Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Dalton Pharma, Arch Biopartners in Mfg. Tie-up | Contract Pharma

What are you searching for?

Sign in
Breaking News

Dalton Pharma, Arch Biopartners in Mfg. Tie-up

Dalton to perform the GMP campaign for Metablok

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

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.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics