Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR447537 · 2 trials · 2 indications
Incidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions).
To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity \[ANEC\] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in participants treated with SAR447537 compared to A1PI
| Arm | Type | Description |
|---|---|---|
| SAR447537 (INBRX-101) | EXPERIMENTAL | A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection |
| SAR447537 (INBRX-101) Q3W | EXPERIMENTAL | IV every 3-weeks (Q3W) and placebo (normal saline) |
| SAR447537 (INBRX-101) Q4W | EXPERIMENTAL | IV every 4-weeks (Q4W) and placebo (normal saline) |
| Zemaira (A1PI) | ACTIVE_COMPARATOR | 60 mg/kg IV once weekly (QW) and placebo (normal saline) |
| Name | Type | Description |
|---|---|---|
| SAR447537 | DRUG | A1PI, Recombinant, Bivalent Fc Fusion Protein |
| Zemaira | DRUG | Alpha1-Proteinase Inhibitor (Human) |
Inclusion Criteria: 1. Males or females 18-80 years of age, inclusive, at the time of screening 2. Diagnosis of AATD 3. Evidence of emphysema secondary to AATD 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7 5. Current non-smoking status Exclusion Criteria: For newly...
SAR447537 is an investigational small molecule being developed for Alpha 1-Antitrypsin Deficiency, specifically for the treatment of emphysema associated with this condition. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
SAR447537 targets AAT, which is the alpha-1 antitrypsin protein. By targeting this protein, the drug aims to address the underlying deficiency in patients with Alpha 1-Antitrypsin Deficiency and associated emphysema.
SAR447537 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for the treatment of Alpha 1-Antitrypsin Deficiency with emphysema.
SAR447537 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied in two Phase 2 trials, one of which has been completed and another that is active but not recruiting participants.
SAR447537 is being studied in two Phase 2 clinical trials. The first, NCT05856331, compared SAR447537 to plasma-derived A1PI therapy in adults with AATD emphysema and has been completed. The second, NCT05897424, is a long-term, open-label study in adults with the same condition and is active but not recruiting.
Yes, SAR447537 is also known as INBRX-101. Clinical trials for this drug use both names, with the completed study NCT05856331 and the ongoing study NCT05897424 referring to the drug as SAR447537 (INBRX-101).