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Also known as IXP, VX-147
Inaxaplin · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| IXP (Inaxaplin) | EXPERIMENTAL | Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks. |
| Part A (Phase 2/3): VX-147 | EXPERIMENTAL | Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks. |
| Part A (Phase 2/3): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to VX-147. |
| Part B (Phase 3): VX-147 | EXPERIMENTAL | Participants who complete Part A will receive VX-147 for an additional 96 weeks. |
| VX-147 | EXPERIMENTAL | All participants received VX-147 at a dosage of 15 mg once daily (qd) for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately greater than or equal to (≥) 3 g/g (± 10%) and less than (\<) 10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2. |
| Sequence A: VX-147 | EXPERIMENTAL | Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Sequence B: VX-147 | EXPERIMENTAL | Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Sequence C: VX-147 | EXPERIMENTAL | Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Name | Type | Description |
|---|---|---|
| Inaxaplin | DRUG | Tablets for Oral Administration. |
| VX-147 | DRUG | Tablets for oral administration. |
| Placebo | DRUG | Tablets for oral administration. |
Key Inclusion Criteria: * Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay * Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m\^2 at screening Key Exc...
Inaxaplin is an investigational small molecule being developed for the treatment of proteinuric kidney disease, a condition characterized by excess protein in the urine. It is being studied in patients with proteinuric APOL1 mediated kidney disease, with or without comorbidities. The drug is currently in Phase 2 clinical development.
Inaxaplin is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting clinical research to evaluate the safety and efficacy of Inaxaplin in patients with proteinuric kidney disease.
Inaxaplin is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for the treatment of proteinuric kidney disease, specifically in patients with APOL1 mediated kidney disease.
Inaxaplin has been studied in one clinical trial with the identifier NCT06794996. This Phase 2 trial, titled 'Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities,' was completed in the United States. The trial enrolled 42 adult participants of all sexes and was uncontrolled, meaning there was no comparator group.
Inaxaplin is the sole name provided for this investigational drug. There are no alternative names listed for Inaxaplin in the available information. It is a small molecule being developed by Vertex Pharmaceuticals for the treatment of proteinuric kidney disease.