Altasciences is proud to announce that recent formulation work supporting 4B Healthcare Inc. (“4B”) has helped advance its RhineX nasal irrigation rinse therapy into clinical investigation. Following several months of formulation development, R&D manufacturing, stability testing, and quality assurance support at Altasciences’ CDMO facility in Harleysville, PA, the Tennessee-based pharmaceutical company has received FDA clearance to proceed with clinical testing of RhineX under its IND. First subject dosing is planned for October 2026, approximately seven months after formulation development began.

"The concept for RhineX grew out of a problem I have seen in my own ENT practice for years—the need for a better treatment option for allergic rhinitis when conventional medical therapy is not enough,” said Brannon Mangus, MD, Co-Founder and CEO of 4B. “We founded 4B Healthcare to take that physician insight and turn it into a pharmaceutical product that could meaningfully change how these patients are treated. Altasciences has been an exceptional partner in our FDA journey.

Their ability to support us through drug product development and manufacturing, regulatory preparation, and now our Phase I clinical study has provided exactly the kind of integrated partnership an emerging pharmaceutical company needs. Reaching the Phase I clinical trial stage is an important milestone for RhineX, and Altasciences has been integral to 4B reaching this milestone.”

RhineX is a first-in-class medicated nasal rinse platform, with patents both approved and pending, designed to deliver medication throughout the nasal cavity and provide a simpler approach to steroid nasal irrigation for patients and healthcare providers. 4B is developing the therapeutic for patients with allergic rhinitis and chronic sinusitis, building on the use of steroid rinses in ENT and allergy practice.

The collaboration focused on developing and optimizing low- and high-dose steroid formulations for a 4B-patented sachet designed for nasal irrigation. Altasciences developed and evaluated multiple prototype formulations using innovative approaches and techniques, then manufactured R&D batches and packaged them into the 4B-proprietary sachets for testing.

The program also included analytical method development and qualification, accelerated stability testing, packaging evaluation, CMC consulting, including support for specification setting, and cGMP and quality assurance support to help advance the selected formulation toward clinical use.

“We’re proud to see the work completed by our Harleysville team help move RhineX into the clinic,” said Robert Sabelli, President, Drug Development Solutions at Altasciences. “This is where an integrated development model can make a real difference, allowing a program to move from formulation and manufacturing into clinical and bioanalytical execution with continuity across teams. We look forward to continuing to support 4B as RhineX advances.”

The Phase I clinical study will be conducted at Altasciences’ site in Los Angeles, CA, with bioanalytical support from its laboratory in Greater Montréal, QC, and broader CRO services supporting the program.

About Altasciences

Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, and formulation and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof-of-concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. To learn more about Altasciences, visit altasciences.com.

About 4B Healthcare Inc.

4B Healthcare Inc. (“4B”) is a pharmaceutical company focused on developing innovative therapies in otolaryngology (ENT). Founded in 2024 by ENT surgeon Brannon D. Mangus, M.D., and Matthew C. Stearns, and headquartered in the Nashville, Tennessee metropolitan area, 4B is developing a proprietary platform of first-in-class medicated nasal rinse therapies with patents both approved and pending. The company’s lead product candidate is being developed for the treatment of allergic rhinitis, a condition affecting up to 60 million people in the United States annually. 4B received its first approved U.S. patent in the third quarter of 2026 from the U.S. Patent and Trademark Office (USPTO), and it has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial of its lead product candidate, which the company expects to initiate in the fourth quarter of 2026. To learn more about 4B Healthcare, visit 4bhealthcare.com or contact media@4bhealthcare.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20260924501180/en/

Julie-Ann Cabana
Altasciences
media@altasciences.com

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