Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LXE408 · 3 trials · 3 indications
Cure at Day 180 (D180) is defined as: * 100% re-epithelialization of ulcerated lesions (if any) or flattening and/or no signs of induration of non-ulcerated lesions (if any) up to and at D90 and, * no relapse by D180, and * no rescue therapy up to D180 * no death, regardless of cause, up to D180
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Initial cure defined as clinical improvement of Visceral leishmaniasis (VL), absence of parasites in the spleen or bone marrow (microscopy), and no rescue therapy on or before Day 28.
| Arm | Type | Description |
|---|---|---|
| LXE408 BID for 14 days | EXPERIMENTAL | LXE408 BID for 14 days followed by placebo BID for 14 days. |
| LXE408 BID for 28 days | EXPERIMENTAL | - |
| Miltefosine 50 mg PO TID for 28 days | ACTIVE_COMPARATOR | - |
| LXE408 28 days | EXPERIMENTAL | LXE408 administered by oral route |
| LXE408 14 days and Placebo 14 days | EXPERIMENTAL | LXE408 administered by oral route, followed by Placebo administered by oral route |
| Placebo 28 days | PLACEBO_COMPARATOR | Placebo administered by oral route |
| Benznidazole 60 days | ACTIVE_COMPARATOR | Benznidazole administered by oral route |
| LXE408 short regimen | EXPERIMENTAL | LXE408 once daily for seven days (followed by 7 days of placebo). |
| LXE408 long regimen | EXPERIMENTAL | LXE408 once daily for 14 days |
| Standard of care | ACTIVE_COMPARATOR | AmBisome® 10 mg/kg IV single dose (SDA) |
| Name | Type | Description |
|---|---|---|
| LXE408 | DRUG | LXE408 film-coated tablets. |
| Miltefosine 50 MG Oral Capsule [Impavido] | DRUG | Each capsule contains 50 mg miltefosine in an opaque, red, hard gelatin capsule. Capsules are supplied in packs of 56 capsules sealed in 8 aluminum blister stripes, each containing 7 capsules. |
| Placebo to LXE408 | DRUG | Film-coated tablets. |
| Placebo | DRUG | Placebo administered by oral route |
| Benznidazole | DRUG | Benznidazole administered by oral route (administered as standard of care) |
| AmBisome® | DRUG | Sterile lyophilised powder in a 15 mL sterile clear glass vial |
Inclusion Criteria: 1. Participant must be aged ≥18 years old and weighing \> 50kg 2. Participant with first episode of CL fulfilling the following characteristics: * ≤ 6 lesions * At least one lesion of \> 50 mm2 of area * a history of CL of no longer than 6 months 3. a diagnosis of CL c...
LXE408 is an investigational small molecule being developed for three infectious diseases: Chagas disease, localized cutaneous leishmaniasis, and primary visceral leishmaniasis. It is currently in Phase 2 clinical development and is not approved by the FDA.
LXE408 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting multiple Phase 2 trials of the drug across different countries.
LXE408 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. There are three Phase 2 trials listed for the drug, with one completed, one recruiting, and one not yet recruiting.
LXE408 has three Phase 2 trials. NCT05593666 is a completed study in primary visceral leishmaniasis in India. NCT06632600 is recruiting for chronic Chagas disease in the US, Argentina, Brazil, and Colombia. NCT06997159 is not yet recruiting for localized cutaneous leishmaniasis in Brazil and Panama.
LXE408 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its efficacy and safety in treating parasitic infections including Chagas disease and leishmaniasis.
No, LXE408 is not the same as miltefosine. In one clinical trial, miltefosine is used as an active control to compare the efficacy and safety of two LXE408 oral regimens in participants with localized cutaneous leishmaniasis.