- Auris Medical Holding Ltd (NASDAQ: EARS) has announced additional information regarding the results from the clinical trial of its nasal spray, Bentrio, meant for treating people suffering from allergic rhinitis.
- Additionally, the company also provided an essential update about the regulatory path for the product in the U.S.
- Bentrio managed to hit the primary endpoint about the clinical evaluation into allergic rhinitis.
- More importantly, the reduction in nasal symptoms was not only significant but also clinically relevant.
- On the other hand, the product was also given high efficacy rating by clinicians and patients. In the pre-submission meeting with the FDA, it emerged that the agency supports a 510(k) regulatory path.
- Bentrio effectively alleviates allergy symptoms in clinical pollen challenges.
- It was tested in an open-label randomized cross-over trial in 36 patients with allergic rhinitis to grass pollen.
- Participants under Bentrio treatment reported a mean increase in the Total Nasal Symptom Score (TNSS) of 4.75 points, which was 1.11 points and thus significantly below nasal score levels when exposed to pollen without nasal spray protection.
- A 1-point reduction in the TNSS is considered clinically relevant. 31.4% of study participants rated the efficacy of Bentrio as “good” or “very good,” while study investigators provided such rating for 45.7% of participants.
- Under treatment with the comparator product, a powder spray based on hydroxypropylmethylcellulose (HMPC), the TNSS increased on average by 5.14 points, which was 0.71 points lower than when unprotected.
- 14.3% of study participants rated the efficacy of the comparator as “good” or “very good,” while study investigators provided such rating for 25.0% of participants.
- Price Action: EARS shares are up 15% at $3.30 during the market trading session on the last check Friday.
Auris Medical Stock Is Trading Higher As Bentrio Hit Primary Endpoint Goal In Allergic Rhinitis Study