vapendavir / Vaxart, Altesa BioSciences - LARVOL DELTA

Inflammatory biomarkers are reduced by vapendavir treatment in rhinovirus-challenged COPD patients (ERS 2026) - "VPV reduced peak serum IP-10 and was significantly (p<0.05) lower than placebo at 6 and 9 days after viral challenge. The reduction in inflammatory marketrs is consistent with, and provides a pathophysiologic explanation for, previously reported reductions in upper and lower respiratory symptoms, and improved quality of life in RV-challenged COPD patients treated with vapendavir compared to placebo."

Biomarker • Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Respiratory Diseases • CSF2 • IFNA1 • IFNL1

Cardinal COPD: Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Altesa Biosciences, Inc.

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Altesa Advancing the Development of Vapendavir in Phase 2b CARDINAL Study (PRNewswire) - "Altesa recently initiated its Phase 2b CARDINAL study that will run through Q4 2027. The multi-center, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of two doses of oral vapendavir compared with placebo in participants with COPD and confirmed rhinovirus infection. The trial will enroll 900 participants with GOLD Stage 2-4 COPD across 49 sites in the United States and United Kingdom and is event-driven to achieve 180 RV-positive participants randomized to a 7-day, once-daily treatment regimen."

Trial status • Chronic Obstructive Pulmonary Disease

Altesa BioSciences Presents Positive Phase 2 Challenge Study Results for Vapendavir at American Thoracic Society International Conference 2026 (PRNewswire) - "In the challenge study, vapendavir-treated patients showed: Reduced viral load, consistent with previous clinical trials in patients with asthma; Reduced inflammation reduced several clinically relevant chemokines measured; Improved median time to symptom resolution, a recommended pivotal trial outcome measure by FDA Division of Antivirals, was 5 days with vapendavir and 8.5 days with placebo– as measured by E-RS; Improved patient-reported outcomes, including a decrease in the number of subjects with a clinically meaningful worsening in St. George's Respiratory Questionnaire (SGRQ); Maintained small airway function as measured by oscillometry."

P2 data • Chronic Obstructive Pulmonary Disease

Treatment With Vapendavir After Rhinovirus Challenge in COPD Protects Lung Function and Accelerates Virus Clearance and Symptom Resolution - Results From a Phase 2A Randomised Double-Blind Placebo-Controlled Trial (ATS 2026) - No abstract available

Clinical • P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Altesa BioSciences said Thursday it raised an oversubscribed $75-million series B led by Forbion, with participation from Sanofi, to advance vapendavir, an oral antiviral designed to treat rhinovirus infections in patients with chronic obstructive pulmonary disease (COPD). (Firstwordpharma Press Release) - "The financing will fund the Phase IIb CARDINAL trial, which is expected to begin in the second quarter....The CARDINAL study will enroll 900 patients with COPD who will be monitored and randomised when they develop rhinovirus infection. Participants will receive one of two doses of vapendavir or placebo, with primary endpoints focused on patient-reported respiratory symptoms, and secondary measures including time-to-symptom resolution, lung function and use of healthcare resources."

Financing • New P2b trial • Chronic Obstructive Pulmonary Disease • Immunology

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: Altesa Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Session Conclusion and Overview of Clinical Plans for Vapendavir (ERS 2025) - "Sponsored by Altesa Biosciences, Inc."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Rhinovirus Challenge Study Background and Experience - Rhinovirus Challenge Study with Vapendavir Study Results (ERS 2025) - "Sponsored by Altesa Biosciences, Inc."

Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Vapendavir for the treatment of COPD patients challenged with rhinovirus: A phase 2a placebo-controlled study (ERS 2025) - "These results demonstrate a consistent beneficial effect of VPV on upper and lower respiratory symptoms in COPD patients challenged with RV and support the advancement of VPV into large scale randomized trials. Treament of RV may be a transformative therapeutic approach for people living with COPD and other chronic lung conditions."

Clinical • Late-breaking abstract • P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Respiratory Diseases

Structure-Activity Relationship Studies Towards Analogues of Pleconaril as Novel Enterovirus-D68 Capsid-Targeting Antivirals. (PubMed, bioRxiv) - "We present herein SAR and SPR studies of analogues of clinical compounds such as pleconaril and vapendavir against EV-D68 as a representative NPEV. Numerous structurally differentiated analogues with EV-D68 antiviral activity and useful ADME properties were discovered, which could serve as starting points for future EV drug discovery campaigns. Screening against a panel of enteroviruses revealed moderately broad-spectrum anti-EV activity of compound 26."

Journal

A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir (clinicaltrials.gov) - P1/2 | N=8 | Completed | Sponsor: Altesa Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion

Altesa BioSciences Details Positive Topline Vapendavir Results from Phase 2 Placebo-Controlled Rhinovirus Challenge Study in COPD Patients (PRNewswire) - P2 | N=52 | NCT06149494 | Sponsor: Altesa Biosciences, Inc. | "Altesa BioSciences...Altesa BioSciences today announced positive topline results from its Phase 2 placebo-controlled study examining the effects of vapendavir in COPD patients challenged with rhinovirus. In this study, treatment with vapendavir improved overall patient-reported measures of both upper and lower respiratory symptoms and led to a shortened overall course of illness. These positive effects were supported by a reduced level and faster resolution of viral loads in the respiratory system of participants treated with vapendavir....More detailed results from Altesa's Challenge Study will be submitted for presentation at a future medical congress."

P2 data • Chronic Obstructive Pulmonary Disease

A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: Altesa Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Altesa BioSciences Announces Clearance of Investigational New Drug (IND) Application for Vapendavir (PRNewswire) - "Altesa BioSciences, Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared Altesa's new Investigational New Drug (IND) application for vapendavir for the treatment of rhinovirus infections in people living with COPD. This milestone paves the way for Altesa to initiate clinical trials in the United States for this patient population."

IND • New trial • Infectious Disease

A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir (clinicaltrials.gov) - P1/2 | N=8 | Recruiting | Sponsor: Altesa Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection (clinicaltrials.gov) - P2 | N=52 | Active, not recruiting | Sponsor: Altesa Biosciences, Inc. | Recruiting ➔ Active, not recruiting | N=100 ➔ 52 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment change • Enrollment closed • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir (clinicaltrials.gov) - P1/2 | N=8 | Not yet recruiting | Sponsor: Altesa Biosciences, Inc.

New P1/2 trial

Emerging Therapeutics in the Fight Against EV-D68: A Review of Current Strategies. (PubMed, Influenza Other Respir Viruses) - "WIN-like compounds (pleconaril, pocapavir, and vapendavir) bind to the virus capsid and have been tested against various enteroviruses (EVs) in clinical trials...Ongoing research efforts are dedicated to identifying viable therapeutics to address EV-D68 infections. This review explores the current advancements in antiviral therapies and potential therapeutics to mitigate the significant impact of EV-D68 infection control."

Journal • Review • CNS Disorders • Infectious Disease • Pediatrics

New potent EV-A71 antivirals targeting capsid. (PubMed, Eur J Med Chem) - "Targeting the well-known hydrophobic pocket in the viral capsid, these compounds show micromolar activity against EV-A71 and a high selectivity index (SI) (5h: EC50, MRC-5 = 0.57 μM, CC50, MRC-5 >20 μM, SI > 35; EC50, RD = 4.38 μM, CC50, RD > 40 μM, SI > 9; 6c: EC50, MRC-5 = 0.29 μM, CC50, MRC-5 >20 μM, SI > 69; EC50, RD = 1.66 μM, CC50, RD > 40 μM, SI > 24; Reference: Vapendavir EC50, MRC-5 = 0.36 μM, CC50, MRC-5 > 20 μM, EC50, RD = 0.53 μM, CC50, RD > 40 μM, SI > 63). The binding mode of these compounds in complex with enterovirus capsids was analyzed and showed a series of conserved interactions. Consequently, 6c and its derivatives are promising candidates for the treatment of enterovirus infections."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Altesa Biosciences, Inc. | Enrolling by invitation ➔ Completed | Trial completion date: Aug 2023 ➔ May 2024 | Trial primary completion date: Aug 2023 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Altesa Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Altesa Biosciences, Inc.

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD (clinicaltrials.gov) - P1 | N=24 | Enrolling by invitation | Sponsor: Altesa Biosciences, Inc.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Altesa BioSciences Announces Scientific Advisory Board (Businesswire) - "Altesa BioSciences, Inc...today announced the inaugural members of its Scientific Advisory Board (SAB). The SAB comprises leading academic and industry leaders in pulmonology, infectious diseases, virology, pediatrics and drug development....'This SAB possesses the experience and vision to assist in advancing our first clinical-stage drug, Vapendavir, into advanced clinical trials to improve the lives of patients living with chronic obstructive pulmonary disease (COPD).'...The inaugural members of the Altesa Biosciences SAB...MeiLan K. Han, MD, MS..."

Announcement