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news.Amira Pharmaceuticals has filed an Investigational New Drug (IND) application for its new LPA1 antagonist, AM152 to the US Food and Drug Administration (FDA).
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The company said that if its AM152 IND got accepted by the FDA, it will be eligible to commence Phase 1 safety studies with the compound in healthy subjects.
Amira Pharma vice president Clinical Development Isabelle DeArmond said that they believe the pre-clinical data obtained to date for AM152 demonstrate characteristics which warrant further studies in humans to determine its potential utility in various fibrotic diseases.
“The safety and pharmacokinetic data obtained from Phase 1 studies are an important first step in the clinical investigation of this program,” DeArmond said.
Amira Pharma CEO Bob Baltera said that they have worked hard to develop this program and look forward to learning more about this potential therapeutic candidate in a clinical setting.”