- Altasciences has supported formulation development, R&D manufacturing, stability testing and quality assurance for 4B Healthcare’s RhineX nasal irrigation therapy, which has received FDA clearance to proceed to clinical testing under an IND.
- First subject dosing is planned for October 2026, with the Phase I study to be conducted at Altasciences’ Los Angeles site and additional bioanalytical support from its Greater Montréal laboratory.
Altasciences has supported the development of 4B Healthcare’s RhineX nasal irrigation therapy, helping the program advance to clinical investigation after FDA clearance to proceed with testing under an Investigational New Drug (IND) application. First subject dosing is planned for October 2026, approximately seven months after formulation development began.
The work was conducted at Altasciences’ CDMO facility in Harleysville, Pennsylvania, and included formulation development, R&D manufacturing, stability testing and quality assurance support. The companies developed and evaluated multiple low- and high-dose steroid formulations for a 4B-patented sachet designed for nasal irrigation. Altasciences also manufactured R&D batches and packaged them into 4B’s proprietary sachets for testing.
RhineX is described as a medicated nasal rinse platform designed to deliver medication throughout the nasal cavity. 4B is developing the therapy for patients with allergic rhinitis and chronic sinusitis, building on the use of steroid rinses in ENT and allergy practice. The development program also included analytical method development and qualification, accelerated stability testing, packaging evaluation and CMC consulting, including specification-setting support.
The Phase I clinical study will be conducted at Altasciences’ site in Los Angeles, California, with bioanalytical support from the company’s laboratory in Greater Montréal, Quebec. Altasciences will also provide broader CRO services for the program.
“We’re proud to see the work completed by our Harleysville team help move RhineX into the clinic. 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.”
Robert Sabelli, President, Drug Development Solutions at Altasciences
