Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MBX 2109
Canvuparatide · 4 trials · 2 indications
Responder status is defined as a study participant who meets the following composite criteria: * Independence from active vitamin D * Independence from therapeutic doses of calcium (standing elemental calcium dose of ≤ 600 mg/day) * 2 consecutive albumin-adjusted serum calcium results in the normal range (8.3-10.6 mg/dL) (2.07-2.64 mmol/L) * No increase in study drug
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12/Visit 15 * Independence from active vitamin D supplements * Oral elemental calcium doses of ≤600 mg/day * Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
| Arm | Type | Description |
|---|---|---|
| Canvuparatide | ACTIVE_COMPARATOR | Canvuparatide is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of canvuparatide via a manual SC injection. Dosing is once weekly. |
| Placebo | PLACEBO_COMPARATOR | Placebo is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of placebo via a manual SC injection. Dosing is once weekly. |
| 400 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| 200-1600 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Starting dose of 400 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Starting dose of 600 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Starting dose of 800 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Placebo - once-weekly by subcutaneous injection | PLACEBO_COMPARATOR | - |
| Single 900 µg dose of MBX 2109 | EXPERIMENTAL | A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen |
| Name | Type | Description |
|---|---|---|
| Canvuparatide | DRUG | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
| Placebo | OTHER | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
| 400 µg of MBX 2109 once-weekly by subcutaneous injection | DRUG | Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly |
| 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection | DRUG | Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002. The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections. |
| MBX 2109 | DRUG | Supplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL |
Key Inclusion Criteria: 1. Is an adult ≥18 years of age. 2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening. 3. Intact PTH level below the median value of the normal range 4. Minimum requirement for a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ascendis Pharma A/S | ASND | 4 | PHASE3 | Palopegteriparatide |
| AstraZeneca PLC | AZN | 1 | PHASE3 | eneboparatide |
| MBX Biosciences, Inc. | MBX | 2 | PHASE3 | Canvuparatide |
| BridgeBio Pharma, Inc. | BBIO | 1 | PHASE3 | Encaleret |
Canvuparatide is being developed for the treatment of hypoparathyroidism, a condition in which the body produces insufficient parathyroid hormone. It is an investigational therapy and has not been approved by the FDA. The clinical program is focused on adults with hypoparathyroidism, and the drug has received an orphan drug designation from the FDA.
Canvuparatide targets the parathyroid hormone 1 receptor, known as PTH1R. By acting on this receptor, it is designed to mimic the physiological effects of parathyroid hormone, which regulates calcium and phosphate balance. This mechanism is intended to address the hormonal deficiency that characterizes hypoparathyroidism.
Canvuparatide is being developed by MBX Biosciences, Inc., which trades under the ticker MBX. The company is responsible for the clinical development program, including the ongoing Phase 3 trial and the Phase 2 extension study in patients with hypoparathyroidism.
Canvuparatide is in Phase 3 clinical development for hypoparathyroidism. The Phase 3 study is currently recruiting participants, and a Phase 2 extension study is active but no longer recruiting. The drug remains investigational and has not been approved for any indication.
Canvuparatide is being evaluated in two clinical trials. The Phase 3 trial, NCT07699471, is a randomized, double-blind, placebo-controlled study in adults with hypoparathyroidism, recruiting in the United States. The Phase 2 extension study, NCT06531941, is evaluating long-term safety and tolerability in the United States, Argentina, and Turkey.
Yes, Canvuparatide is also known as MBX 2109. The alternative names refer to different dose levels of the same investigational compound, including 400 micrograms and 200 to 1600 micrograms administered once weekly by subcutaneous injection. Both names describe the same drug candidate being developed for hypoparathyroidism.