Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model

NCT05507567 | Completed Phase 2 Results

• 1 other identifier: PNG-NMF-201
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants

Conditions

Influenza Viral Infections

Keywords

Influenza; Human Challenge; Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Incidence of Symptomatic Influenza Infection

  Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point. Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).

  Day 1 to Day 8

• Severity of Symptoms

  Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.

  Day 1 to Day 8

Secondary Outcomes (7)

• Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)

  Day 1 to Day 8

• Viral Shedding Over Time

  Day 1 (pm) to Day 8 (am)

• Viral Shedding Over Time

  Day 1 (pm) to Day 8 (am)

• Weight of Nasal Discharge

  Day 1 (am) to Day 8 (am)

• Nasal Discharge

  Day 1 (am) to Day 8 (am)

Study Arms (3)

Neumifil multiple dose prophylactic treatment

EXPERIMENTAL

Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge

Drug: Neumifil

Neumifil single dose prophylactic treatment

EXPERIMENTAL

Neumifil intranasal spray administered as a single dose and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge

Drug: Neumifil; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Intranasal spray administered as 3 single daily doses prior to viral challenge

Drug: Placebo

Interventions

Neumifil DRUG

Liquid for intranasal spray administration

Neumifil multiple dose prophylactic treatment; Neumifil single dose prophylactic treatment

Placebo DRUG

Liquid for intranasal spray administration

Neumifil single dose prophylactic treatment; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent signed and dated by the participant and the investigator obtained before any assessment is performed.
• Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
• A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
• In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.
• Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
• Agree to use highly effective contraception
• Serosuitable for the challenge virus

You may not qualify if:

• History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT, LRT) infection within 4 weeks prior to the first study visit.
• Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the investigator, may interfere with a participant completing the study and necessary investigations. Includes a history of depression or anxiety.
• Any participants who have smoked ≥ 10 pack years at any time.
• Females who are pregnant or breastfeeding
• Any history of anaphylaxis or history of severe allergic reactions to any foods, drugs, insect bites or stings or any known allergy to tetracycline antibiotics.
• Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
• a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge b) Any evidence of nasal inflammation or nasal polyps within the last month c) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalised due to epistaxis on any previous occasion.
• d) Any nasal or sinus surgery within 3 months of the first study visit. Prior or Concomitant Medications and Assessments
• a) Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP.
• b) Intention to receive any vaccination(s) before the last day of follow-up (with the exception of vaccinations recommended for COVID19 as defined by Medicines and Healthcare Regulatory Agency (MHRA)/government vaccination guidelines). No travel restrictions apply after the Day 28 (±3 days) follow-up visit.
• c) Receipt of influenza vaccine (or another IMP relating to treatment of influenza) in the last 6 months prior to the planned date of viral challenge OR a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 2 months prior to screening.
• Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of first dosing with IMP or planned during the 3 months after the final follow-up visit.
• a) Receipt of any investigational drug within 3 months (or 5 half-lives of the IMP used in the other study, whichever is greater), prior to the planned date of first dosing with IMP.
• b) Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP.
• c) Prior inoculation with a virus from the same virus-family as the challenge virus.

Sponsors & Collaborators

• Pneumagen Ltd.: lead

Study Sites (1)

hVIVO Services Limited

London, E1 2AX, United Kingdom

Location

Related Publications (1)

• Kitson G, Byford M, Cass L, Howat D, Kohn B, Bisquera A, Catchpole A, Noulin N, Thomson D. A Phase II, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of HEX17, a Novel Broad-Spectrum Antiviral Drug, in a Controlled Human Infection Model of Influenza Challenge. Infect Dis Ther. 2025 Aug;14(8):1697-1714. doi: 10.1007/s40121-025-01179-2. Epub 2025 Jul 2.

  PMID: 40593264 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: CEO
• Organization: Pneumagen Ltd

douglas.thomson@pneumagen.com

+44 7748357352

Study Officials

• Geoff Kitson

  gkitson@propharmapartners.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled study

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: August 12, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Locations

GB (1)