Arch Biopartners Inc V.ARCH

Alternate Symbol(s): ACHFF

Technology Scientific & Technical Instruments

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury. The Company is developing a platform of new drugs to prevent inflammation injury in the kidneys, lungs and liver via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem. The Company’s lead drug candidate is LSALT Peptide. The Company is engaged in the clinical development of LSALT Peptide and other DPEP-1 targeting drug candidates for indications where inflammation of the lungs, liver and kidneys is an unmet problem. LSALT Peptide is in a second phase II trial, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The Company has additional technology platforms in its portfolio, which are AB569 and Borg. AB569 is an anti-infective candidate for treating or preventing antibiotic resistant bacterial infections, primarily as a topical treatment for wounds.

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Arch Biopartners Inc

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Post by Riverfolkon Nov 10, 2023 10:07am

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Arch Biopartners - Underlying Fundamentals

Arch Biopartners is a late stage clinical trail company focused on preventing inflammation and organ injury.

Arch has built a novel, therapeutic drug platform of new candidates led by LSALT PEPTIDE , developed to inhibit inflammation in the:

Publications:

Human Trials:

2020 - Phase I Trial
2021 - Phase II Lung Trial - Positive effect observed
2022 - Phase III - Canadian Arm of the SOLIDARITY trial - No Results
2023 - Phase I - Dose Escalation from 5mg to 20Mg
2023 - Phase II International AKI trial - U.S / Turkey / Canada

Overview of Top-line Phase II Results

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 average number of ventilation-free days was 6.7 days less in the LSALT group of patients than the placebo group.

There were no unexpected differences in adverse events between LSALT and placebo treated patients. LSALT was well tolerated with no safety issues related to the drug. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance.

The patients enrolled in both the placebo and drug groups of the Phase II trial, for the most part, did not experience AKI. This was consistent between all clinical sites in Canada, United States and Turkey.

Phase II results also provide a first-ever signal towards validating Dipeptidase-1’s role in the mechanism of action of organ inflammation in humans.

2023 Q3 Management Discussion and Analysis

Non Dilutive Funding:

Insider Ownership:

CEO - Richard Muruve - 11,831,700 shares - 18.96% of outstanding shares
Outstanding insiders (Ink Research) 16,352,232 - 26.20% of outstanding shares

Patents:

Historic Private Placements:

2020 - $500,000 USD
2020 - $1,000,000 USD

License Agreements:

2021 - Cilastatin

Strategic Advisors:

Manufacturing of LSALT Peptide:

During the calendar year 2022 and the first half of 2023, the Company actively developed the manufacturing capability to produce LSALT Peptide at the standard required to enable phase II and III trials, as well as future drug approval and commercial scale production.
2023 Q3 Management Discussion and Analysis

Outstanding Share Data Aug 29, 2023