Komori
Other Disclosures4597Solasia Pharma K.K.Pharmaceuticals

Latest Information on the Phase Ib/II Clinical Trial of Our Drug Candidate SP-05 (Alfolitixorin Sulfate)

In the Phase Ib/II trial of SP-05, evaluation of the third dose level, 300 mg/m², has been completed. Following approval by the Safety Evaluation Committee, dosing and patient enrollment have begun for the final cohort at 500 mg/m². The Phase II portion is planned to begin in the second half of 2026.

Worth reading
58In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
500
mg/m² (final dose level)
Wording
Conditional
How definitive the wording is.

Announced details

SP-05 (Arfolitixorin Sulfate)
Applicable field (uses covered by this announcement)

Treatment of metastatic colorectal cancer. Improving the efficacy of existing cancer treatments.

Launch dateSecond half of 2026 (planned start of the Phase II portion)
What the company reported numerically
Quantitative Effects

No dose-limiting toxicity was observed in the evaluation of the third dose level, 300 mg/m².

Usage history

3 dose cohorts have been completed through the third dose level.

Relationship between the counterparty and the company
Solasia Pharma K.K.4597
Relationship with the Company

Isofol is the source of the in-licensed rights to SP-05 and a development partner.

CounterpartyIsofol Medical AB

Headquartered in Gothenburg, Sweden, the company is a clinical-stage company developing arfolitixorin. Other attributes: Not disclosed.

Location (as indicated in this announcement)

Charité – Universitätsmedizin Berlin, Germany

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

World Health Organization (WHO)

Announced details
ItemDetails
Names of Products / Services CoveredSP-05 (Arfolitixorin Sulfate)
CounterpartyIsofol Medical AB
Counterparty overviewHeadquartered in Gothenburg, Sweden, the company is a clinical-stage company developing arfolitixorin. Other attributes: Not disclosed.
Relationship with the CompanyIsofol is the source of the in-licensed rights to SP-05 and a development partner.
Launch dateSecond half of 2026 (planned start of the Phase II portion)
Applicable areaTreatment of metastatic colorectal cancer. Improving the efficacy of existing cancer treatments.
LocationCharité – Universitätsmedizin Berlin, Germany
Quantitative EffectsNo dose-limiting toxicity was observed in the evaluation of the third dose level, 300 mg/m².
Usage history3 dose cohorts have been completed through the third dose level.
SourceWorld Health Organization (WHO)
Items this document does not state (8)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The company decided to set 500 mg/m² as the final dose level based on the recommendation of the Safety Evaluation Committee and the favorable results obtained from the 3 dose cohorts conducted to date.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Latest Information on the Phase Ib/II Clinical Trial of Our Drug Candidate SP-05 (Alfolitixorin Sulfate) | Solasia Pharma K.K. (4597) timely disclosure | Komori