LONDON (ShareCast) - (Sharecast News) - Clinical-stage biotherapeutics company PureTech Health announced on Tuesday that the first participant has been dosed in a clinical study of 'LYT-100', its wholly-owned product candidate for the potential treatment of lymphoedema and other fibrotic conditions.
The FTSE 250 company said there were currently no FDA-approved drugs to treat lymphoedema, which it described as a painful, progressive, and chronic condition that affected around one million individuals in the US alone, including about 500,000 breast cancer survivors.

It said the phase 1, multiple ascending dose and food effect study was designed to evaluate the safety, tolerability and pharmacokinetic profile of LYT-100 in healthy participants.

The study would be a follow-up to the single ascending dose clinical trial of LYT-100 in healthy individuals that was conducted by Auspex.

Results from the multiple ascending dose study were expected in the current year, and would enable the initiation of a proof-of-concept study in people with breast cancer-related, upper limb secondary lymphoedema later in 2020.

"Lymphatic diseases cause significant disability and pain, yet there are few meaningful treatment options, most of which involve compression and physical therapy to control swelling," said PureTech's advisor Dr Babak Mehrara, who is the chief of the plastic and reconstructive surgical service at the Memorial Sloan Kettering Cancer Center.

"LYT-100 is designed to address the underlying cause of lymphoedema by reducing fibrosis and inflammation and restoring lymphatic function, and I believe it holds tremendous potential as a therapeutic candidate for the treatment of lymphoedema."

PureTech said LYT-100 is an oral, small molecule drug candidate known as 'deupirfenidone', which had demonstrated preclinical anti-fibrotic and anti-inflammatory activity.

It was previously studied in healthy volunteers as part of a phase 1 single-dose study, and was observed to be well-tolerated with a favourable pharmacokinetic profile that could support twice daily oral dosing.

LYT-100 is the first clinical programme in PureTech's wholly-owned pipeline, which was focused on harnessing the lymphatic system and related immunology mechanisms for the treatment of cancer, immunological, lymphatic and central nervous system-related disorders.

"Our model at PureTech has always been to identify, invent and advance novel therapeutics," said co-founder and chief executive officer Daphne Zohar.

"We work with the world's leading experts in a discovery process that breaks down specific diseases and comprehensively reviews and empirically tests unpublished scientific discoveries in a modality agnostic and unbiased way."

Zohar said that approach had enabled the firm to "rapidly convert" findings into therapeutic product candidates, which historically had been housed in subsidiaries.

"The advancement of LYT-100 is another example of executing on our strategy to develop a therapeutic solution for significant need, though this time the product candidate will continue to be wholly owned by PureTech."

At 0805 GMT, shares in PureTech Health were up 1.63% at 307.93p.

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