarthritis (OA).

Day 168 data from Paradigm’s Phase 2 PARA_OA_008 Clinical Trial shows a 21% improvement in the mean cartilage loss score, compared to 4% worsening in the placebo group.

Results also show statistically significant reductions in bone marrow edema lesions compared to placebo, and a reduction of marginal osteophytes compared to an increase in the placebo group.

Further data shows persistent positive clinical responses in the WOMAC pain score, and indicates potential for iPPS in knee OA treatment supported by trends in four key biomarkers (ARGS, COMP, C2C, and CTX-II) evaluated in this Phase 2 study.

Given the small sample sizes in this study, variability is expected, however the signals identified are consistent and support DMOAD (disease modifying OA drug) mechanisms.

Moving forward, Paradigm says it will work to establish the clinical and regulatory characterisation of these findings to define a pathway for iPPS in a larger clinical trial program.

Osteoarthritis is the most prevalent form of arthritis, with the risk of developing OA rising with age.

In the US, arthritis-attributable medical expenditures reached almost US$140 billion, which when combined with wage losses, totalled losses of over US$303 billion.

“A non-opioid drug for treating the symptoms of osteoarthritis with durability of effect out to 168 days, plus signals of disease modifying potential, is well poised to address a major unmet medical need,” said Paradigm CEO and chairman, Paul Rennie.

“These data are expected to assist our partnering discussions.”


Race Oncology releases third party report on Zantrene

Race Oncology (ASX:RAC) jumped 8% after releasing a summary of market research which was commissioned to better understand the commercial potential for lead asset, Zantrene, as a cardio-protective and anti-cancer agent.

Race Oncology recently engaged the Triangle Insights Group, which said in its report that Zantrene is well-positioned for use in metastatic breast cancer broadly, and within the neoadjuvant setting for HR+/HER2-, and triple negative breast cancer (HR-/HER2-).

In a pre-clinical research program, Race’s lead asset Zantrene was shown to protect heart muscle cells from anthracycline induced cell death, while improving the killing of breast cancer cells.

Anthracyclines are one of the most effective anti-cancer treatments ever developed, and are currently used in more cancer settings than any other class of chemotherapeutic agent, but high doses can cause side effects that include heart disease, and sometimes even irreversible heart failure.

The report by Triangle Insights concluded that there is a significant opportunity for Zantrene, which could be >US$5 billion if anti-cancer efficacy is demonstrated, or ~US$1 billion as a supportive care cardio-protective therapeutic.


Emyria signs supply deal wth Aspen Australia

Emyria (ASX:EMD) and Aspen Australia have signed an exclusive binding licensing and commercialisation term sheet agreement for the licensing and commercialisation of EMD-RX5.

Under the deal, Emyria will receive a royalty of up to 10% based on annual net sales, with aggregate milestone payments of $400k for satisfying agreed milestones.

EMD-RX5 is Emyria’s first, ultra-pure CBD capsule targeting TGA registration as an over-the-counter (OTC) treatment for the symptoms of mild stress and anxiety for patients with a chronic health condition.

The drug is is currently in Phase 3 clinical trials and aiming to be the first to market. It is a solid capsule form medication, a preferred dosage form for patients and prescribers.

Aspen Australia meanwhile is a subsidiary of South African listed Aspen Holdings (JSE:ASP), and has a comprehensive portfolio of over 140 brands of both Prescription and OTC medicines.

The company has full GMP manufacturing capabilities at its site in Dandenong, Victoria and will retain the rights to evaluate the opportunity to manufacture EMD-RX5 locally.

Going forward, both Aspen and Emyria will negotiate in good faith to explore OTC market opportunities in other countries in which Aspen operates.


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