Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) will partner with Netherlands based biotechnology company Treeway BV to commercialise a new therapy to treat Amyotrophic Lateral Sclerosis (ALS) – the most common form of Motor Neurone Disease (MND) – in Australia and New Zealand.

The therapy is known as TW001 and is a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS. TW001 is currently being evaluated in the pivotal ADORE phase III registration study at almost 40 global sites.

Australian neurologist Associate Professor Susan Mathers said around 2000 people were living with MND at any one time in Australia, and an oral therapy like edaravone presented the opportunity for patients to be managed at home.

Associate Professor Mathers commented: “Better disease modifying therapies are urgently needed to slow and potentially halt this disease. Oral therapies like edaravone present the opportunity for a simple to manage therapy which can be taken at home and monitored through each person’s local health care provider.”

And key patient advocacy body MND Australia is also welcoming the potential for this new oral treatment option.

Executive Director, Research Gethin Thomas commented: “Oral edaravone would complement the recent approval of intravenous edaravone in Australia and broaden the patient base able to access treatment.”

Under the terms of the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001 for ALS/MND in Australia and New Zealand.

Announcing the partnership, ST Chief Executive Officer Carlo Montagner said TW001 was the first central nervous system (CNS) therapy to be included in the company’s therapeutic portfolio and the arrangement was further endorsement of ST’s regional capabilities and focus on making available in this region unique therapies that would otherwise not be accessible.

“We are delighted to partner with Treeway as this promising treatment progresses through the final stages of the pivotal global registration ADORE study,” he said. “We look forward to working with the wider MND community, who are determined to access new therapies to treat this terrible disease. “While there is still no cure for MND, we remain hopeful that new therapies such as TW001 may help to slow disease progression and improve outcomes.”

Treeway CEO Inez de Greef commented: “This important therapy has shown very encouraging results in all studies to date. We look forward to further results from the ADORE study and then working with ST to make our therapy available for all eligible patients in Australia and New Zealand who may benefit. ST is focussing on bringing new therapies to the market for diseases with a high medical need and therefore ST fits well as a licensing partner for Treeway.”