Three years on from a splashy unveiling, Areteia Therapeutics has reported a phase 3 victory that could boost its bid to launch an oral rival to the biologics that dominate a multibillion-dollar asthma market.
Knopp Biosciences created Areteia with private equity firm Population Health Partners after reporting phase 2 data on the small molecule dexpramipexole in eosinophilic asthma. The results persuaded an investor syndicate, led by Bain Capital Life Sciences, to put together a $350 million series A. Areteia later tapped additional investors to swell the total size of the round to $425 million.
Tuesday, the biotech provided the first evidence that the big bet may pay off by reporting that Exhale-4 has hit its primary endpoint. The trial compared dexpramipexole to placebo in 600 people with inadequately controlled moderate-to-severe eosinophilic asthma.
Exhale-4's primary endpoint looked at the average lung function of study participants between Weeks 20 and 24. Lung function was significantly better in people who took the high dose of dexpramipexole twice a day than in patients who received placebo, achieving the primary endpoint. Areteia said it saw significant improvements in lung function from Week 4 onward.
The company's press release lacks information on how the low dose performed on the primary endpoint.
Both doses significantly reduced average blood absolute eosinophil counts among treated patients between Weeks 20 and 24, the biotech said. Eosinophils are white blood cells that drive symptoms in more than half of people with asthma.
People with eosinophilic asthma have multiple treatment options. AstraZeneca’s Fasenra, GSK’s Nucala and Teva’s Cinqair, all of which are anti-IL-5 antibodies, are authorized in the indication. Sanofi and Regeneron’s Dupixent, which inhibits the signaling of IL-4 and IL-13, is also approved in the setting. All of the products are injectable biologics.
Areteia and its backers are betting there is a market for a small molecule that lowers eosinophils, like IL-5 drugs, but is given orally.
Exhale-4 is one of three phase 3 studies that the company is running to validate dexpramipexole. Areteia is continuing to enroll eosinophilic asthma patients in two phase 3 exacerbation studies of dexpramipexole.