Arch Biopartners Has Pre-IND Meeting With FDA to Discuss Repurposing Cilastatin as a New Treatment to Prevent Acute Kidney Injury

TORONTO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it had a pre-investigational new drug application (PIND) meeting with the U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products (DCRP) on February 23, 2024 to discuss Arch’s plan to repurpose cilastatin as a new treatment to prevent toxin related acute kidney injury (AKI). Currently, there are no specific treatments for the prevention or treatment of AKI.

Arch has the opportunity to sponsor a Phase II trial for cilastatin in toxin-related AKI targeting either nephrotoxic drug and/or rhabdomyolysis-associated AKI (explained further below).

The PIND meeting provided the Arch team with guidance from the FDA for the content of a future IND application for cilastatin. An IND application is a request to the FDA for authorization to administer a new drug to patients in a human trial. The Arch team received clarity on several items including cilastatin pharmacology; manufacturing of a cilastatin drug product; design of phase II study protocol targeting toxin-related AKI; and the regulatory path that would lead to a New Drug Application (NDA).

Arch is acting as an industry partner with clinical researchers in Canada and the United States who are planning to conduct two separate phase II clinical studies respectively for toxin-related AKI in late 2024. Arch management does not have plans to raise funds during 2024 in the capital markets for cilastatin trials. The Company will support these studies by acting as a partner for grant funding opportunities, providing cilastatin drug product, scientific advice, and pursuing regulatory approvals.

Arch management is overseeing the development and manufacturing of a first-ever, stand-alone cilastatin drug product. Arch has arranged for the production of the first lot of a cilastatin to occur during the summer of 2024.

Arch has method of use patents in several jurisdictions for repurposing cilastatin as a treatment for AKI. The patents are either proprietary or exclusively licensed to Arch.

Quote from Richard Muruve, CEO of Arch Biopartners Inc:

“The PIND meeting was the first major milestone in the effort to commercialize cilastatin, Arch’s second drug targeting DPEP-1. Third-party research and clinical interest to test cilastatin as a first ever treatment for both rhabdomyolysis-associated AKI and drug toxin-related AKI have provided the catalyst for Arch to advance this technology toward an NDA in parallel with the LSALT peptide program. We look forward to working with our research and clinical collaborators to establish cilastatin and DPEP-1 inhibition as a new treatment to prevent toxin-related AKI.”