LAT8881 / Lateral Pharma - LARVOL DELTA

Lat peptides, non-opioid therapeutic candidates for neuropathic pain (NeuPSIG 2025) - "Collectively, this data suggests that the function and viability of stressed sensory neurons is positively impacted by acute treatment with LAT8881. Further work is needed to establish the mechanistic link between LanCL proteins, the neuronal effects and relief of neuropathic pain hypersensitivity."

CNS Disorders • Neuralgia • Pain

Cumulative benefits from chronic subcutaneous dosing of the lat peptides in a rodent model of neuropathy (NeuPSIG 2025) - "Background & Aims: The LAT peptides (e.g. LAT8881), acting via a novel target, the LanC-like (LanCL) protein family, have demonstrated analgesic properties following single administration in rodent neuropathic pain models and clinical proof-of-concept in patients with chronic lumbar radicular pain (LRP).Here we report on studies with the LAT peptides aimed at: a) excluding interactions with opioid receptors or other biological targets that may lead to abuse or dependence, b) investigating any unintended changes in behavioural or physiological state in rodents, and c) investigating analgesia following chronic daily subcutaneous (SC) dosing in the rat L5 spinal nerve ligation model (Chung model). The in vitro functional screens included assays against: (i) 78 GPCR, enzyme, ion channel, neurotransmitter transporters, and nuclear hormone receptors at 10 concentrations across 4 log orders, (ii) µ-, κ-, and δ-opioid receptors in agonist, antagonist and positive..."

Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Neuralgia • Pain

Putative Plasma PD Biomarkers Identified from Clinical Study of LAT8881 in Lumbar Radicular Pain (IASP 2024) - "Having demonstrated clinical "proof-of-concept" of LAT8881 as a novel first-in-class therapeutic for the treatment of neuropathic pain, proteomic analysis of plasma samples taken from the study subjects has identified a number of differentially expressed proteins in LAT8881 treated subjects, particularly at 1 hour post-dosing. These results could provide the foundation for a pharmacodynamic assay of LanCL target engagement, which would aid screening of potential LAT therapeutics and support investigations into optimal dosing of these therapeutics in future clinical trials. We also observed differences between healthy volunteers and LRP subjects in expression of a number of proteins, including CRP; a larger sample size (only samples from 3 healthy volunteers were included in this analysis) may be more informative."

Biomarker • Clinical • Inflammation • Neuralgia • Pain • CRP

Harnessing endogenous peptide compounds as potential therapeutics for severe influenza. (PubMed, J Infect Dis) - "These findings provide preclinical evidence that therapeutic LAT9997 treatment limits viral burden and characteristic features of severe influenza, including hyperinflammation and lung damage."

Journal • Infectious Disease • Inflammation • Influenza • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Investigational Drugs for the Treatment of Postherpetic Neuralgia: Systematic Review of Randomized Controlled Trials. (PubMed, Int J Mol Sci) - "A total of 18 clinical trials were selected evaluating 15 molecules with pharmacological actions on nine different molecular targets: Angiotensin Type 2 Receptor (AT2R) antagonism (olodanrigan), Voltage-Gated Calcium Channel (VGCC) α2δ subunit inhibition (crisugabalin, mirogabalin and pregabalin), Voltage-Gated Sodium Channel (VGSC) blockade (funapide and lidocaine), Cyclooxygenase-1 (COX-1) inhibition (TRK-700), Adaptor-Associated Kinase 1 (AAK1) inhibition (LX9211), Lanthionine Synthetase C-Like Protein (LANCL) activation (LAT8881), N-Methyl-D-Aspartate (NMDA) receptor antagonism (esketamine), mu opioid receptor agonism (tramadol, oxycodone and hydromorphone) and Nerve Growth Factor (NGF) inhibition (fulranumab). AT2R antagonism, AAK1 inhibition, LANCL activation and NGF inhibition are considered first-in-class analgesics. Hopefully, these trials will result in a better clinical management of PHN."

Journal • Review • Neuralgia • Pain

A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Lateral Pharma Pty Ltd | Recruiting ➔ Completed

Trial completion • Pain

Naturally derived cytokine peptides limit virus replication and severe disease during influenza A virus infection. (PubMed, Clin Transl Immunology) - "LAT8881 treatment in combination with the antiviral oseltamivir phosphate led to more pronounced reduction in markers of disease severity than treatment with either compound alone. These studies provide the first evidence identifying LAT8881 and LAT9991F as novel host-protective therapies that improve survival, limit viral replication, reduce local inflammation and curtail tissue damage during severe IAV infection. Evaluation of LAT8881 and LAT9991F in other infectious and inflammatory conditions of the airways is warranted."

Journal • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Influenza • Obesity • Osteoarthritis • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Lateral Pharma Pty Ltd | Trial completion date: Nov 2022 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Pain

A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Lateral Pharma Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Lateral Pharma Pty Ltd

New P1 trial • Pain

Oral LAT8881 in Neuropathic Pain (clinicaltrials.gov) - P2a; N=52; Completed; Sponsor: Lateral Pharma Pty Ltd; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine (clinicaltrials.gov) - P2; N=26; Completed; Sponsor: Lateral Pharma Pty Ltd; Recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Migraine

Oral LAT8881 in Neuropathic Pain (clinicaltrials.gov) - P2a; N=55; Active, not recruiting; Sponsor: Lateral Pharma Pty Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine (clinicaltrials.gov) - P2; N=26; Recruiting; Sponsor: Lateral Pharma Pty Ltd

Clinical • New P2 trial

Oral LAT8881 in Neuropathic Pain (clinicaltrials.gov) - P2a; N=55; Recruiting; Sponsor: Lateral Pharma Pty Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open