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Arch Biopartners Completes Pre-IND Meeting with U.S. FDA on LSALT Peptide for Preventing Acute Kidney Injury in Cardiac Surgery Patients
May. 08, 2018 09:47AM PST
Biotech Investing
Arch Biopartners (TSX Venture:ARCH) (OTCBB:ACHFF), announced today it completed a successful pre-IND (Investigational New Drug) meeting via teleconference on April 18 with members of U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products and the Office of Clinical Pharmacology. As quoted in the press release: The FDA members addressed questions from the …
Arch Biopartners (TSX Venture:ARCH) (OTCBB:ACHFF), announced today it completed a successful pre-IND (Investigational New Drug) meeting via teleconference on April 18 with members of U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products and the Office of Clinical Pharmacology.
As quoted in the press release:
The FDA members addressed questions from the Arch team and discussed key components of the planned IND application for Metablok (“LSALT peptide”), Arch’s novel drug candidate to prevent acute kidney injury during cardiac surgery.
Currently, there are no specific treatments for the prevention of acute kidney injury.
“During the Pre-IND meeting the FDA provided us confirmation on the pre-clinical data and content of our upcoming IND application. Over the next few months we will complete our original toxicology plan, finalize our IND application and continue to prepare for the phase I human trial for the LSALT peptide,” said Dr. Daniel Muruve, Chief Science Officer of Arch.