Astria Therapeutics (ATXS) Jefferies 2024 Global Healthcare Conference summary

Strategic focus and pipeline overview

• Focused on developing first-choice therapeutics for allergic and immunological diseases, aiming for best-in-class efficacy, low treatment burden, and strong safety profiles.

• STAR-0215 targets hereditary angioedema (HAE) via plasma kallikrein inhibition; STAR-0310 targets T-cell-mediated diseases like atopic dermatitis via OX40 antagonism.

• Both programs leverage clinically validated mechanisms with potential for best-in-class differentiation.

STAR-0215 clinical progress and competitive positioning

• Positive proof-of-concept data for STAR-0215 in HAE, advancing to phase III; 90%-96% reduction in mean monthly attacks and up to two-thirds of patients attack-free.

• Favorable safety profile with no injection site pain, contrasting with Takhzyro, which requires more frequent dosing and has higher rates of injection pain.

• STAR-0215 can be dosed every 3 or 6 months, compared to Takhzyro's biweekly regimen.

• HAE market for preventative therapies was over $2B in 2023, expected to exceed $4B by 2028; STAR-0215 aims for market leadership.

Upcoming milestones and regulatory plans

• Full ALPHA-STAR phase 1b/2 data for 16 patients to be released in the second half of 2024, including efficacy, safety, PK, and PD up to 6 months post-dose.

• Pivotal phase III trial for STAR-0215 to start in Q1 2025 (potentially earlier), with top-line data expected by end of 2026.

• Enrollment strategy prioritizes Q3-month dosing trial before Q6-month trial to avoid internal competition.

• Exploring U.S. commercialization independently, with potential ex-U.S. partnerships under consideration.