Precision BioSciences: iECURE’s gets MHRA approval for CTA app to expand study

Precision BioSciences announced that its partner iECURE has received approval from the U.K. Medicines & Healthcare products Regulatory Agency, or MHRA, for the company’s Clinical Trial Authorization, CTA, application to expand the Phase 1/2 OTC-HOPE study evaluating ECUR-506 into the U.K…The CTA approval by the MHRA follows the previous approval to begin the OTC-HOPE study by the Australian Therapeutic Goods Administration TGA …”Congratulations to iECURE for bringing the first gene editing approach into clinical investigation for patients with OTC deficiency. Approval from the MHRA to expand iECURE’s OTC-HOPE Phase 1/2 study represents yet another milestone,…To that end, we view progression through multiple regulatory agencies around the world as important proof-points for ARCUS that reflects our broader strategy to leverage ARCUS with select development partners as we continue to advance our wholly owned hepatitis B program toward an investigational new drug IND application and/or CTA filing in 2024.”