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DSM265

Phase 1

Malaria | Small molecule | Infectious Disease |CNS Pharmaceuticals, Inc.|Last Updated: Oct 7, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

DSM265 · 1 trial · 1 indication

Phase 1 1
NCT02389348A Phase Ib Induced Malaria Infection Study With the Combination of OZ439 and DSM265Malaria
COMPLETED13 Analytics
PHASE1COMPLETED
A Phase Ib Induced Malaria Infection Study With the Combination of OZ439 and DSM265
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

PK/PD relationship on clearance of P falciparum parasites from the blood
From treatment administration to clearance of parasites or administration of Standard of Care therapy, whichever comes first, and up to 42 days following inoculum

The Parasite Reduction Ratio (PRR) is estimated using the slope of the optimal fit of the log-linear relationship of the parasitemia decay.

Secondary Endpoints

Incidence, relation to study drug and severity of AE
From challenge inoculum and up to 42 days following inoculum
Cmax, Tmax, AUC of DSM265 and OZ439
From Drug administration up to 42 days following inoculum
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
combination OZ439 and DSM265EXPERIMENTALSubjects will receive 1800 P falciparum infected red blood cells. Development of parasitemia will be monitored by quantitative PCR. When the parasitemia reached the threshold of 1000 p/ml subjects will receive a single oral dose of OZ439 and DSM265. Subsequent doses in subsequent cohort(s) will be determined following a review of observed OZ439 and DSM265 safety, and pharmacokinetic and pharmacodynamic interaction outcomes as well as the activity of the drugs as defined by parasite clearance kinetics.

Interventions

NameTypeDescription
DSM265DRUGSingle oral doses of DSM265
OZ439DRUGSingle oral doses of OZ439
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Demography * Adults (male and non-pregnant and non-lactating females) participants between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the antimalarial drug treatment) and be contactable and available for the duration of the tri...

Countries:Australia
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Competitive Landscape -Malaria 6 trials

Frequently asked questions about DSM265

What is DSM265?

DSM265 is an investigational small molecule being developed for the treatment of malaria. It is currently in Phase 1 clinical development and is being studied as part of a combination therapy for malaria.

What is DSM265 used for?

DSM265 is being developed for use in malaria. It is currently being studied in a Phase 1 clinical trial for the treatment of malaria, specifically in an induced malaria infection study.

Who makes DSM265?

DSM265 is being developed by CNS Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol CNSP.

What phase is DSM265 in?

DSM265 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not been approved by regulatory authorities.

What clinical trials is DSM265 in?

DSM265 has been studied in one completed Phase 1 clinical trial, identified as NCT02389348. This trial was an induced malaria infection study that evaluated the combination of OZ439 and DSM265 in healthy volunteers in Australia.

Is DSM265 FDA approved?

DSM265 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for the treatment of malaria.