Nasus Pharma Ltd, a clinical-stage pharmaceutical company focused on innovative intranasal products for emergency medical conditions, has initiated its Phase 2 clinical study for NS002, its investigational intranasal epinephrine powder formulation. The company announced the dosing of the first participant in Canada, marking a critical step in the development of another needle-free nasal spray alternative to traditional epinephrine auto-injectors for the emergency treatment of anaphylaxis.
The successful initiation of this trial reflects the culmination of preclinical work and a previous clinical study, which demonstrated that NS002 can achieve faster and higher absorption of epinephrine compared to an auto-injector. Discussing the importance of the program, Dan Teleman, CEO of Nasus Pharma, stated:
The dosing of the first participant in our Phase 2 study marks a significant milestone for our NS002 program and for patients with severe allergies who need more user-friendly treatment options to manage life-threatening anaphylaxis.
The need for simpler administration methods remains high, as issues related to current injection-based devices often lead to suboptimal patient care. Teleman elaborated on this unmet need, noting the compliance challenge associated with current delivery systems: “For millions suffering from severe allergies, the fear of needles and the inconvenience of carrying cumbersome autoinjectors leads to poor compliance and potentially life-threatening outcomes in anaphylaxis management.” NS002 is being developed to overcome these barriers, offering a non-invasive, pocket-friendly solution.
The Phase 2 study is an open-label, fixed-sequence trial designed to robustly evaluate the drug candidate. The primary objective is to evaluate the pharmacokinetic parameters (how the drug is absorbed and processed by the body) and hemodynamic responses (effects on blood circulation) of NS002. The trial will compare NS002 with the established market leader, EpiPen, in a cohort of 50 healthy adult participants with a history of allergic rhinitis.
The rapid, reliable delivery of NS002 is enabled by Nasus’s proprietary Powder-Based Intranasal (PBI) technology. This innovative platform is designed to leverage the nasal cavity’s rich vascular network for quick absorption into the bloodstream. The PBI formulation utilizes uniform spherical powder particles to ensure broad dispersion and potentially faster, higher absorption rates compared to liquid-based nasal sprays, which could be vital when treating acute, time-sensitive conditions like anaphylaxis.
With the clinical program now fully underway, Nasus Pharma is focused on advancing the product as quickly as possible. The CEO confirmed the development pipeline is “moving forward at full speed, executing the NS002 development program as planned, and positioning the Company for its next stage of growth.” The company anticipates reporting key interim results from this pivotal Phase 2 trial in the first quarter of 2026, offering a clear timeline for the advancement of this promising needle-free treatment option.
