Updates are available Correction dated 2025-03-07

Article History

Accepted: 12 January 2025

First Online: 29 January 2025

Change Date: 7 March 2025

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40261-025-01431-0

Declarations

:

: Pharmacokinetic analysis and data consolidation were provided by Xyzagen, Inc and funded by Cali Biosciences. Medical writing support was provided by Michelle M. Merrigan of Merrigan Medical Writing, LLC, and funded by Cali Biosciences.

: The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed in the funding statement.

: The three clinical studies sponsored by Cali Biosciences were designed and conducted in accordance with US and international standards of Good Clinical Practice (GCP) (Food and Drug Administration (FDA) regulation 21 CFR 312 for IND studies and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH] Guideline E6). All participants provided written informed consent. All protocols and informed consent forms were reviewed and approved by the Advarra institutional review board (IRB) prior to study initiation. The Advarra ID numbers for the CPL-01 studies were: Pro00039793 for CPL-01_AB_001, Pro00055229 for CPL-01-201, and Pro00063126 for CPL-01-202. Published studies used in the comparative analysis were approved by an independent ethics committee or IRB and conducted in accordance with the ethical principles of the Declaration of Helsinki, in compliance with GCP and applicable regulatory requirements.

: All participants who participated in the three clinical studies provided written informed consent for their anonymised data to be published.

: The data from the CPL-01 clinical trials will be available in Clinical Trials, following an embargo from the date of publication to allow for commercialization of research findings.

: Not applicable for this work.

: S.P., C.C, and S.T. were responsible for the acquisition, analysis, and interpretation of data; S.P., C.C., S.T., H.X., P.J.C., L.C., D.D.H., and E.O. were responsible for reviewing the data and drafting and revision of the manuscript. All authors have read and approved the final submitted manuscript and agree to be accountable for the work.

: All participants who participated in the three clinical studies provided written informed consent for their anonymised data to be published.