RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

NCT06149494 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALT VPV-202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

Conditions

COPD Exacerbation Acute; COPD With Acute Lower Respiratory Infection; Rhinovirus; Virus Diseases; Virus Infection, RNA; Enterovirus; Enterovirus Infections; Rhinovirus Infection; Infection Viral; Respiratory Complication; Respiratory Disease; Respiratory Tract Infections; Respiratory Tract Diseases; Respiratory Viral Infection; Upper Resp Tract Infection; Upper Respiratory Tract Infections; Upper Respiratory Disease; Upper Respiratory Disorder; Upper Respiratory Disease, Acute; Upper Respiratory Infection Viral; Infections, Respiratory; Infections; Copd; Viral Infection; Emphysema or COPD; Lower Respiratory Disorder; Lower Respiratory Tract and Lung Infections; Pulmonary Disease; Pulmonary Disease, Chronic Obstructive; Respiratory Disease Chronic; Lung Diseases; Lung Disease Chronic; Obstructive Pulmonary Disease; Chronic Lower Respiratory Diseases; Chronic Respiratory Disease; Lower Respiratory Disease

Keywords

Randomized; Double-blind; Phase 2; Placebo-Controlled; Clinical study; Clinical trial; Randomization; Interventional

Outcome Measures

Primary Outcomes (1)

• Peak change from baseline

  • Evaluation of the peak total lower respiratory symptom score (LRSS) in participants administered with VPV relative to/versus (vs) placebo as determined by Mallia et al (Am J Respir Crit Care Med. 2011) from day of treatment commencement until Day 42. This is a measure of a number of lower respiratory symptoms in a 24 hour period that include: shortness of breath (scale 0-4; 0 = not breathless, 4 = breathless at rest) wheeze (0-4; 0 = no wheeze, 4 = wheeze at rest), cough (0-3; 0 = no cough, 3 = severe cough), sputum quantity (0-3; 0 = none, 3 = large volume , more than 100 ml) sputum quality (0-3; 0 = none, 3 = purulent, green in colour). The total lower respiratory symptom score is the sum of all the above measurements (minimum 0, maximum 17) recorded on each day. These values will be recorded via a study diary over a six week period (day 0-42). Peak value is the highest daily total value over the 6 week post-infection period.

  From Baseline Visit through Follow-Up Visit, up to 7 weeks

Secondary Outcomes (8)

• Peak COPD Specific Respiratory Symptoms

  Day of treatment commencement to Day 42

• Peak Upper Respiratory Symptoms

  Day of treatment commencement to Day 42

• Peak Overall Symptom severity

  Day of treatment commencement to Day 42

• Peak Virus Load as measured in RNA copies per mL

  Day of treatment commencement to Day 42

• Peak Sputum Bacterial Load

  Day of treatment commencement to Day 42

Study Arms (2)

Vapendavir Cohort

EXPERIMENTAL

VPV will be dispensed by the study team on Day 0 at the clinical study visit at the study site. Participants will be given enough VPV for the 7-day treatment phase, (eg. Days 2 to 8). Treatment is twice daily, am and pm, 12 h apart ± 2 h. VPV micronized free base tablets (250 mg each) will be given orally beginning with a 1,000 mg loading dose (4 tablets) as soon as symptoms are present or the subject answers "yes" to "do you think you have a cold today" followed by 500 mg (2 tablets) either on the same day (eg day 2) or the next day. Treatment will therefore be for a total of 7 days consisting of an initial 1,000 mg dose (4-tablets) followed by thirteen 500mg doses (2-tablets). Treatment may occur within the home, on non-clinical study days.

Drug: Vapendavir

Placebo Cohort

PLACEBO COMPARATOR

Placebo will be dispensed by the study team on Day 0 at the clinical visit at the study site. Participants will be given enough Placebo for the 7-day treatment phase, (eg. Days 2 to 8). Treatment is twice daily, am and pm, 12 h apart ± 2 h. Placebo tablets will be matched to the active treatment and will be administered orally for 7 days as follows: 4 tablets for the initial dose as soon as symptoms are present or the subject answers "yes" to "do you think you have a cold today" on the first day of dosing (eg. Day 2), and 2 tablets, either on the same day (eg Day 2) or the next day. Treatment will therefore be for a total of 7 days (consisting of an initial 4-tablet dose followed by thirteen 2-tablet doses). Treatment may occur within the home, on non-clinical study days.

Drug: Placebo

Interventions

Vapendavir DRUG

Participants randomized to the experimental cohort will be administered Vapendavir.

Vapendavir Cohort

Placebo DRUG

Participants randomized to the placebo cohort will be administered placebo.

Placebo Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥40 years and ≤75 years at the time of signing the informed consent form.
• If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective forms of contraception ≥ 28 days prior to the first dose (females), during the study period (both males and females) and for 30 days (females) or 90 days (males) after the last dose. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly.
• Males (including those with a vasectomy): agree to use a condom and if a female partner of childbearing potential, use of at least one other contraceptive method; males must also agree not to donate sperm within 90 days after the last dose).
• WOCBP participants must use at least one highly effective contraceptive method.
• Birth control methods which may be considered as highly effective:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
• oral
• intravaginal
• transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation
• oral
• injectable
• implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system ( IUS)

You may not qualify if:

• Participants with other causes of chronic airflow limitation:
• Including but not limited to: Asthma (mixed COPD and asthma is acceptable); cystic fibrosis (CF); bronchiolitis obliterans; and fibrosis such as tuberculosis (TB), idiopathic pulmonary fibrosis (IPF), or other major respiratory diagnosis (e.g., pneumonia, aspergillosis), etc.
• Non-CF bronchiectasis
• Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled.
• Prescription or over-the-counter medications or herbal products that could be impacted by CYP3A4 and CYP 2C19 induction or inhibition and have serious complications for the participant within the treatment period without the ability to discontinue safely with a sufficient washout period before initiating VPV.
• Patients on oral contraceptives or estrogen containing hormone replacement therapy.
• Ingestion of grapefruit, pomegranate, star fruit and Seville oranges within 14 days prior to dosing. The juices and products containing these fruits should also be avoided.
• History of clinically significant infection (respiratory or non-respiratory) requiring antibiotic or systemic steroids \>10 mg/day within 30 days prior to planned RV challenge.
• Pregnant, planning to become pregnant, testing positive for pregnancy at the screening visit test, or nursing females during and within 30 days of treatment.
• Any cold symptom within the last 6 weeks such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
• Presence (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in four (≥1/4) dilution.
• Active allergic rhinitis, active nasal disease such as nasal polyposis, chronic rhinosinusitis etc.
• Active alcohol and/or drug misuse, at the discretion of the Investigator.
• Use of any over the counter cold prophylaxis products including nasal sprays, C-vitamins, zinc or Echinacea within 1 month prior to the enrolment.
• Participation in other clinical trial with medical investigational product within 30 days or 5 drug half-lives (whichever is longer) prior to enrolment.

Sponsors & Collaborators

• Altesa Biosciences, Inc.: lead
• Virtus Respiratory Research: collaborator

Study Sites (1)

St. Mary's Hospital - Imperial College Respiratory Research Unit (ICRRU)

London, W2 1NY, United Kingdom

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Virus Diseases; RNA Virus Infections; Enterovirus Infections; Respiration Disorders; Respiratory Tract Infections; Respiratory Tract Diseases; Common Cold; Infections; Pulmonary Disease, Chronic Obstructive; Emphysema; Lung Diseases; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Picornaviridae Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Onn Min Kon, MD

  Imperial College Healthcare

  PRINCIPAL INVESTIGATOR

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: October 11, 2023
• First Posted: November 29, 2023
• Study Start: November 20, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)