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July 1, 2021

LoA Update: Nasus’ intranasal epinephrine for seasonal allergic rhinitis chance to progress to next development stage jumps by 15 points with Phase I data announcement

Nasus Pharma’s intranasal epinephrine FMXIN002 for seasonal allergic rhinitis had its Phase Transition Success Rate (PTSR) increase by 15 points to 77% after positive Phase I results were reported.

By Reynald Castañeda

Nasus Pharma’s intranasal epinephrine FMXIN002 for seasonal allergic rhinitis had its Phase Transition Success Rate (PTSR) increase by 15 points to 77% after positive Phase I results were reported. Trial results were revealed on 25 June, with the PTSR adjustment made on 25 June. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

Intranasal spray FMXIN002 features a powder formulation of epinephrine, designed to rescue users from severe allergic reactions to food, medications, and insect bites. Phase I (NCT04696822) recruited 12 volunteers with known seasonal allergies, with primary endpoints investigating FMXIN002’s pharmacokinetic profile with or without allergic challenge. Results show exposure and maximum plasma levels of 3.2mg FMXIN002 was comparable to a 0.3mg epinephrine injection. Although, time to maximum plasma levels with FMXIN002 was faster than the epinephrine injection. A lower 1.6mg FMXIN002 dose was also investigated.

Tel Aviv, Israel-based Nasus’ FMXIN002 Likelihood of Approval (LoA) increased by one point to 8% with Phase I data. LoA is calculated by GlobalData’s analysis, uses a combination of machine learning and a proprietary algorithm.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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