Morria Biopharmaceuticals has obtained regulatory approval from the South African Medicines Control Council to initiate a Phase II study of MRX-4 in 105 patients suffering from allergic rhinitis.
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The two-arm, randomized, multi-dose, double-blind, placebo-controlled study includes a steroid comparator arm. The study will evaluate the safety, tolerability, and preliminary efficacy of intranasal MRX-4 in allergic rhinitis (AR) patients outside of allergy season as compared with both placebo and an intranasal steroid.
An experimental multi-functional anti-inflammatory drug, MRX-4 is a non-steroidal potential treatment for AR that was shown to be safe and well tolerated in a Phase I equivalent trial completed in Israel earlier this year.
Yuval Cohen, president of Morria, said: “This study will provide valuable data regarding its potential in allergic rhinitis, including efficacy, tolerability and pharmacokinetic data.”
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