LONDON (ShareCast) - (Sharecast News) - PureTech Health announced plans on Thursday to advance its wholly-owned clinical-stage product candidate 'LYT-100', or deupirfenidone, as a potential treatment for serious respiratory complications, including inflammation and fibrosis, that persist following the resolution of Covid-19 infection.
The FTSE 250 clinical stage biotherapeutics company said LYT-100 employed a "multimodal mechanism of action" to potentially reduce, delay or prevent the lung dysfunction that had recently been documented in Covid-19 patients, including those who had recovered from the infection.

It said a global, randomised, placebo-controlled trial was expected to begin in the third quarter, and would evaluate LYT-100 in non-critical Covid-19 patients with respiratory complications for up to three months.

"Hundreds of clinical trials are underway to combat Covid-19, but the vast majority are focused on vaccines or the acute treatment of severe patients," said Dennis Ausiello, former chief of medicine at Massachusetts General Hospital and a member of the PureTech research and development committee.

"As we learn more about the full impact of Covid-19 on the body, we're seeing post-recovery, longer-term pulmonary dysfunction similar to that observed following infection with other coronaviruses, including SARS and MERS."

Sr Ausiello noted that emerging data suggested that a "high proportion" of Covid-19 patients were at risk of impaired lung function and fibrosis after recovery, as well as during acute infection.

"With more than five million documented infections to date worldwide, there is a clear and urgent need for therapeutics to address the longer-term sequelae of Covid-19."

PureTech said LYT-100 is an oral anti-fibrotic and anti-inflammatory small molecule, and a deuterated analogue of pirfenidone.

Oral pirfenidone is approved for the treatment of idiopathic pulmonary fibrosis in the United States, the European Union, Japan and a number of other countries, and has received breakthrough therapy designation from the FDA for unclassifiable interstitial lung disease.

In prior phase 1 healthy volunteer studies, LYT-100 reportedly showed a "differentiated and superior" pharmacokinetic profile compared to pirfenidone, suggesting improved efficacy, tolerability and safety, while retaining the same intrinsic pharmacology of pirfenidone.

Preclinical research also showed that LYT-100 "potently inhibits" a range of pro-inflammatory cytokines including IL6, TNF alpha and TGF-beta.

"PureTech has always been driven to help patients through innovation in medicine, and our LYT-100 programme in Covid-19 represents another example of this commitment," said PureTech's chief innovation officer Eric Elenko.

"The unique anti-fibrotic and anti-inflammatory properties of LYT-100 may have therapeutic potential in a range of conditions, including other interstitial lung diseases as well as lymphoedema, for which a trial is planned to begin in 2020."

PureTech said it expected to initiate a global, multi-centre, randomised, double-blinded, placebo-controlled trial in the third quarter to evaluate the efficacy, safety and tolerability of LYT-100 in non-critical Covid-19 patients with respiratory complications.

Patients would continue treatment for up to three months, and the trial was expected to enrol around 150 patients, with a primary endpoint measuring pulmonary function testing.

The trial would also assess exploratory endpoints including pharmacokinetics, acute inflammatory biomarkers, hospitalisation events, imaging and patient-reported outcomes.

PureTech said it expected to announce topline results in mid-2021.

As it had previously announced, in March the company initiated a phase 1 trial of LYT-100 evaluating its safety, tolerability and the pharmacokinetic profile of multiple doses in healthy participants.

Results from that trial were expected later in the year, and a subsequent proof-of-concept trial in people with breast cancer-related upper limb secondary lymphoedema was set to begin in 2020, with topline results expected in 2021.

PureTech said it was also evaluating additional inflammatory and fibrotic conditions that could potentially be addressed with LYT-100.

At 1008 BST, shares in PureTech Health were down 1.8% at 245.5p.

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