Arch Biopartners Inc V.ARCH

Arch BioPartners - LSALT Peptide Development

[Riverfolk]

Arch believes that LSALT peptide has the potential to deliver a major breakthrough in the treatment of diseases where inflammation plays a major role.

• In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation

• In December 2019, the U.S. Patent and Trademark Office (USPTO) has issued to Arch U.S. Patent number 10,493,127 titled, “Dipeptidase-1 Binding Compositions and Methods of Treatment”.

  This is the first patent issued protecting the method of use for the dipeptidase-1 (DPEP-1) inhibitor, cilastatin, for ischemia reperfusion injury, where DPEP-1 mediated inflammation plays a major role.

• In March 2020, A total of 52 healthy, normal volunteers received dosing of Metablok during the Phase I study. All participants received either a low, medium or high dose of Metablok, either as a one-time dose or a daily dose over three days. In all cases, Metablok was well tolerated during the placebo-controlled trial and no significant drug-related adverse effects were observed.

• In Dec 2021, Sixty-one patients were enrolled in the study and randomized 1:1 to receive LSALT or placebo. Despite having older patients and having greater co-morbidities in the LSALT group, the unadjusted analysis of all patients in the trial demonstrated 22.8 ventilation-free days for the LSALT group compared to 20.9 days in the placebo group during the 28-day evaluation period. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT group vs. placebo.

• In March 2022, a scientific team led by Dr. Daniel Muruve at the University of Calgary, and their collaborators, have published a paper in the journal Science Advances describing the mechanism of action for dipeptidase-1 (DPEP-1) in acute kidney injury (AKI). Dr. Muruve is also the Chief Science Officer of Arch.

• In April 2023, Six participants in each group received a daily dosing of LSALT peptide for one day followed by three consecutive days of dosing. Two people per group received a placebo with the same dosing schedule. In the first group, six people received a once daily, 10 mg intravenous (IV) dose of LSALT peptide. In the second group, six volunteers received a 10 mg IV dose of LSALT peptide twice a day, approximately every 12 hours.

In both groups, LSALT peptide met the primary endpoints of safety and tolerability. Prior to this dose escalation trial, LSALT peptide was administered at a maximum of 5mg once daily, for up to 14 days, in hospitalized COVID-19 patients during a Phase II trial targeting inflammation in the lungs.
 

• In June 2023 Arch advanced the production of a new supply of LSALT peptide to be used in new human trials. The production of approximately 10,000 LSALT peptide drug product vials were recently completed and have been released for human use to support human trials. The new vials completed quality control and quality assurance procedures at the Company’s third-party manufacturing facility and have been moved to storage, pending delivery to clinical sites.

• In March 2024, ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

• In March 2024, Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19). Collectively, a greater proportion of the biomarkers decreased from baseline at day 3 and EOT in the LSALT peptide treatment group compared with placebo (63.1% vs 54.8%, OR 1.41 95% CI 1.13 to 1.75, p=0.003)

• Role of CXCL10 in Renal Diseases 

• In the last few years, strong experimental and clinical evidence has indicated that CXCL10 is involved in the development of renal diseases through the chemoattraction of inflammatory cells and facilitation of cell growth and angiostatic effects.