Arch Biopartners Inc. announced it has entered into an exclusive worldwide license agreement with Telara Pharma of Spain (“Telara”) to clinically develop and market cilastatin, a small-molecule drug candidate for the treatment and prevention of acute kidney injury (“AKI”).
With this license, Arch secures the commercial rights to the patents around the use of cilastatin that it does not already own. The patents held by Arch and Telara are now unified into one clinical development program to be led by Arch. These patents include method of use claims for the use of cilastatin as a potential drug to prevent AKI from a variety of causes including ischemia-reperfusion injury, sepsis and toxins.
Cilastatin is a known small molecule inhibitor of the enzyme dipeptidase-1 (DPEP-1) previously developed in the 1980s to prevent the degradation of the antibiotic imipenem in the kidney. In the past, cilastatin was used only as an active ingredient in a dual formulation with imipenem and has yet to be approved or sold as a stand-alone product.
The Arch team recently discovered that DPEP-1 is an adhesion receptor of neutrophil (white blood cell) recruitment in the lungs, liver and kidneys, a pathway that is targeted by Arch’s lead drug candidate Metablok (LSALT peptide). Currently, Arch is nearing completion of a Phase II trial for Metablok targeting this new pathway in the prevention of acute lung injury and AKI in COVID-19 patients.
Cilastatin inhibits DPEP-1 by binding to a different part of the DPEP-1 molecule than Metablok. Although DPEP-1 is expressed by the lungs, liver and kidneys, pre-clinical animal studies to date have shown that cilastatin is effective in preventing AKI induced by sepsis, ischemia-reperfusion injury and drugs/toxins. Unlike Metablok, cilastatin is not effective in preventing liver inflammation. Pre-clinical studies to assess cilastatin’s ability to prevent lung inflammation are still ongoing.
As a result, the license with Telara provides Arch a co-lead drug candidate in its next Phase II clinical trial which will target the prevention of AKI in human diseases outside of the COVID-19 pandemic. The new license further adds to the Arch pipeline of DPEP-1 targeting agents, which currently includes several other proprietary drug candidates besides Metablok.
As part of the license agreement and collaboration, the Telara team will provide to Arch the Phase I safety data and the newly established cilastatin drug manufacturing program to support a future Phase II trial application with regulatory agencies in Europe and North America.
CEO of Arch Biopartners, Richard Muruve, commented, “With the license of Telara’s cilastatin patent rights combined with our own, we look forward to doing a significant Phase II trial targeting ischemia reperfusion related AKI. Currently, there are no effective treatments to prevent AKI and Arch now has both Metablok and cilastatin that can be used in separate patient arms of a new Phase II trial. The collaboration with Telara will also facilitate a future drug application in Europe and potential patient recruitment in Spain.”