Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD

NCT07610395 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALT-VPV-203
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 14

Brief Summary

Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.

Conditions

Rhinovirus Infection

Outcome Measures

Primary Outcomes (1)

• Evaluating Respiratory Symptoms (E-RS)

  11-item E RS collected as part of the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT PRO®) scale, with data from the additional 3 items from the EXACT PRO scale used for exploratory purposes only. The PSB will be calculated as the mean of the E-RS scores collected in the -35 to -6 days prior to RV symptom onset. If the E-RS score has not returned to PSB at the time of Day 28 Visit, the participant will complete the E-RS daily until Day 42. The questions are asked about how the participant feels today and will be collected at night.

  Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

Secondary Outcomes (15)

• Patient Global Impression of Severity (PGIS)

  Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

• Wisconsin Upper Respiratory Symptom Survey - 11

  Treatment/Follow-up Periods: Daily for 28 days

• Change from Baseline in Respiratory System Resistance at 5 Hz (R5) Measured by Oscillometry

  Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

• Change from Baseline in Respiratory System Resistance at 20 Hz (R20) Measured by Oscillometry

  Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

• Change from Baseline in Frequency Dependence of Resistance (R5-R20) Measured by Oscillometry

  Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

Study Arms (3)

Dosing Group 1 VPV 1000 mg

EXPERIMENTAL

The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.

Drug: VPV 1000 mg

Dosing Group 2 VPV 500 mg

EXPERIMENTAL

The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.

Drug: VPV 1000 mg; Drug: VPV 500 mg

Dosing Group 3 Placebo

PLACEBO COMPARATOR

The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses

Other: Placebo

Interventions

VPV 1000 mg DRUG

Vapendavir 1000 mg

Also known as: Vapendavir

Dosing Group 1 VPV 1000 mg; Dosing Group 2 VPV 500 mg

VPV 500 mg DRUG

Vapendavir 500 mg

Also known as: Vapendaivr

Dosing Group 2 VPV 500 mg

Placebo OTHER

Placebo

Dosing Group 3 Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening.
• If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received.
• Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio \<0.70 and post bronchodilator FEV1 ≥20% and \<80% of predicted normal value).
• History of AECOPD with at least 1 documented AECOPD within 1 year of Screening. AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for 2 days
• Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)
• Use of oral or systemic steroids (Moderate Exacerbation), or
• Use of Antibiotics (Moderate Exacerbation), or
• Emergency room visit or hospitalization (Severe Exacerbation).
• CAT score ≥10 at screening.
• Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms.
• Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home.

You may not qualify if:

• If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable).
• Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization.
• The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test.
• To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.

Sponsors & Collaborators

• Altesa Biosciences, Inc.: lead

Study Sites (14)

AMR Clinical - Tempe

Tempe, Arizona, 85281, United States

RECRUITING

NewportNativeMD, Inc.

Newport Beach, California, 92663, United States

RECRUITING

Apex Clinical Research

San Diego, California, 92120, United States

RECRUITING

VM Clintrials

Miami Lakes, Florida, 33014, United States

RECRUITING

Accelerated Clinical Trials, LLC

Snellville, Georgia, 30078, United States

RECRUITING

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

RECRUITING

Patient First Clinical Trials (PFCTRIALS)

Lutherville, Maryland, 21093, United States

RECRUITING

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

RECRUITING

CRC Kings Mountain

Kings Mountain, North Carolina, 28086, United States

RECRUITING

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

RECRUITING

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, 15801, United States

RECRUITING

Preferred Primary Care Physicians - St. Clair

Pittsburgh, Pennsylvania, 15423, United States

RECRUITING

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

MeSH Terms

Interventions

VEP combination

Central Study Contacts

Karen Fusaro

CONTACT

610-242-0903; kfusaro@altesa.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

US (14)