Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MBX 2109 (Part A), Canvuparatide
MBX 2109 · 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 |
| MBX Biosciences, Inc. | MBX | 2 | PHASE3 | Canvuparatide |
| AstraZeneca PLC | AZN | 1 | PHASE3 | eneboparatide |
| BridgeBio Pharma, Inc. | BBIO | 1 | PHASE3 | Encaleret |
MBX 2109 is an investigational small molecule being developed by MBX Biosciences, Inc. for endocrine conditions. It is under study in hypoparathyroidism and in renal impairment. Development has reached Phase 2, and the program includes a completed Phase 2 trial in hypoparathyroidism and a completed Phase 1 study in renal impairment.
MBX 2109 is being studied for the treatment of hypoparathyroidism, a condition in which the parathyroid glands do not produce enough parathyroid hormone. It has also been evaluated in adults with renal impairment. These uses are investigational, and the drug has not been established as an approved therapy for either condition.
MBX 2109 is developed by MBX Biosciences, Inc., which trades under the ticker MBX. The company is the sponsor of the clinical program for the drug, including the completed Phase 2 trial in hypoparathyroidism and the completed Phase 1 trial in renal impairment.
MBX 2109 is in Phase 2 development. A completed Phase 2 trial evaluated its safety, pharmacokinetics and efficacy in patients with hypoparathyroidism, and a completed Phase 1 study evaluated its safety and pharmacokinetics in adults with normal and impaired renal function. It is an investigational drug and is not approved.
MBX 2109 has been studied in two completed trials. NCT06465108 was a Phase 2 trial of safety, pharmacokinetics and efficacy in 64 patients with hypoparathyroidism across the United States, Argentina and Turkey. NCT06496217 was a Phase 1 safety and pharmacokinetics study in 25 adults with normal and impaired renal function in the United States.
Yes. MBX 2109 is also referred to as MBX 2109 (Part A), so searches using either name refer to the same investigational small molecule from MBX Biosciences, Inc. The parenthetical label distinguishes a portion of the clinical program rather than a separate drug asset.