Dalton to manufacture Arch's peptide drug candidate ahead of Ph I trial
Dalton Pharma Services is a contract development and manufacturing organization (CDMO) providing integrated chemistry, drug development, and manufacturing services.
Under the agreement, Dalton is responsible for the good manufacturing practice (GMP) preparation and filling of Arch Biopartners' drug candidate, Metablok, into glass vials.
Metablok is a peptide being explored to prevent inflammation, sepsis ,and cancer metastasis. Arch Biopartners plans to trial the treatment in Phase I in patients who are undergoing cardiac surgery, to prevent acute kidney injury (AKI).
According to the company, 30% of patients receiving this type of surgery will experience AKI, with 1% of patients requiring dialysis. Currently, there are no therapies on the market specifically designed to treat AKI.
Earlier this year, Arch Biopartners completed a successful pre-investigation new drug (IND) application with the US Food and Drug Administration (FDA).
In the press release announcing the partnership, Arch Biopartners CEO Richard Muruve stated that acquiring Dalton’s services was a significant step in the developmental process for Metablok: “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 FDA later this year.”
On the company’s website, the firm states that it will be in a position to apply for an IND by the end of the third quarter of this year, before then entering clinical trials.
