Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGE-1 · 1 trial · 1 indication
Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above).
Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: \>2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to \[\>=\] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.
| Arm | Type | Description |
|---|---|---|
| PF-06444753 | EXPERIMENTAL | - |
| PF-06444752 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Intramuscular |
| Name | Type | Description |
|---|---|---|
| IGE-1 | BIOLOGICAL | Intramuscular, multiple dose |
| IGE-2 | BIOLOGICAL | Intramuscular, multiple dose |
| Saline | BIOLOGICAL | Saline (0.9% sodium chloride) |
Inclusion Criteria: * Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive, * Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
IGE-1 is an investigational monoclonal antibody being developed for the treatment of allergic rhinitis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety and tolerability in subjects with allergic rhinitis.
IGE-1 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for allergic rhinitis, a condition involving an immune response to allergens, but the exact mechanism of action has not been publicly detailed.
IGE-1 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of allergic rhinitis.
IGE-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for allergic rhinitis.
IGE-1 has been studied in one completed Phase 1 clinical trial with the identifier NCT01723254. This trial assessed the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis. The study enrolled 190 participants in Canada and was randomized, double-blind, and placebo-controlled.
IGE-1 is associated with the investigational compounds PF-06444753 and PF-06444752, which were evaluated in the Phase 1 clinical trial NCT01723254 for allergic rhinitis. The relationship between these names and IGE-1 is not fully detailed in available information, but they appear to be related to the same development program.