Pieris Pharma Pushes Elarekibep Data Readout, Investors React Negatively
- Pieris Pharmaceuticals Inc reported Q4 earnings and provided updates across its pipeline.
- The investors are reacting to the further pushback of the timeline for the readout from the Phase 2a study of elarekibep to mid-2024 from prior guidance of the third quarter of 2023.
- Pieris is collaborating with AstraZeneca Plc to develop elarekibep for asthma patients.
- AstraZeneca has communicated that completion of the Phase 2a study remains an important priority and that additional resources have been provided to achieve study completion.
- William Blair writes that implementing protocol amendments to widen enrollment criteria and reduce site and the patient burden is beginning to have an impact.
- The protocol amendment, FEV1, has been widened to 50% to 85% of normal from 60% to 80%. The study now allows enrollment of patients on high-dose ICS LABA versus moderate dose prior, which management believes addresses about 50% of screen failures.
- The analyst writes that the delay puts the readout for the Phase 2a study right toward the end of the company’s current cash runway guidance, creating more concerns about the ability to support additional development plans.
- Pieris Pharmaceuticals ended FY22 with a cash balance of $59.2 million, providing a cash runway for the next 12 months.
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