Airway Therapeutics Completes Dose Escalation in Phase 1b Trial of Zelpultide Alfa (AT-100) for Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
11.4.2023 12:30:00 EEST | Business Wire | Press release
Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, announced today it successfully finished the dose escalation portion of its Phase 1b trial of zelpultide alfa for preventive use in very preterm infants at risk for bronchopulmonary dysplasia (BPD). Airway began recruiting patients on March 28, 2023 for daily treatment up to 7 days at the highest dose of zelpultide alfa (rhSP-D) following a Data Safety Monitoring Committee (DSMC) report of no safety concerns.
The Phase 1b trial is being conducted in the U.S. and Spain. Airway has established a subsidiary, Airway Spain SL, to lead the Phase 1b trial and subsequent clinical trials across the E.U.
“This is a significant milestone in our efforts to protect these infants from suffering severe BPD. The very favorable safety profile is particularly important in these extremely vulnerable preterm neonates,” said Airway CEO and Chief Medical Officer Marc Salzberg, M.D.
“The DSMC confirmed the excellent safety profile of zelpultide alfa following completion of the third cohort of infants who received the highest dose. This dose is being used in a fourth and final cohort which now also includes infants born at 23 - 24 weeks, the earliest gestational age in our study.”
As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. Babies who develop BPD can suffer lifelong complications such as asthma and pneumonia as well as growth and developmental problems.
Zelpultide alfa is a recombinant version of the endogenous human SP-D, a protein essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. The biologic is administered intratracheally during mechanical ventilation.
The Phase 1b trial is a randomized, blinded, air-sham controlled study to establish the safety and tolerability of zelpultide alfa. Interim analysis of the data is expected in early Q2 2023. The FDA and European Medicines Agency have granted orphan drug status to zelpultide alfa.
About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing zelpultide alfa, a novel recombinant human protein hSP-D that reduces inflammation and infection in the body while modulating the immune response. Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID/CAP in seriously ill mechanically ventilated patients.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230411005273/en/
Contact information
Meghan Riley
riley@airwaytherapeutics.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Behind the Stage Lights: How Students Learned to Trust Their Voices with Doha Debates14.9.2026 16:40:00 EEST | Press release
During high school years in Model United Nations, Dahlia Al-Ansari learned to argue on behalf of a country she was assigned to represent. But when Doha Debates invited her to join a town hall debate in Toronto this July, she faced an unfamiliar challenge: sharing her own beliefs about a timely issue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914150232/en/ Students from Qatar, Canada and Mexico during their visit to the University of Toronto as part of the Doha Debates Town Hall experience in Canada. (Photo: AETOSWire) An 18-year-old biological sciences student at Carnegie Mellon University in Qatar, Al-Ansari hadn’t traveled to defend a predetermined position. Instead, she discovered that she was there to think critically, express her own viewpoint and remain open to diverse perspectives. This shift required her to navigate uncharted waters, but “I’m happy that it did,” she says. “It’s showing me the importance of sp
Matt Shafer Joins Golub Capital as Head of Golub Equity Continuation Partners14.9.2026 16:30:00 EEST | Press release
Golub Capital (“the Firm”) today announced the appointment of Matt Shafer as Managing Director and Head of the Firm’s GP-led private equity secondaries strategy, Golub Equity Continuation Partners (“GECP”). In this role, he will be responsible for leading the continued growth and development of the strategy and helping expand the Firm’s equity investment capabilities. Matt will work closely with Greg Cashman, Vice Chair and Co-Head of Golub Capital’s Sponsor Finance practice, to expand Golub Capital’s activity in this growing market. Shafer brings nearly three decades of global experience as an investor, financier and advisor working with private equity firms. He was most recently Head of Capital Solutions and U.S. Private Equity at Northleaf Capital Partners. In this role, Shafer helped lead the firm’s private equity investment activities, including secondaries, co‑investments and structured capital. Prior to Northleaf, he was Partner and Head of Americas Private Equity at Vision Capi
HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI14.9.2026 16:19:00 EEST | Press release
AMRA Medical today announced an investment from HealthCap, one of Europe’s leading life science venture capital firms. This milestone marks a significant step in AMRA’s growth, underscoring market confidence in the company’s vision to transform the measurement and understanding of muscle and fat. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914838191/en/ HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI HealthCap’s backing comes as quantitative MRI gains vital importance in understanding how fat distribution and muscle composition influence disease, treatment response, and patient outcomes. Built on over 15 years of research, AMRA’s proprietary methods move beyond conventional metrics—like weight, and BMI and muscle function tests—to provide the standardized, automated data from advanced muscle and fat imaging necessary for modern clinical research. With its deep scientific expertise and
Morgan Stanley Inclusive & Sustainable Ventures Announces 2026 Global Cohort of Innovators14.9.2026 16:00:00 EEST | Press release
Morgan Stanley (NYSE: MS) today announced the 2026 global cohort of its Inclusive & Sustainable Ventures (MSISV). This year’s cohort includes 20 startups and four nonprofits across the Americas and Europe, the Middle East and Africa (EMEA) participating in the firm's five-month accelerator program designed to help early-stage innovators develop and scale their impact. Selected from thousands of applications, the 24 organizations will receive a $150,000 equity investment, or grant funding for nonprofits, as well as access to a curated curriculum, networking opportunities and office space. Founders will work closely with a dedicated MSISV team, Entrepreneurs in Residence and senior Morgan Stanley mentors. Following the five-month accelerator program, the cohort will present at a global showcase and demo day in February 2027. MSISV is focused on advancing solutions in four thematic areas where the firm sees significant potential for scale and measurable impact: Environment, Health & Wellb
Textron Aviation and Merlin Introduce Cessna SkyCourier UX Concept Aircraft14.9.2026 15:00:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, and Merlin, Inc. today introduced a concept Cessna SkyCourier UX™ aircraft that combines Textron Aviation’s proven Cessna SkyCourier platform with Merlin’s aircraft-agnostic software solution for autonomous aviation. Revealed at the Air, Space & Cyber Conference, the concept explores a new cost-efficient and scalable approach to addressing logistical challenges with supplying forces dispersed across contested operational environments when traditional supply routes are constrained, vulnerable or otherwise unavailable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914611105/en/ The Cessna SkyCourier UX concept explores autonomous resupply operations for dispersed forces operating in contested environments “Military planners are increasingly focused on how to sustain forces across distributed and contested operational environments,” said Bob Gibbs, vice president, D
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom