PureTech is repositioning an antifibrotic drug for use in the treatment of long-term lung dysfunction associated with COVID-19. The Boston-based biotech plans to start a trial in the emerging population of patients who survive COVID-19 only to suffer lasting damage in the third quarter.
So far, biopharma has primarily focused on either preventing cases of COVID-19 or treating patients with acute symptoms associated with infection. There is potentially another use case for medicines, though.
SARS and MERS, viruses related to the pandemic SARS-CoV-2, scarred the lungs of a significant minority of people who recovered from infection. The severity and duration of respiratory symptoms that some patients infected with SARS-CoV-2 suffer suggest such long-term damage may also happen in people who survive COVID-19. And, with 2.5 million people already recovered from COVID-19, there may be many people in that situation.
PureTech thinks it can address that emerging unmet need using LYT-100, which features a modified version of the pirfenidone active ingredient found in Roche’s idiopathic pulmonary fibrosis treatment Esbriet. Pirfenidone has antifibrotic and antiinflammatory effects, leading some researchers to posit that it could play a role in the response to COVID-19.
Yet, pirfenidone suffers from shortcomings including links to hepatotoxicity and a short half-life. In LYT-100, PureTech may have a drug that provides the efficacy of pirfenidone without the tolerability issues. LYT-100, also known as deupirfenidone, is a deuterium-substituted analogue of pirfenidone.
That thinking led PureTech to license the drug from Teva Pharmaceuticals, which acquired it in its $3.5 billion takeover of Auspex Pharma, last summer. PureTech initiated a phase 1 trial in healthy volunteers in March to gather data to inform studies in patients with fibrotic and inflammatory disorders. The coronavirus crisis has pushed COVID-19 to the top of PureTech’s list of targeted disorders.
PureTech plans to start a clinical trial in non-critical COVID-19 patients with respiratory complications in the third quarter. The 150 participants will receive LYT-100 or placebo for up to three months and be assessed against a primary endpoint measuring lung function. Data are due next summer.
The emerging nature of the unmet need PureTech hopes to address creates some challenges. For example, while one study found 47% of discharged COVID-19 patients had impaired gas transfer, the prevalence of post-COVID-19 fibrosis is unknown. The rate at which subjects in the placebo arm develop post-COVID-19 complications will affect whether the trial can show LYT-100 to be efficacious.