Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral Encochleated Amphotericin B (CAMB), Amphotericin B, CAMB, MAT2203
Encochleated 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 ...
Encochleated amphotericin B is an oral small molecule antifungal being developed by Matinas Biopharma Holdings, Inc. (ticker MTNB). It is also known as oral encochleated amphotericin B, or CAMB. It is under development for vulvovaginitis, including vulvovaginal candidiasis, in the infectious disease therapeutic area.
Encochleated amphotericin B is being developed for vulvovaginitis, specifically vulvovaginal candidiasis, a vaginal yeast infection. The clinical program has studied it in adult women aged 18 years and older in the United States. It is an investigational therapy and has not been established as a marketed treatment.
Encochleated amphotericin B is being developed by Matinas Biopharma Holdings, Inc., which trades under the ticker MTNB. The company is the sponsor of the clinical program for the oral formulation, also referred to as CAMB or MAT2203.
Encochleated amphotericin B is in Phase 2 development. Its single clinical trial, NCT02971007, was a Phase 2 study that has been completed. The drug remains investigational and is not approved for commercial use.
Encochleated amphotericin B has been studied in one clinical trial, NCT02971007, titled Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC). The Phase 2 trial enrolled 137 participants, was randomized and active controlled, and has been completed.
Yes. Encochleated amphotericin B is also known as oral encochleated amphotericin B, or CAMB, and is referred to as MAT2203 in its clinical program. These names describe the same oral antifungal candidate developed by Matinas Biopharma Holdings, Inc. for vulvovaginal candidiasis.