SP16 / Serpin Pharma - LARVOL DELTA

SP16 as a Therapeutic for COVID-19 Induced ARDS (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Serpin Pharma, LLC | Phase classification: P1/2 ➔ P1 | N=20 ➔ 2 | Trial completion date: Mar 2024 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2023 ➔ Jun 2023; Trial was terminated due to lack of patients.

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • A2M • IL1B • IL6 • TNFA

Restoration of CD4+ T helper cells without modulating the hepatic inflammatory pattern is not sufficient to prevent HCC (P884) (IMMUNOLOGY 2023) - "These data suggest that the hepatic immune pattern, which could produce a collective function independent from its cellular components, is more important than CD4+ T cell recovery during disease progression. Our data also suggest that administration of SP16 very early during NAFLD could shift a predominant Th1 pattern towards an equilibrium Th1=Th2=Th17 pattern which has been found to protect DIAMOND mice from from the progression of NAFLD to HCC.  Future studies will determine if modulation of the inflammatory immune response by SP16 when administered early during NAFLD progression will prevent HCC."

Addiction (Opioid and Alcohol) • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Non-alcoholic Fatty Liver Disease • Oncology • Solid Tumor • CD4

SERPIN-Derived Small Peptide (SP16) as a Potential Therapeutic Agent against HIV-Induced Inflammatory Molecules and Viral Replication in Cells of the Central Nervous System. (PubMed, Cells) - "Using an in vivo mouse model, we showed that SP16 was transported across the BBB after intranasal delivery, while animals infected with EcoHIV undergo a reduction in (i) viral replication and (ii) viral secreted inflammatory molecules, after exposure to SP16 and antiretrovirals. Overall, these studies confirm a therapeutic response of SP16 against HIV-associated inflammatory effects in the brain."

Journal • Dyslipidemia • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • AKT1 • NF-κβ

Restoration of CD4 T Cells during NAFLD without Modulation of the Hepatic Immunological Pattern Is Not Sufficient to Prevent HCC. (PubMed, Cancers (Basel)) - "However, SP16 administered early during NAFLD progression modulated the inflammatory profile. Future studies will determine if regulation of the inflammatory immune response by SP16 early in NAFLD progression will prevent HCC."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Inflammation • Non-alcoholic Fatty Liver Disease • Oncology • Solid Tumor • CD4

Safety, tolerability and effects of a single subcutaneous administration of SP16-a SERPIN-like, small peptide agonist of the Low-Density Lipoprotein-like Receptor 1 -on the acute inflammatory response in patients with ST-segment elevation Myocardial Infarction (STEMI). (PubMed, J Cardiovasc Pharmacol) - "A single subcutaneous administration of SP16, a synthetic targeted LRP1 agonist, was safe and well tolerated in patients with STEMI. A trend toward reduction in the inflammatory response and infarct size with SP16 was noted; however, the sample size for this study was not based upon formal statistical criteria. More extensive studies are planned to determine the clinical efficacy of SP16 in STEMI."

Journal • Cardiovascular • Dyslipidemia • Inflammation • Myocardial Infarction • LRP1

SPIRIT: SP16 Inflammatory Response Inhibition Trial (clinicaltrials.gov) - P1/2; N=10; Completed; Sponsor: Serpin Pharma, LLC; Active, not recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Dec 2021

Trial completion • Trial completion date • Cardiovascular • Immunology • Inflammation • Myocardial Infarction • CRP

SP16 as a Therapeutic for COVID-19 Induced ARDS (clinicaltrials.gov) - P1/2; N=20; Recruiting; Sponsor: Serpin Pharma, LLC; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • A2M • CXCL8 • IL1B • IL6 • TNFA

α1-Antitrypsin derived SP16 peptide demonstrates efficacy in rodent models of acute and neuropathic pain. (PubMed, FASEB J) - "SP16 also attenuated innate immunity in the PNS. These studies identify SP16 as a potentially effective treatment for pain."

IO biomarker • Journal • Preclinical • Dyslipidemia • Immunology • Inflammation • Neuralgia • Pain • GFAP • ITGAM • LRP1 • TLR4

SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS (clinicaltrials.gov) - P1/2; N=20; Not yet recruiting; Sponsor: Serpin Pharma, LLC

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • A2M • CXCL8 • IL1B • IL6 • TNFA

A phase 1 clinical trial of SP16, a first-in-class anti-inflammatory LRP1 agonist, in healthy volunteers. (PubMed, PLoS One) - "A one-time treatment with SP16 for doses up to 0.2 mg/kg or 12 mg was safe in healthy volunteers."

Clinical • Journal • P1 data • Dyslipidemia • Hematological Disorders • Pain • AAT • LRP1

SPIRIT: SP16 Inflammatory Response Inhibition Trial (clinicaltrials.gov) - P1/2; N=10; Active, not recruiting; Sponsor: Serpin Pharma, LLC; Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Immunology • Inflammation • Myocardial Infarction • CRP

FDA gives Manassas-based Serpin Pharma go-ahead for clinical investigation in COVID-19 drug (WTOP) - "Manassas-based Serpin Pharma has been notified by the U.S. Food and Drug Administration that it may proceed with its proposed clinical investigation for the use of SP16....'We are delighted with the FDA decision to approve the IND [Investigational New Drug Application] allowing Serpin Pharma to move forward with a clinical investigation of SP16 for treatment of the COVID-19 disease,' said Dr. Cohava Gelber, Chief Executive Officer, Serpin Pharma. "

Cytokine storm • IND • New trial • Infectious Disease • Novel Coronavirus Disease