Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CD101 · 3 trials · 6 indications
Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
Number of subjects with clinically significant adverse events (AEs)
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
| Group 3 | ACTIVE_COMPARATOR | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. |
| Group 2 | EXPERIMENTAL | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
| CD101 IV | EXPERIMENTAL | multiple ascending dose intravenous infusion |
| Placebo | PLACEBO_COMPARATOR | normal saline |
| Name | Type | Description |
|---|---|---|
| CD101 | DRUG | Intravenous antifungal therapy |
| Caspofungin | DRUG | Intravenous antifungal therapy |
| Fluconazole | DRUG | oral antifungal therapy |
| intravenous placebo | DRUG | normal saline |
| oral placebo | DRUG | microcrystalline cellulose |
| CD101 IV | DRUG | antifungal |
| Placebo | DRUG | Normal saline |
Inclusion Criteria: * mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or posi...
CD101 is an investigational small molecule being developed for the treatment of candidemia and invasive candidiasis, as well as for use in healthy subjects in early-phase studies. It is being studied in infectious disease, specifically for fungal infections such as candidemia and fungemia.
CD101 is a small molecule antifungal agent. It is being studied for its activity against Candida species that cause candidemia and invasive candidiasis. The specific molecular target has not been disclosed in the available information.
CD101 is being developed by Cidara Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CDTX on the NASDAQ exchange.
CD101 is currently in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, with no active trials ongoing. The most advanced study is a Phase 2 trial comparing CD101 to caspofungin in patients with candidemia and/or invasive candidiasis.
CD101 has completed three clinical trials. Two Phase 1 studies (NCT02516904 and NCT02551549) evaluated single and multiple ascending doses in healthy subjects. A Phase 2 study (NCT02734862) compared CD101 to caspofungin in patients with candidemia and/or invasive candidiasis, with a total enrollment of 207 participants.
CD101 is also known as rezafungin. It is an investigational antifungal drug being developed by Cidara Therapeutics. The name CD101 is used in clinical trial registrations, while rezafungin is the international nonproprietary name for the compound.