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Also known as Kamada AAT for inhalation
Kamada-AAT · 2 trials · 2 indications
Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an enzyme linked immunosorbent assay (ELISA) specific for the normal form of AAT (piM). Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.
ITT population with baseline and 12 week values. Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an antineutrophil elastase capacity (ANEC) assay. Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.
| Arm | Type | Description |
|---|---|---|
| Kamada-AAT for Inhalation, 80mg | EXPERIMENTAL | Daily inhalation of Kamada-AAT for Inhalation, 80mg |
| Placebo | PLACEBO_COMPARATOR | Placebo administered by inhalation daily |
| Kamada-AAT for Inhalation, 160mg | EXPERIMENTAL | Daily inhalation of Kamada-AAT for Inhalation, 160mg |
| Alpha-1 Antitrypsin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Kamada-AAT for Inhalation, 80mg | DRUG | - |
| Placebo | DRUG | - |
| Kamada-AAT for Inhalation, 160mg | DRUG | - |
| Kamada AAT for inhalation | BIOLOGICAL | Alpha-1 Antitrypsin (AAT) |
Inclusion Criteria: * Male or female patients between 18 and 65 years of age (inclusive). * Able and willing to sign informed consent. * Males, and non-pregnant, non-lactating females whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investiga...
Kamada-AAT for Inhalation is an investigational therapy being studied for alpha-1 antitrypsin deficiency and emphysema. It is delivered by inhalation rather than infusion. It is in Phase 2 clinical development and is not approved for commercial use.
Kamada-AAT for Inhalation is being developed by Kamada Ltd., which trades on the Nasdaq under the ticker KMDA. The company is the sponsor of the clinical program evaluating the inhaled formulation in patients with alpha-1 antitrypsin deficiency and emphysema.
Kamada-AAT for Inhalation is in Phase 2 clinical development. Two completed Phase 2 trials have evaluated the inhaled formulation, one in alpha-1 antitrypsin deficiency and one in alpha-1 antitrypsin deficient patients with emphysema. It is investigational and has not been approved by the FDA.
Kamada-AAT for Inhalation has been studied in two completed Phase 2 trials. NCT01217671 was an international study in alpha-1 antitrypsin deficient patients with emphysema that enrolled 168 participants across Canada and several European countries. NCT02001688 was a Phase 2 safety and efficacy study conducted in the United States that enrolled 36 participants.
Yes. Kamada-AAT for Inhalation, Kamada AAT for inhalation, and Kamada-AAT for Inhalation, 80mg, all refer to the same investigational inhaled alpha-1 antitrypsin product developed by Kamada Ltd. The 80mg designation describes the dose strength of the inhaled formulation used in clinical study.