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Other Disclosures4586Medrx Co.,Ltd.Pharmaceuticals

Preliminary Results from the Alto-101 Phase 2 Clinical Trial

Preliminary results were obtained from the Phase 2 proof-of-concept (POC) clinical trial of Alto-101 in patients with schizophrenia. The primary endpoint did not reach statistical significance, so Alto, the joint development partner, will not pursue development in-house. We have moved to the stage of discussing and deciding on the future strategy, including formulation improvements.

Worth reading
70In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Mixed performance
Direction inferred from the company’s description.
Scale
0.052
p-value (theta-band measure for the primary endpoint)
Wording
Avoiding a definitive answer
How definitive the wording is.

Announced details

Alto-101 (schizophrenia treatment, PDE4 inhibitor transdermal patch)
Applicable field (uses covered by this announcement)

Treatment of patients with schizophrenia and treatment related to cognitive function

What the company reported numerically
Quantitative Effects

Primary endpoint theta-band measure: n=83, d=0.34, p=0.052. Subgroup with impaired cognitive function: n=59, d=0.44, p=0.03.

Relationship between the counterparty and the company
Medrx Co.,Ltd.4586
Relationship with the Company

Alto-101 is being developed in partnership with Alto. We will discuss the detailed analysis of the trial results, including the possibility of improving the formulation.

CounterpartyAlto Neuroscience, Inc. (listed on a New York securities market)

A U.S. drug discovery biotech company based in Los Altos, California.

Impact on Business Performance

The impact on results for the current fiscal year will be minor.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredAlto-101 (schizophrenia treatment, PDE4 inhibitor transdermal patch)
CounterpartyAlto Neuroscience, Inc. (listed on a New York securities market)
Counterparty overviewA U.S. drug discovery biotech company based in Los Altos, California.
Relationship with the CompanyAlto-101 is being developed in partnership with Alto. We will discuss the detailed analysis of the trial results, including the possibility of improving the formulation.
Applicable areaTreatment of patients with schizophrenia and treatment related to cognitive function
Quantitative EffectsPrimary endpoint theta-band measure: n=83, d=0.34, p=0.052. Subgroup with impaired cognitive function: n=59, d=0.44, p=0.03.
Impact on Business PerformanceThe impact on results for the current fiscal year will be minor.
Items this document does not state (11)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleUsage historySource

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.

Although statistical significance was not achieved for the primary endpoint, certain electroencephalographic measures showed a trend toward improvement. Alto also announced its policy of prioritizing the allocation of resources to Alto-207, its lead pipeline candidate.

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Preliminary Results from the Alto-101 Phase 2 Clinical Trial | Medrx Co.,Ltd. (4586) timely disclosure | Komori