Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK2245035 Nasal Spray Solution
GSK2245035 · 3 trials · 3 indications
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 4-10 hours post-allergen challenge includes all post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value.
The measurement of body temperature with an automatic thermometer placed in the subject's mouth will be performed by the research unit staff when a subject is in the unit and by the individual when a subject is not in the unit
Spirometry will be performed at screening and Peak Expiratory Flow will be measured at all other planned time points
Hematology, clinical chemistry, urinalysis and additional parameters to be tested
Visual examination of the nose will be done to assess the color of mucosa, degree of turbinate swelling, presence/description of any secretion, presence/absence of infection, post-nasal drip, crusting, signs of bleeding and any other signs of irritancy
Nasal tolerability will be assessed using a Visual analogue scale scoring system. Subjects will be asked to respond to various statements of a questionnaire by placing a small vertical mark on a horizontal line, 10 centimeters in length, with a statement placed at each end of the line. Nasal symptoms of rhinorrhea, blockage, itchiness, soreness or dryness and modification of the sense of taste/smell will be assessed
Blood samples will be collected to measure levels of TLR7-induced soluble biomarkers and/or allergic blood biomarkers, including but not limited to immunoglobulins
During allergen challenge visits, nasal lavage samples will be collected from one nostril only; nasal filters will be inserted in the other nostril and will remain there for 5 minutes
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
The hematology parameters included are platelet count, red blood cell (RBC) count, white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils.
Clinical chemistry parameters included are blood urea nitrogen (BUN), creatinine, glucose, potassium, C-Reactive protein (CRP) potassium, chloride, total carbon dioxide, calcium, total and direct bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), alkaline phosphatase, uric acid, protein and albumin
Urinalysis parameters included are specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal)
A 12 lead electrocardiogram (ECG) will be measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Visual nasal examination will be conducted by a trained physician
Nasal tolerability symptoms itching, discomfort, post-nasal drip, rhinorrhoea, obstruction will be assessed using a Visual analogue score system
| Arm | Type | Description |
|---|---|---|
| GSK2245035 20 ng | EXPERIMENTAL | Participants will receive 20 ng of GSK2245035 Nasal spray solution (1 spray=10 ng GSK2245035 per actuation per nostril) every week for the duration of 8 weeks administered using a metered Valois VP7 pump |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo Nasal spray solution (1 spray per nostril) every week for the duration of 8 weeks administered using a metered Valois VP7 pump |
| GSK2245035 Arm | EXPERIMENTAL | Subjects participating prior to 2014 will receive i.n GSK2245035 80 ng once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in 2014 will receive i.n GSK2245035 20 ng once weekly for 8 weeks (each dose will be split between the two nostrils). |
| Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive i.n placebo once weekly for 8 weeks (each dose will be split between the two nostrils) |
| GSK2245035 - 40 ng or placebo | EXPERIMENTAL | Subjects will receive GSK2245035 - 40 nanogram (ng) or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 80 ng or placebo | EXPERIMENTAL | Subjects will receive GSK2245035 - 80 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 120 ng or placebo | EXPERIMENTAL | Subjects will receive GSK2245035 - 120 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 160 ng or placebo | EXPERIMENTAL | Subjects will receive GSK2245035 - 160 ng or placebo once per week, for four treatment weeks. There will be washout period of 7 days between treatment periods. |
| Name | Type | Description |
|---|---|---|
| GSK2245035 Nasal Spray Solution | DRUG | GSK2245035 Nasal Spray Solution 0.2 microgram (mcg)/mL delivering 10 ng GSK2245035 per actuation. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate. |
| Placebo Nasal Spray Solution | DRUG | Nasal Spray Solution as for GSK2245035 without active ingredient. |
| GSK2245035 | DRUG | Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks |
| Placebo | DRUG | Nasal Spray Solution, to be given intranasal, once weekly for 8 weeks |
| Type 1 amber glass bottle | DEVICE | fitted with a metered Valios VP7 pump |
Inclusion Criteria * Between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Diagnosis of asthma, as defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with var...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
GSK2245035 is an investigational small molecule developed by GSK plc for respiratory conditions, including asthma, asthma and rhinitis, and mild asthma with allergic rhinitis. It is formulated as a nasal spray solution and is designed to act on the immune system through the Toll-like receptor 7 pathway. It remains in clinical development.
GSK2245035 is being studied for asthma, including mild asthma and allergic rhinitis, as well as asthma with rhinitis. It is an investigational nasal spray, not an approved therapy, and its use in these conditions remains under clinical evaluation. No approved indication has been established.
GSK2245035 targets Toll-like receptor 7, or TLR7, and acts as an agonist at this receptor. TLR7 is part of the innate immune sensing system. By activating TLR7, the drug is intended to modulate immune responses relevant to allergic airway conditions such as asthma and rhinitis.
GSK2245035 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the drug in respiratory allergy and asthma indications. The compound is an investigational asset within GSK's respiratory pipeline.
GSK2245035 is in Phase 2 development. It is an investigational drug and has not been approved for any indication. The completed Phase 2 studies evaluated its safety, pharmacodynamics, and effects on allergic reactivity in participants with respiratory allergies and asthma.
GSK2245035 has been studied in completed Phase 2 trials, including NCT02833974 in asthma, NCT01788813 in mild asthma and allergic rhinitis, and NCT01607372 in asthma and rhinitis. These trials enrolled adults and assessed safety, pharmacodynamics, and allergen-induced responses. No active trials are currently listed.
Yes, GSK2245035 Nasal Spray Solution is another name for GSK2245035. It refers to the same investigational compound administered intranasally. The nasal spray formulation was used in the Phase 2 studies evaluating the drug in asthma and allergic rhinitis.