Dalton Pharma, Arch Biopartners in Mfg. Tie-up

08.17.18

Dalton to perform the GMP campaign for Metablok

Arch Biopartners has engaged Dalton Pharma Services to perform the good manufacturing practice (GMP) campaign for Metablok, (LSALT peptide), the company's drug candidate for preventing acute kidney injury.

Dalton will be responsible for the GMP preparation and filling of Metablok into glass vials through to the release of a clinical drug product. The clinical drug product will then form part of the intravenous kits that will be used to support the Phase I human trial to evaluate Metablok's safety and pharmacokinetic profile. The Phase I trial will serve as a precursor to future Phase II clinical trials to test Metablok's efficacy for several indications, the first being the prevention of acute kidney injury (AKI) often seen in patients undergoing cardiac surgery.

"Dalton is privileged to be supporting this critical GMP campaign, and to play an important role in the development of this innovative peptide drug for the treatment and prevention of acute kidney injury in cardiac surgery patients." said Peter Pekos, chief executive officer and president, Dalton Pharma Services. "The need for an effective therapeutic is badly needed as there is no such treatment currently for the more than one million patients that risk kidney damage during these procedures each year."

The Arch team continues to prepare an investigational new drug (IND) application for Metablok. "We have taken a significant step forward in the Metablok clinical program with our engagement with Dalton. We are on schedule for producing a GMP drug kit for Metablok to support the first human trial, which is a key component of our IND application that we expect to submit to the U.S. Food and Drug Administration later this year, "said Richard Muruve, chief executive officer, Arch.