Komori
Other Disclosures206APRISM BioLab Co.,LTDPharmaceuticals

Notice Regarding the Progress of the Phase II Clinical Trial of PRI-724 in Patients with Cirrhosis

In the Phase II trial of PRI-724 in patients with MASH-related decompensated cirrhosis, the PRI-724 group did not significantly improve the primary endpoint, the Child-Pugh score, compared with the placebo group. The separate cohort comprising patients with cirrhosis caused by hepatitis B or C virus infection will continue.

Worth reading
65In focus
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Direction
Mixed performance
Direction inferred from the company’s description.
Scale
35
Example
Wording
Conditional
How definitive the wording is.

Announced details

PRI-724 (generic name: hosencivint; Ohara Pharmaceutical compound code: OP-724)
Applicable field (uses covered by this announcement)

Decompensated cirrhosis (caused by hepatitis C or B virus infection or MASH)

Contract DateMay 2018
What the company reported numerically
Quantitative Effects

No significant improvement was observed in the Child-Pugh score, the primary endpoint, in Cohort B

Usage history

35 patients enrolled in Cohort B (dosing twice weekly for 24 weeks)

Relationship between the counterparty and the company
PRISM BioLab Co.,LTD206A
Relationship with the Company

In May 2018, the parties entered into a license-out agreement for PRI-724 in fields other than cancer. 大原薬品工業株式会社 is conducting the Phase II clinical trial, while the Company is supporting its development.

Counterparty大原薬品工業株式会社

Head office: Chuo-ku, Tokyo; Representative Director, President and CEO: Ohara Seiji (大原誠司). Other details: Not disclosed.

Impact on Business Performance

This matter will have no impact on the Company's results.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredPRI-724 (generic name: hosencivint; Ohara Pharmaceutical compound code: OP-724)
Counterparty大原薬品工業株式会社
Counterparty overviewHead office: Chuo-ku, Tokyo; Representative Director, President and CEO: Ohara Seiji (大原誠司). Other details: Not disclosed.
Relationship with the CompanyIn May 2018, the parties entered into a license-out agreement for PRI-724 in fields other than cancer. 大原薬品工業株式会社 is conducting the Phase II clinical trial, while the Company is supporting its development.
Contract DateMay 2018
Applicable areaDecompensated cirrhosis (caused by hepatitis C or B virus infection or MASH)
Quantitative EffectsNo significant improvement was observed in the Child-Pugh score, the primary endpoint, in Cohort B
Usage history35 patients enrolled in Cohort B (dosing twice weekly for 24 weeks)
Impact on Business PerformanceThis matter will have no impact on the Company's results.
Items this document does not state (9)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleSource

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 explains that Cohort B is an exploratory study evaluating the potential utility of PRI-724 in patients with MASH-related decompensated cirrhosis, and that these results alone do not directly rule out the development potential of ongoing Cohort A or PRI-724 as a whole.

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Notice Regarding the Progress of the Phase II Clinical Trial of PRI-724 in Patients with Cirrhosis | PRISM BioLab Co.,LTD (206A) timely disclosure | Komori