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Respiratory Diseases

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Urogenital Diseases

Monoclonal antibody

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Top 5 Drug Type	Count

Monoclonal antibody	1

Top 5 Target	Count

NAMPT(Nicotinamide phosphoribosyltransferase)	1

ALT-100 is a monoclonal antibody developed by Aqualung Therapeutics Corp. as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS can occur as a serious complication in patients with respiratory infections such as COVID-19 and Influenza or have acquired trauma to their lungs. 32 healthy male or female participants between the ages of 18 and 55 years will be enrolled into 4 cohorts of single ascending doses. The doses being investigated are 0.1mg/kg, 0.4mg/kg, 1mg/kg and 4mg/kg administered by intravenous infusion. Participants will be screened within 28 days of study treatment, be admitted to the clinical research unit for 3 nights and attend 7 outpatient visits on study days 8, 15, 22, 29, 60, 90 and 120 respectively. This study will collect data to evaluate safety and tolerability, Pharmacokinetics of ALT-100, Pharmacodynamics of ALT-100 and determine if Anti-drug Antibodies are produced in the participants.

Start Date05 Jul 2022

Sponsor / Collaborator

Aqualung Therapeutics Corp.

100 Clinical Results associated with Aqualung Therapeutics Corp.

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0 Patents (Medical) associated with Aqualung Therapeutics Corp.

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1

Literatures (Medical) associated with Aqualung Therapeutics Corp.

01 Sep 2024·Journal of clinical research and clinical trials

Safety, Tolerability and Pharmacokinetics of the eNAMPT-Neutralizing ALT-100 Mab in Healthy Volunteers.

Article

Author: Mantovani, Susanna ; Polasek, Thomas ; Camp, Sara M ; Garcia, Joe G N ; Miele, Stan

Introduction:

Human and preclinical studies have highlighted eNAMPT (extracellular nicotinamide phosphoribosyl transferase) as a druggable TLR4 ligand and DAMP involved in the pathobiology of diverse inflammatory, fibrotic and cancer disorders. This Phase 1 study assesses the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the humanized eNAMPT-neutralizing ALT-100 mAb as a strategy to address the unmet need for effective anti-inflammatory, anti-fibrotic therapeutics.

Materials and Methods:

Healthy male and female volunteers received a single intravenous ALT-100 dose (0.1, 0.4, 1.0, 4.0 mg/kg, n=24 dosed) or placebo (n=12 dosed) with 120-day monitoring (injection site, vital signs, hematology, coagulation, blood chemistry, urinalysis, PK/PD parameters, plasma biomarkers, anti-drug antibodies).

Results:

ALT-100 was well tolerated at all doses without clinically significant changes in local tolerability, vital signs, or laboratory safety parameters. Treatment-emergent adverse events (TEAEs) were unrelated to ALT-100 mAb dose (mild/moderate in severity), and AEs were transient and resolved without clinical sequelae. There were no serious adverse events (SAEs). Median ALT-100 mAb plasma levels peaked at 0.62 hour after dosing (all doses). The mean maximum mAb plasma concentration (C_max) and mAb elimination half-life (T1/2) all increased in a dose-related manner between 0.4 mg/kg (17 days) and 4 mg/kg (27 days).

Conclusions:

Single intravenous ALT-100 mAb doses are well tolerated in healthy participants with dose proportional PK and elimination half-life.

100 Deals associated with Aqualung Therapeutics Corp.

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100 Translational Medicine associated with Aqualung Therapeutics Corp.

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Pipeline

Pipeline Snapshot as of 28 Mar 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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