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Mar 31, 2023
Inozyme Q1 2023 Earnings Report
Reported financial results for the first quarter ended March 31, 2023, and provided business highlights.
Key Takeaways
Inozyme Pharma reported its Q1 2023 financial results, highlighting the advancement of INZ-701 and the anticipation of initiating a pivotal trial for pediatric patients with ENPP1 Deficiency in Q3 2023, pending regulatory approval. The company's cash, cash equivalents, and short-term investments are expected to fund cash flow requirements into the fourth quarter of 2024.
Reached agreement with the European Medicines Agency (EMA) on a Pediatric Investigational Plan (PIP) for the study of INZ-701 in pediatric patients with ENPP1 Deficiency.
Dosed the first adult patient with ENPP1 Deficiency in an additional dose cohort designed to investigate the potential for once-weekly dosing of INZ-701 in the ongoing trial.
Announced the first self-administration of INZ-701 in the open-label Phase 2 portion of the ongoing clinical trial in adults with ABCC6 Deficiency (pseudoxanthoma elasticum or PXE).
Yves Sabbagh, Ph.D., presented topline data from the ongoing Phase 1/2 clinical trial of INZ-701 in patients with ENPP1 Deficiency at the European Calcified Tissue Society (ECTS) on April 17, 2023.
Inozyme
Inozyme
Forward Guidance
Inozyme Pharma anticipates several milestones in the near term. Initiation of ENERGY-1 – Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of INZ-701 in infants – Q2 2023. Initiate scientific advice process with EMA regarding our comprehensive development plan covering all age groups– Q2 2023. Interim data from the Phase 2 portion of the ongoing trial in adults – Q3 2023. Initiation of pivotal trial in pediatric patients, subject to regulatory approval – Q3 2023. Interim data from the Phase 2 portion of the ongoing trial in adults – Q4 2023
Positive Outlook
- Initiation of ENERGY-1 – Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of INZ-701 in infants – Q2 2023
- Initiate scientific advice process with EMA regarding our comprehensive development plan covering all age groups– Q2 2023
- Interim data from the Phase 2 portion of the ongoing trial in adults – Q3 2023
- Initiation of pivotal trial in pediatric patients, subject to regulatory approval – Q3 2023
- Interim data from the Phase 2 portion of the ongoing trial in adults – Q4 2023