BOSTON - Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company with a market capitalization of $420 million, announced the design of its ALPHA-ORBIT Phase 3 clinical trial for navenibart, a treatment for hereditary angioedema (HAE). The company's stock, currently trading near its 52-week low of $6.91, appears undervalued according to InvestingPro analysis. The trial, expected to commence this quarter, will investigate the efficacy and safety of navenibart with dosing every three and six months over a six-month period.
The ALPHA-ORBIT trial is a randomized, double-blind, placebo-controlled study designed to enroll up to 145 patients with Type 1 or Type 2 HAE. Participants will be assigned to one of three navenibart dose arms or a placebo group. The primary endpoint will measure time-normalized monthly HAE attacks at six months, with a key secondary endpoint assessing the proportion of attack-free participants at the same interval. Successful completion of the six-month study will allow patients to enter a long-term extension trial with open-label navenibart administration.
The decision to initiate the ALPHA-ORBIT trial follows positive results from the Phase 1b/2 ALPHA-STAR trial, which reported a 90-95% reduction in mean monthly attack rate and up to a 67% attack-free rate over six months. The Phase 3 program, including the ALPHA-ORBIT trial and the extension trial, aims to support global registration for the drug.
Astria's CEO, Dr. Jill C. Milne, expressed confidence in navenibart's potential as a market-leading therapy for HAE, emphasizing the importance of patient-centric dosing flexibility. Dr. Christopher Morabito, Chief Medical (TASE:PMCN) Officer at Astria, highlighted the collaborative design of the trial, incorporating feedback from patients, physicians, and global regulatory authorities.
Navenibart is a monoclonal antibody inhibitor of plasma kallikrein, a protein involved in swelling attacks associated with HAE. Astria aims to provide patients with a treatment option that offers rapid and sustained attack prevention. The company's financial position is reported to be strong, with sufficient funding to carry through the expected top-line Phase 3 results. InvestingPro data reveals a healthy current ratio of 22.38, indicating robust short-term liquidity, with more cash than debt on its balance sheet. While the company is currently unprofitable, analysts maintain a strongly bullish outlook with price targets ranging from $16 to $35. (Discover 10+ additional financial insights and ProTips with an InvestingPro subscription.)
Astria Therapeutics is dedicated to developing therapies for allergic and immunologic diseases. The company's mission is to bring life-changing treatments to patients and families affected by these conditions. Despite recent market volatility, with the stock down about 12% in the past week, the company maintains a relatively low beta of 0.7, indicating lower volatility compared to the broader market. Further details about the company's Phase 3 program for navenibart and other business updates are available in the corporate presentation on the company's website and through comprehensive financial analysis on InvestingPro.
This article is based on a press release statement from Astria Therapeutics, Inc.
In other recent news, Astria Therapeutics has made significant strides in the biotech sector. The company announced an amendment to its 2022 Inducement Stock Incentive Plan, increasing the number of shares reserved for issuance from 1.7 million to 2.8 million. This move is intended to attract and retain top talent with competitive compensation packages. In addition, the FDA has cleared Astria's new AD drug for trial, with the initiation of the Phase 1a trial and a subsequent proof-of-concept study in AD patients expected in 2026.
Astria's investigational therapy, navenibart, has received Orphan Medicinal Product Designation from the European Commission and Orphan Drug Designation from the FDA for the treatment of hereditary angioedema (HAE). The company plans to advance navenibart into a Phase 3 trial in 2025. Astria has also partnered with Ypsomed AG for the development of an autoinjector for navenibart, aiming to provide patients with a user-friendly administration method.
Analyst firms TD Cowen and H.C. Wainwright have maintained their Buy ratings for Astria, emphasizing the potential of navenibart, while Oppenheimer has raised its stock target for the company, maintaining an Outperform rating, despite a higher than expected second-quarter loss. These are the recent developments in Astria Therapeutics' journey.
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