| PIPELINES | TARGET INDICATION |
AREA | PRE- CLINICAL |
CLINIAL STUDY | NDA | APPROVAL /LAUNCH |
PROGRESS | PARTNER | ||
|---|---|---|---|---|---|---|---|---|---|---|
| PHASE 1 | PHASE 2 | PHASE 3 | ||||||||
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SP-05 |
Colorectal Cancer (CRC) | Japan |
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Decision to resume development. | ー |
SP-05
In August 2020, Solasia acquired the rights to SP-05 (arfolitixorin) from Isofol Medical AB for Japan.
SP-05 is a product pipeline for an increase in the antitumor efficacy of fluorouracil.
Isofol executed several clinical studies in Europe, and the results from a phase II study indicate that SP-05 has a potential to increases the antitumor effect of fluorouracil in patients with advanced colorectal cancer.
Development Status： Clinical study planning
In December 2018, a global phase III study has been initiated by Isofol in the U.S., Canada, Europe, Australia and Japan.
Nov. 2022 Phase III clinical trials are completed; primary endpoints not met; development suspended.
March 2024: Decision to resume development.
Expected Target Indications
Increase in the antitumor efficacy of fluorouracil
Arfolitixorin is a new drug candidate being developed to treat colorectal cancer (CRC). Other potential indication of arfolitixorin in combination with fluorouracil is including the treatment for pancreatic cancer, breast cancer, stomach cancer, and head and neck cancers.
The combination use of DNA synthesis inhibitor, fluorouracil (5-FU), and folate-based prodrugs, leucovorin (LV) and levoleucovorin (l-LV), is standard of care chemotherapy for advanced colorectal cancer, and folate analogs are used to increase the antitumor effect of fluorouracil (5-FU).
Unlike leucovorin (LV) and levoleucovorin (l-LV); which must be metabolized into MTHF ([6R]-5, 10-methylenetetrahydrofolate) in the body in order to be effective in the treatment of cancer, the active substance in arfolitixorin is MTHF. This means that no metabolic activation is required and arfolitixorin consequently has the potential to achieve a more powerful antitumor effect for all patients in combination with fluorouracil (5-FU) treatment.