Altasciences Supports 4B Healthcare’s RhineX Nasal Rinse Program Toward Phase I Clinical Testing
Altasciences has announced that its recent drug product development and manufacturing work for 4B Healthcare Inc. has helped advance the company’s investigational RhineX nasal irrigation therapy into clinical development. The collaboration brought together formulation development, research and development (R&D) manufacturing, analytical support, stability testing, packaging evaluation, chemistry, manufacturing and controls (CMC) consulting, and quality assurance activities at Altasciences’ CDMO facility in Harleysville, Pennsylvania.
Following several months of development and manufacturing work, 4B Healthcare, a Tennessee-based pharmaceutical company, received clearance from the U.S. Food and Drug Administration (FDA) to move RhineX into clinical testing under an Investigational New Drug (IND) application. The company plans to begin dosing the first participant in October 2026, marking an important transition for the program from pharmaceutical development into human clinical investigation.
The development timeline also highlights the role of integrated CDMO and contract research organization (CRO) capabilities for emerging pharmaceutical companies advancing new therapies toward the clinic. According to the companies, formulation development for RhineX began approximately seven months before the planned first subject dosing.
RhineX Targets Nasal Delivery for Allergic Rhinitis and Chronic Sinusitis
RhineX is being developed as a medicated nasal rinse platform intended to deliver medication throughout the nasal cavity. The platform incorporates 4B Healthcare’s proprietary sachet technology and is supported by both issued and pending patents, according to the company.
The therapeutic approach is being investigated for conditions including allergic rhinitis and chronic sinusitis. These conditions affect the upper respiratory tract and can produce symptoms such as nasal congestion, inflammation and irritation. Nasal irrigation is already used in ENT and allergy care, including approaches involving steroid medications, but 4B is developing RhineX as a pharmaceutical product designed specifically around medicated nasal irrigation.
The company’s development strategy builds on the established use of steroid rinses in ear, nose and throat (ENT) and allergy practices while seeking to provide a standardized pharmaceutical formulation and delivery approach.
For 4B, the program originated from clinical experience with patients who continue to experience symptoms despite conventional medical treatment.
“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 Healthcare.
Mangus said 4B was established to translate physician experience into a pharmaceutical development program and described reaching the Phase I stage as a significant milestone for RhineX. He also credited Altasciences with supporting the company through formulation development, manufacturing, regulatory preparation and the transition toward clinical testing.
Formulation Development Was Central to the Program
A major component of the collaboration involved the development and optimization of steroid formulations intended for delivery through 4B’s patented nasal irrigation sachet.
Altasciences worked on both low- and high-dose formulations as part of the development program. The company evaluated multiple prototype formulations using different formulation approaches and development techniques to identify a candidate suitable for progression toward clinical investigation.
Once prototype formulations had been assessed, Altasciences manufactured R&D batches and packaged the resulting drug product into 4B’s proprietary sachets. This allowed the formulation and packaging configuration to be evaluated together rather than treating drug product development and delivery packaging as separate stages.
For an investigational nasal rinse, formulation and packaging can be important components of development because the final product needs to be suitable for its intended administration method. The development process therefore included evaluation of the formulation as well as the packaging system used to deliver it.
The work was designed to provide 4B with a formulation that could move into the next stage of pharmaceutical development and clinical testing.
Analytical and Stability Work Supports Clinical Readiness
Beyond formulation development and manufacturing, the Altasciences program included analytical method development and qualification. Analytical methods are important in pharmaceutical development because they provide standardized approaches for assessing the identity, quality and characteristics of a drug product.
The collaboration also incorporated accelerated stability testing. Stability studies help development teams understand how a pharmaceutical product behaves under defined environmental conditions and provide information that can support decisions regarding specifications, packaging and storage.
Packaging evaluation was another component of the program, with Altasciences assessing the product configuration alongside the proprietary sachet system.
In addition, the companies worked together on CMC activities, including support for specification setting. CMC development encompasses the processes and controls used to establish how a drug substance and drug product are manufactured, tested and maintained at an appropriate level of quality.
The program also included current Good Manufacturing Practice (cGMP) and quality assurance support. These activities are particularly important as an investigational product progresses from laboratory and R&D development into clinical use.
By combining these activities within one development program, Altasciences supported the transition of RhineX from formulation experimentation toward a clinical-stage drug product.
Integrated Development Model Supports Emerging Pharmaceutical Companies
For smaller and emerging pharmaceutical companies, moving an investigational therapy into human testing can require coordination across numerous technical and regulatory disciplines. Formulation scientists, manufacturing teams, analytical laboratories, quality professionals, regulatory specialists and clinical research organizations may all contribute to the process.
Altasciences’ work with 4B illustrates an integrated model in which several of these functions are coordinated across the development pathway.
“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.
Sabelli said an integrated development model can provide continuity as a program moves from formulation and manufacturing into clinical and bioanalytical execution. He added that Altasciences expects to continue supporting 4B as RhineX advances.
The collaboration now extends beyond the Harleysville development and manufacturing facility, with clinical and bioanalytical activities planned at other Altasciences locations.
Phase I Study Planned in Los Angeles
The first Phase I clinical study of RhineX is scheduled to take place at Altasciences’ clinical site in Los Angeles, California. First subject dosing is planned for October 2026.
The clinical program will also receive bioanalytical support from Altasciences’ laboratory in Greater Montréal, Quebec. Additional CRO services will support the broader clinical development program.
The movement into Phase I testing represents a transition from product development activities into evaluation in human participants. As with other investigational therapies, the early-stage clinical program is expected to provide information that can guide subsequent development of RhineX.
The companies have not indicated that Phase I testing will establish the therapeutic’s effectiveness for allergic rhinitis or chronic sinusitis. Instead, the study represents the next development stage following the formulation, manufacturing, analytical, stability and regulatory work completed to date.
Building a Path Toward Further Clinical Development
The FDA clearance to begin clinical testing represents a milestone for 4B Healthcare as it advances RhineX from development into human studies. The company’s approach centers on a medicated nasal irrigation platform intended to provide medication delivery across the nasal cavity through a proprietary sachet.
For Altasciences, the RhineX program demonstrates the potential role of integrated CDMO and CRO services in supporting pharmaceutical programs through multiple development stages. Work at the Harleysville facility addressed formulation and R&D manufacturing, while analytical, stability, packaging, CMC and quality activities helped prepare the selected formulation for clinical development.
The planned Phase I study will add another component to the collaboration through Altasciences’ Los Angeles clinical site, with bioanalytical testing provided by the Greater Montréal laboratory.
For 4B Healthcare, the upcoming clinical study will provide the first opportunity to evaluate RhineX in human participants following its preclinical and pharmaceutical development work. The company is pursuing the program for allergic rhinitis and chronic sinusitis, conditions in which nasal inflammation and related symptoms can create an ongoing treatment challenge.
The October 2026 first dosing milestone therefore marks the beginning of a new phase for RhineX. While additional clinical studies will be required to determine the therapy’s safety, tolerability and potential therapeutic role, the FDA clearance allows 4B to move its investigational nasal rinse into formal clinical development.
The companies’ collaboration also underscores how formulation science, manufacturing capabilities, analytical development, quality systems and clinical research can be connected within a single development pathway. With the Phase I program approaching, Altasciences and 4B are continuing their work to advance RhineX through clinical investigation and determine its potential as a pharmaceutical approach for patients with allergic rhinitis and chronic sinusitis.
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.