Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Protollin · 1 trial · 1 indication
Safety and tolerability of ascending doses of nasal Protollin following administration of two doses one week apart in subjects, 60-85 years inclusive with Early Symptomatic Alzheimer's Disease (29-20 MMSE classification). Safety will be assessed by physical examination (including evaluation of the nose and oropharynx), laboratory studies, EKG, and elicited and spontaneously reported signs and symptoms, using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) for the evaluation of toxicities and reactogenicity. Tolerability will be assessed by the degree of severity of both spontaneously reported and elicited symptoms and associated signs, systemically and at the site of administration following administration of nasal Protollin, if thought by the investigator to be related or possibly related to its administration.
| Arm | Type | Description |
|---|---|---|
| Cohort A | ACTIVE_COMPARATOR | Protollin 0.1 mg or placebo |
| Cohort B | ACTIVE_COMPARATOR | Protollin 0.5 mg or placebo |
| Cohort C | ACTIVE_COMPARATOR | Protollin 1.0 mg or placebo |
| Cohort D | ACTIVE_COMPARATOR | Protollin 1.5 mg or placebo |
| Name | Type | Description |
|---|---|---|
| Protollin | DRUG | For the 0.1, 0.5, and 1.0 mg dose groups, Protollin (450 μL per vial) in an aqueous buffer will be administered in two, 0.1 μL sprays, one per nostril. For the 1.5 mg dose group, Protollin (450 muL per vial) in an aqueous buffer will be administered in three, 0.1 μL sprays, two in one nostril and one in the other nostril. |
Inclusion Criteria: 1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines1 for Early Symptomatic Alzheimer's Disease and have a MMSE of 29-20. 2. Age between 60-85 years (inclusive). 3. Good general health with no disease expected to interfere with the study. 4. On a stable m...
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Protollin is being developed for Alzheimer disease. It is an investigational therapy studied in early symptomatic Alzheimer disease, a stage where patients show mild cognitive symptoms. NovaBridge Biosciences is evaluating it in a Phase 1 clinical program, and it has not been approved for any indication.
Protollin is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company is responsible for the clinical development of the asset, including the completed Phase 1 trial in early symptomatic Alzheimer disease conducted in the United States.
Protollin is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials listed. The program has studied 16 participants to date in a randomized, double-blind, active-controlled design.
Protollin has been studied in one completed Phase 1 trial, NCT07187141, titled Nasal Protollin in Early Symptomatic Alzheimer's Disease. The trial enrolled 16 participants aged 60 years and older in the United States and used a randomized, double-blind, active-controlled design.
No, Protollin is not approved. It is an investigational product still in clinical development, with only a completed Phase 1 trial in early symptomatic Alzheimer disease. Approval would require further clinical testing beyond the Phase 1 stage.