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

• Status: Recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Altesa Biosciences, Inc.
• Collaborator: Virtus Respiratory Research

Criteria

Inclusion Criteria:

1. Male or female age ≥40 years and ≤75 years at the time of signing the informed consent form.

2. 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)

• bilateral tubal occlusion

• vasectomised partner

3. Confirmed diagnosis of Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) stage II COPD as defined by % predicted Forced expiratory volume in 1 second (FEV1) ≥50% and FEV1/Forced vital capacity (FVC) <70%.

4. History of acute exacerbations of COPD as defined by the participant answering "yes" to the question "do your COPD symptoms get noticeably worse when you catch a cold?"

5. If on maintenance therapy, be medically stable for at least 2 months prior to enrolment.

6. Clinically stable with no exacerbations within 2 months prior to enrolment.

7. Ability to understand and give informed consent.

Exclusion Criteria:

1. Participants with other causes of chronic airflow limitation:

1. 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.

2. Non-CF bronchiectasis

2. 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.

3. 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.

4. Patients on oral contraceptives or estrogen containing hormone replacement therapy.

5. 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.

6. 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.

7. Pregnant, planning to become pregnant, testing positive for pregnancy at the screening visit test, or nursing females during and within 30 days of treatment.

8. Any cold symptom within the last 6 weeks such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.

9. Presence (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in four (≥1/4) dilution.

10. Active allergic rhinitis, active nasal disease such as nasal polyposis, chronic rhinosinusitis etc.

11. Active alcohol and/or drug misuse, at the discretion of the Investigator.

12. Use of any over the counter cold prophylaxis products including nasal sprays, C-vitamins, zinc or Echinacea within 1 month prior to the enrolment.

13. Participation in other clinical trial with medical investigational product within 30 days or 5 drug half-lives (whichever is longer) prior to enrolment.

14. Hypersensitivity/allergy to any of the active or placebo ingredients/ components.

15. Individuals with close contact to at risk patient group, including:

• Infants (less than 6 months);

• The extremely elderly or infirm;

• Pregnant and/or breastfeeding women;

• Patients with immunosuppression (e.g., human immunodeficiency virus (HIV), transplant recipients on anti-rejection medications, those undergoing chemo- or immuno-therapy).

• Other factors that in the opinion of the investigator are considered a risk.