• Botanix submits NDA to the US FDA
  • Pharmaxis reports on latest clinical trials
  • PainChek to expand to Japan

Clinical dermatology company Botanix Pharma (ASX:BOT) has submitted a New Drug Application (NDA) to the US FDA for Sofpironium Bromide for patients with severe primary axillary hyperhidrosis.

The submission follows the successful results from its Cardigan Phase 3 clinical trials, which demonstrated highly statistically significant clinical efficacy and safety.

More than 700 patients were enrolled in the two Phase 3 studies, and approximately 300 patients participated in a separate 48-week safety study of Sofpironium Bromide.

There were no treatment-related serious adverse events in any of the studies, and adverse events were transient and mild to moderate in nature.

Sofpironium Bromide is a topically applied gel which was designed to treat primary axillary hyperhidrosis – a medical condition which causes excessive underarm sweating.

In the US alone, there’s some 7.3 million subjects who suffer severe primary axillary hyperhidrosis, while some 3.7 million of them are actively seeking treatment.

PainChek expands to Japan

Smart phone-based pain assessment app specialist PainChek (ASX:PCK) meanwhile will expand its footprints to Japan after being accepted into the JETRO Business Connect program for 2022 .

JETRO is Japan’s core governmental organisation for promoting inbound foreign business.

As part of its program, PainChek will receive comprehensive support services to enter the Japanese market.

This includes a broad range of Japan market data, a series of online business matching events connecting PainChek with local partners throughout Japan, and guidance in relation to the Japanese regulatory clearance processes.

With an ageing population where almost a third of the population is 65 or older, the highest among all countries globally, PainChek believes there is an excellent opportunity within the Japanese market.

“This new initiative combined with our recent contact with FDA means PainChek can now plan effectively for market entry into the USA and Japan – two of the world’s largest medical device and aged care markets,” said PainCheck CEO, Philip Daffas.

Pharmaxis announces clinical trial data

Pharmaxis (ASX:PXS) has today announced interim data from the clinical trial of its topical anti scarring drug PXS‐6302 being conducted by the University of Western Australia (UWA).

The trial is headed by Professor Fiona Wood, the surgeon named Australian of the Year in 2005 for her work with the Bali bombing patients.

The trial, known as SOLARIA2, enrolled 50 adult patients treated daily for scars of greater than one year, and over 10cm2 in size for a period of 3 months.

Professor Wood commented on the results:

“We have noted positive changes in appearance and pliability of scars in those patients on active drug that now need to be confirmed by the results from the placebo controlled phase of this trial later this year.

“We are learning a lot as we move from the promising pre-clinical work done at UWA and into the clinic where we have many patients who are in great need of a treatment that can improve both the cosmetic appearance of their scars and improve the functionality of their scarred skin; factors that have a huge impact on patient’s wellbeing.”

Final results are expected in H1 2023.

Emyria expands clinical sites in Australia

Emyria (ASX:EMD) has expanded clinical sites for its EMD-RX5 Phase 3 trial.

The company has now qualified 8 clinical trial sites across Australia to support the pivotal trial of EMD-RX5, its first Ultra-Pure cannabinoid (CBD) treatment.

The clinical trial is now available to patients across Western Australia, Queensland, New South Wales, South Australia and the Australian Capital Territory

EMD-RX5 was created with a proprietary formulation that improves the delivery of CBD and supports global registration opportunities where exceptional purity is a requirement.

It has multiple indication potential, and is initially seeking registration with the TGA as a Schedule 3 over-the-counter treatment for symptoms of psychological distress.

Government grant for Cynata’s Cymerus MSCs

The Australian Government National Health and Medical Research Council (NHMRC) has awarded a grant of approximately $1 million to fund the research into Cynata Therepeutics (ASX:CYP) Cymerus MSCs (mesenchymal stem cells).

The Medical Research Future Fund (MRFF) grant was awarded to St. Vincent’s Institute of Medical Research in Melbourne (SVIMR).

The Cymerus MSCs were created to treat ischaemic heart disease (IHD), the leading cause of heart failure and death worldwide.

Previous studies showed that Cymerus MSCs have multiple positive effects in a preclinical model of IHD/heart attacks.

Dr Shiang Lim, Head of Cardiac Regeneration Laboratory at SVIMR said: “We firmly believe that MSC therapy has great potential to address this unmet need.

“Unlike conventional stem cell production methods, which are associated with scale up and consistency challenges, the Cymerus iPSC-based approach can provide an effectively unlimited source of consistent MSCs.”


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