Medical Innovation Exchange

Roivant’s inflammatory med gets back on track with phase 2 eye disease data

Roivant’s autoimmune treatment impressed in a phase 2 trial, reporting treatment failure rates among patients with non-infectious uveitis (NIU) that executives touted as the best seen in active studies. 

The company, known for turning shelved pharma assets into valued medicines, believes it has struck gold once more, with Roivant’s leadership using Tuesday’s readout to allude to brepocitinib’s blockbuster potential.

“With data like the data we’re generating, we just feel highly confident,” CEO Matt Gline told investors.  

The phase 2 trial enrolled 26 patients with the inflammatory eye condition, with 17 receiving 45 mg of brepocitinib and nine receiving a 15 mg dose. Roivant found that at week 24, 29% of patients receiving 45 mg of once-daily brepocitinib and 44% of patients receiving 15 mg reached the pre-specified criteria for treatment failure, meeting the study’s primary endpoint. Treatment failure was defined as a worsening in one of three measurements assessing either vision or eye irritation, where lower rates are indicative of greater benefits from the therapy.

When discontinuations were censored from the analysis, the treatment failure rate for the 45 mg arm was 18%. The treatment failure rates at both doses were lower than the performance of AbbVie’s blockbuster Humira in a previous phase 3 trial for NIU, the company pointed out in a presentation to investors. 

Roivant also reported that all secondary endpoints were “positive and dose-responsive” at the 24-week mark. 

“Against that backdrop, we are thrilled to see a failure rate of only 29% in the brepocitinib 45 mg arm, better than any precedent study was able to achieve even with more lenient tapers,” Ben Zimmer, CEO of Roivant’s Priovant unit, said in a release. 

Roivant said brepocitinib was well-tolerated with one treatment-emergent adverse event reported in the 15 mg dose group. No new safety signals have arisen, the company added.

Brepocitinib was snagged from Pfizer in 2022. Roivant had also been exploring the drug in lupus, but dropped that program in November after it failed to demonstrate an improvement in disease activity in a phase 2 study.

Luckily for Roivant, today’s readout means it’s full-steam ahead for brepocitinib development in NIU, including a phase 3 trial slated to get underway in the second half of 2024. Gline said it’s “relatively unlikely” that Roivant would include a Humira comparator arm in a the upcoming late-stage study but said plans will be cemented after an end-of-phase-2 meeting with the FDA. 

As for the asset’s dermatomyositis indication, a phase 3 trial is set to be fully enrolled by the third quarter. On today’s call, Zimmer loosely co-signed an investor’s back-of-the-napkin math that data could be expected in the second half of 2025. The expectation is that more indications could soon be tacked onto the development plan, with Gline telling investors: “We have a lot of ideas.” 

“Every time we read out positive data with this compound and look at it, it makes us feel like we should be doing more with it,” Gline added.  

https://www.fiercebiotech.com/biotech/roivants-inflammatory-med-gets-back-track-phase-2-eye-disease-data

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