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Kamada-AAT for · 1 trial · 1 indication
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 |
| Name | Type | Description |
|---|---|---|
| Kamada-AAT for Inhalation, 80mg | DRUG | - |
| Placebo | DRUG | - |
| Kamada-AAT for Inhalation, 160mg | DRUG | - |
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 is an inhaled, human, alpha-1 antitrypsin (AAT) therapy in Phase 2 clinical development for the treatment of Alpha-1 Antitrypsin Deficiency and emphysema. It is being developed by Kamada Ltd. (KMDA) as a respiratory therapeutic. The drug is administered via inhalation to deliver AAT directly to the lungs.
Kamada AAT for is a monoclonal antibody that targets alpha-1 antitrypsin deficiency, a genetic condition that leads to low levels of the AAT protein, which protects the lungs from damage. By delivering inhaled human AAT, the therapy aims to supplement the deficient protein and potentially slow the progression of emphysema associated with the condition.
Kamada AAT for is developed by Kamada Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KMDA. The company specializes in plasma-derived therapies and is conducting clinical trials to evaluate the safety and efficacy of this inhaled AAT product for patients with Alpha-1 Antitrypsin Deficiency and emphysema.
Kamada AAT for is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, with a total enrollment of 204 patients across studies in multiple countries, including the United States, Canada, and several European nations.
Kamada AAT for has been studied in two completed Phase 2 clinical trials. The first, NCT01217671, enrolled 168 patients with emphysema across Canada, Denmark, Germany, Ireland, Netherlands, Sweden, and the United Kingdom. The second, NCT02001688, enrolled 36 patients with Alpha-1 Antitrypsin Deficiency in the United States. Both trials were randomized, double-blind, and placebo-controlled.
Yes, Kamada AAT for is the same drug as Kamada-alpha-1-antitrypsin (AAT) for inhalation. The clinical trial NCT02001688 refers to the drug as Kamada-alpha-1-antitrypsin (AAT) for inhalation, while the product is commonly known as Kamada AAT for. Both names refer to the same inhaled human AAT therapy under development by Kamada Ltd.