The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ AURA belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
The company has planned Phase 1 clinical trial with belzupacap sarotalocan in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation.
Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs, commented : "We are pleased that belzupacap sarotalocan has been granted Fast Track designation. We believe that, given that NMIBC presents such a high unmet medical need, the opportunity for more frequent interactions with Division of Oncology at FDA and the potential for Priority Review will be valuable as we advance further into clinical development in patients with NMIBC.”
Aura expects to commence the trial in the second half of 2022, and initial Phase 1 data readout is expected in the year 2023.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Aura Biosciences shares are trading high 11 percent at $14 On Thursday during pre-market session.
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