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KIN-1901

Phase 2

Inflammation | Small molecule | Immunology |Roivant Sciences Ltd.|Trials Updated: Dec 14, 2021

KIN-1901 development status

Highest phase Phase 2 (NCT04351243)
Phase scored for ROIVPhase 1
Registered trials 2 across 1 sponsor since Dec 2019

KIN-1901 target and mechanism

ModalitySmall molecule

Also known as Gimsilumab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment263

FDA Designations

No designations recorded

KIN-1901 clinical trials

KIN-1901 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT04351243A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)COVID-19
COMPLETED227 Analytics
PHASE2COMPLETED
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Mortality
Day 43

"Incidence" is defined as the percent of subjects that died by Day 43

Incidence of treatment-emergent adverse events
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Change from baseline in QTcF interval
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Change in clinical chemistry parameter hsCRP determined by laboratory testing
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Incidence of serum anti-drug antibodies
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)

Secondary Endpoints

Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation
Day 29
Number of Ventilator-free Days
Baseline to Day 29
Time to Hospital Discharge
Baseline to Day 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GimsilumabEXPERIMENTALGimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
PlaceboPLACEBO_COMPARATORNormal saline on Day 1 Normal saline on Day 8
KIN-1901EXPERIMENTALSingle or repeat (once weekly for 4 weeks) KIN-1901 subcutaneous injection

Interventions

NameTypeDescription
GimsilumabDRUGGimsilumab is a fully human monoclonal antibody (mAb).
PlaceboDRUGNormal saline
KIN-1901DRUGKIN-1901 is a fully human monoclonal antibody (mAb).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: 1. Male or non-pregnant female age ≥18 years, inclusive 2. Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form 3. Has laboratory-conf...

Countries:United StatesCanada
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Frequently asked questions about KIN-1901

What is KIN-1901?

KIN-1901 is an investigational small molecule developed by Roivant Sciences Ltd. for inflammation. It has been studied in a Phase 1 clinical trial that enrolled healthy subjects and subjects with ankylosing spondylitis. KIN-1901 is not approved and remains in clinical development.

What is KIN-1901 used for?

KIN-1901 is being developed for inflammation, including rheumatic diseases. Its only recorded clinical trial enrolled healthy volunteers and subjects with ankylosing spondylitis. Because the program is at Phase 1, KIN-1901 is investigational and has no approved use.

Who makes KIN-1901?

KIN-1901 is developed by Roivant Sciences Ltd., which trades on the Nasdaq under the ticker ROIV. Roivant is the sponsor of the Phase 1 study of KIN-1901 in healthy subjects and subjects with ankylosing spondylitis.

What phase is KIN-1901 in?

KIN-1901 is in Phase 1. One Phase 1 trial has been completed, and no trials are currently active. The study was randomized, double-blind, and placebo-controlled, enrolling 36 participants. KIN-1901 is investigational and has not been approved for any indication.

What clinical trials is KIN-1901 in?

KIN-1901 has been studied in one clinical trial, NCT04205851, titled a Phase 1 study with KIN-1901 in healthy subjects and subjects with ankylosing spondylitis. That trial is completed, enrolled 36 participants, was placebo-controlled, and was conducted in Canada.

Is KIN-1901 approved by the FDA?

KIN-1901 is not approved. It is an investigational small molecule in Phase 1 development for inflammation, and its single completed trial was a Phase 1 study in healthy subjects and subjects with ankylosing spondylitis. No approval has been granted for any indication.