Arch Biopartners Inc., (TSX-V: ARCH) (OTCQB: ACHFF) today announced that Dalton Pharma Services has completed the good manufacturing practice glass vial filling stage for Metablok, the Company’s lead drug candidate for preventing acute kidney injury.

Over the next six to eight weeks Dalton will be completing the quality control process which will culminate with the release of a clinical drug product to be used in a phase I safety trial for Metablok.

Arch awaits the completion of ongoing toxicology and pharmacology studies at Nucro-Technics in November before confirming the start date of the phase I human trial.

Arch is currently finalizing the planning of the Phase I trial including the selection of a clinical site. Arch plans to make further disclosures when such details are confirmed.

Cardiac Surgery-Associated Acute Kidney Injury 

Acute kidney injury (AKI) occurs in approximately 30% of patients that undergo cardiac bypass surgery with 1% of patients requiring dialysis. Currently, no specific therapies exist to prevent AKI. Worldwide, there are over one million patients per year that have cardiac surgery procedures.  

AKI represents an additional challenge in patients recovering from cardiac surgery as they have higher incidences of mortality, complications in treatment course, and higher risk of complications such as cardiovascular events and infection. Of the patients that require dialysis because of cardiac surgery-associated AKI, many will require lifelong dialysis which increases overall morbidity and mortality.

Inflammation is known to contribute to AKI related to ischemia-reperfusion and other insults to the kidney that may occur in the course of cardiac surgery.  Metablok is a novel therapeutic agent that may protect the kidneys and prevent AKI in patients undergoing cardiac surgery.

About Dalton: 

Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. Dalton brings over 30 years of experience to their client’s projects and emphasize quality, speed and flexibility.

Dalton can accelerate a drug development program by integrating drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing and Accelerated Stability Testing, all at a single location that helps Dalton to be adaptable, flexible and cost-effective.

CMO 2016, 2017 and 2018 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflects Dalton’s ongoing commitment to their clients, peers and the business community. In 2017 Dalton was re-certified as “A Great Place to Work.”

About Arch Biopartners

Arch Biopartners Inc. is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact.  Arch has established a diverse portfolio that includes Metablok (LSALT peptide), a potential treatment for inflammation, sepsis and cancer metastasis; AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung, urinary tract or wounds; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease bacterial biofilm on various medical grade metals and plastics.