Nasus Pharma announced that topline data from its Phase 2 trial of NS002 intranasal dry powder epinephrine versus EpiPen intramuscular epinephrine “demonstrated multiple significant advantages for NS002 across key pharmacokinetic and pharmacodynamic parameters.” The company had announced interim data from the study earlier this year. Nasus says that it expects to initiate a pivotal trial of NS002 by the end of the year.
According to Nasus, the medium time to the 100 pg/mL plasma epinephrine threshold for NS002 was 1.69 minutes compared 3.42 minutes for EpiPen. At 2.5 minutes, approximately 67% of participants who received NS002 reached 100 pg/ml plasma concentration compared to approximately 27% for those who received EpiPen injection. At 5 minutes, 88% of participants who received NS002 reached the 100 pg/ml threshold compared to 65% of participants who received EpiPen. The company also said that NS002 demonstrated a comparable Cmax to EpiPen, “with repeat dosing showing particularly strong performance.”
Nasus Pharma CEO Dan Teleman commented, “We’ve successfully demonstrated NS002’s differentiated and potentially superior product profile compared to traditional epinephrine autoinjectors. NS002 was specifically engineered for superior epinephrine delivery, powered by our proprietary Nasax powder platform, and designed as a needle-free, easy to use and carry device. The compelling top line data significantly strengthens our conviction that NS002 has the potential to become a leading product in anaphylaxis treatment. These positive results represent a major milestone for Nasus Pharma as we advance NS002 towards the pivotal study and future marketing applications.”
Read the Nasus Pharma press release
