Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Encochleated Amphotericin B, CAMB, MAT2203
Amphotericin B · 3 trials · 6 indications
Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
Proportion of cAMB daily dose received and tolerated without vomiting within 30 minutes.
CSF early fungicidal activity (EFA) during 2-week induction therapy
| Arm | Type | Description |
|---|---|---|
| CAMB 200 mg | EXPERIMENTAL | 200 mg CAMB (MAT2203) Oral Amphotericin B |
| CAMB 400 mg | EXPERIMENTAL | 400 mg CAMB (MAT2203) Oral Amphotericin B |
| Fluconazole 150 mg | ACTIVE_COMPARATOR | Fluconazole Diflucan |
| CAMB (Encochleated Amphotericin B) | EXPERIMENTAL | Encochleated Amphotericin B (200 mg, 400 mg, 800 mg) |
| Phase 1a single ascending dose study | EXPERIMENTAL | Phase IA will consist of a single ascending dose study in 9 participants to test three doses to determine the max tolerated dose. |
| Phase 1b multiple day dosing | EXPERIMENTAL | 9 subjects will receive the Phase Ia 100% tolerated MAT2203 dose for 7 days. |
| Phase 2 safety and tolerability | EXPERIMENTAL | Safety, tolerability, and microbiologic efficacy of MAT2203 among HIV-infected patients with cryptococcal meningitis compared with standard IV AMB. |
| Name | Type | Description |
|---|---|---|
| Oral Encochleated Amphotericin B (CAMB) | DRUG | lipid-crystal nano-particle formulation amphotericin B |
| Fluconazole | DRUG | - |
| Amphotericin B | DRUG | Oral lipid nanocrystal formulation of amphotericin B |
| MAT2203 | DRUG | Encochleated amphotericin B |
Key Inclusion Criteria: Informed consent Clinical diagnosis of moderate to severe VVC Negative pregnancy test Vaginal pH less than 4.5 Key Exclusion Criteria: Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs Receiving antifungal therapy ...
Amphotericin B is being studied for the treatment of Chronic Mucocutaneous Candidiasis, a persistent fungal infection. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated for its ability to address this condition, though it is not yet approved for this use.
Amphotericin B is being developed by Matinas Biopharma Holdings, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol MTNB. The company is conducting clinical research on this drug for the treatment of Chronic Mucocutaneous Candidiasis.
Amphotericin B is in Phase 2 clinical development for Chronic Mucocutaneous Candidiasis. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 study has been completed, and the drug remains under evaluation for this indication.
Amphotericin B has one completed Phase 2 clinical trial registered as NCT02629419, titled "CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis." The study enrolled 4 participants in the United States and was an uncontrolled, non-randomized trial. No active trials are currently listed for this drug.
Amphotericin B is also known as MAT2203, as indicated by the clinical trial title. The Phase 2 study NCT02629419 refers to the drug as CAMB/MAT2203, confirming that MAT2203 is an alternative name for Amphotericin B in this development program.