Astria Therapeutics reported that its 29‑patient ALPHA‑STAR Phase 1b/2 study of navenibart achieved dramatic reductions in hereditary angioedema (HAE) attack rates, with mean/median decreases of 84 %/93 % in Cohort 1, 90 %/100 % in Cohort 2, and 92 %/100 % in Cohort 3 over a six‑month period. Attack‑free rates reached 62 % in Cohort 2 and 67 % in Cohort 3, while quality‑of‑life scores fell by –25.37, –31.79, and –21.03 points respectively. No serious treatment‑emergent adverse events, discontinuations, or injection‑site pain were reported, and only four mild events (dizziness, transient injection‑site reaction, erythema, pruritus) were noted. The data support both quarterly (Q3M) and semi‑annual (Q6M) dosing regimens, and all 29 patients elected to enroll in the open‑label ALPHA‑SOLAR extension, with the first patient now in the ORBIT‑EXPANSE program.
These results de‑risk navenibart’s clinical development by demonstrating sustained, high‑level efficacy and a favorable safety profile in a rare‑disease population that traditionally requires frequent dosing. The ability to maintain attack‑free status and improve patient‑reported outcomes with infrequent injections positions navenibart as a potentially best‑in‑class preventive therapy, addressing a key unmet need for HAE patients and differentiating Astria from competitors that rely on daily or bi‑weekly regimens.
Chief Medical Officer Dr. Christopher Morabito emphasized the significance of the full‑enrollment data: “The updated results from the complete 29‑patient cohort are highly encouraging and reinforce our confidence in navenibart’s profile as a life‑changing preventive treatment for HAE. The rapid onset, durable efficacy, and favorable safety and tolerability profile, coupled with meaningful quality‑of‑life improvements, underscore the therapeutic potential of this novel approach.”
The positive Phase 1b/2 data clear the path to the Phase 3 ALPHA‑ORBIT program, with topline results expected in early 2027. Astria’s strong cash position and runway through mid‑2027 provide the financial foundation to support the accelerated development schedule. In a competitive landscape where other companies are pursuing more frequent dosing schedules, navenibart’s infrequent regimen offers a distinct commercial advantage that could translate into higher patient adherence and market share.
Investor sentiment has been buoyant, reflected in a 189 % share price increase over the past six months, driven by the robust clinical data and the company’s clear trajectory toward regulatory approval. The market’s positive reaction underscores the perceived value of a safe, effective, and convenient HAE therapy that could capture a significant share of the $1.5 billion global HAE market.
Astria will continue to monitor long‑term safety and efficacy in the ALPHA‑SOLAR extension while preparing for the Phase 3 trial. The company’s leadership remains optimistic that the data will support a strong regulatory submission and eventual commercialization, positioning navenibart as a cornerstone of Astria’s therapeutic portfolio.
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