Approval Probability
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ATTO-1310 · 2 trials · 5 indications
Participants achieved a response if their WI-NRS improved 4 or more points from baseline on a scale ranging from zero (no itch) to 10 (worst possible itch). The baseline is calculated as the average in the final week prior to Day 1. The WI-NRS4 response endpoint at Week 12 is calculated as the average of the daily WI-NRS during Week 12 visit relative to the baseline average WI-NRS.
The primary analysis will describe the incidence of AEs and laboratory abnormalities. AEs will be coded according to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA, version 26.1 or the current version). Their severity will be graded using the NCI CTCAE v5.0 or the current version.
Clinical laboratory parameters (hematologic and blood chemistry) will be summarized for each post-baseline visit.
ECG findings (including QT abnormalities) will be summarized for each post-baseline visit.
Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized for each post-baseline visit.
| Arm | Type | Description |
|---|---|---|
| ATTO-1310 Dose A | EXPERIMENTAL | ATTO-1310 high dose induction |
| ATTO-1310 Dose B | EXPERIMENTAL | ATTO-1310 low dose induction |
| Placebo | EXPERIMENTAL | Placebo induction |
| ATTO-1310 Dose C | EXPERIMENTAL | ATTO-1310 high dose high frequency maintenance |
| ATTO-1310 Dose D | EXPERIMENTAL | ATTO-1310 high dose low frequency maintenance |
| ATTO-1310 Dose E | EXPERIMENTAL | ATTO-1310 low dose high frequency maintenance |
| ATTO-1310 dose F | EXPERIMENTAL | ATTO-1310 low dose low frequency maintenance |
| ATTO-1310 single dose IV | EXPERIMENTAL | ATTO-1310 Attobody Dose level cohorts receiving a single dose IV |
| ATTO-1310 Placebo single dose IV | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm with single dose IV |
| ATTO-1310 single dose SC | EXPERIMENTAL | ATTO-1310 Attobody Dose level cohorts receiving a single dose SC |
| ATTO-1310 Placebo single dose SC | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm with single dose SC |
| ATTO-1310 multiple dose SC | EXPERIMENTAL | ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses |
| ATTO-1310 Placebo multiple dose SC | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm administered in multiple SC doses |
| Name | Type | Description |
|---|---|---|
| ATTO-1310 | DRUG | ATTO-1310 |
| Placebo | DRUG | Placebo preparation to match ATTO-1310 dose |
| ATTO-1310 Placebo | DRUG | Placebo preparation to match ATTO-1310 Dose |
Inclusion Criteria: * Aged 18 to 90 years with a body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 40 kg/m\^2. * History of chronic pruritus for at least 6 months that is considered of unknown origin (without a clear association to another condition or medication) as assessed b...
ATTO-1310 is an investigational small molecule being developed by Alamar Biosciences, Inc. for dermatology indications. It is being studied in atopic dermatitis and chronic pruritus of unknown origin. It is not yet approved and remains in clinical development.
ATTO-1310 is being studied for atopic dermatitis, also called atopic eczema, and for chronic pruritus of unknown origin. Both are dermatologic conditions involving itch and skin inflammation. The drug is investigational, so it is not available as a marketed treatment.
ATTO-1310 is being developed by Alamar Biosciences, Inc., which trades under the ticker ALMR. The company is the sponsor of the clinical program studying the drug in atopic dermatitis and chronic pruritus of unknown origin.
ATTO-1310 is in Phase 1 development, with a Phase 2 trial also listed for chronic pruritus of unknown origin. A Phase 1 study in healthy volunteers and patients with atopic dermatitis and chronic pruritus has been completed. The drug is investigational and has not been approved.
ATTO-1310 has been studied in NCT06787586, a completed Phase 1 trial of safety, tolerability and pharmacokinetics in healthy volunteers and patients with atopic dermatitis and chronic pruritus. A Phase 2 trial, NCT07833306, will evaluate efficacy and safety in chronic pruritus of unknown origin and is not yet recruiting.
The ATTO-1310 clinical program has a total planned enrollment of 300 participants. The completed Phase 1 trial NCT06787586 enrolled 108 participants, and the Phase 2 trial NCT07833306 plans to enroll 300 participants with chronic pruritus of unknown origin. The Phase 2 study is randomized, double blind and placebo controlled.