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Gimsilumab - Kinevant Sciences

Drug Profile

Gimsilumab - Kinevant Sciences

Alternative Names: KIN 1901

Latest Information Update: 17 Apr 2020

At a glance

  • Originator Kinevant Sciences GmbH
  • Developer Kinevant Sciences GmbH; Roivant Sciences
  • Class Anti-inflammatories; Antineoplastics; Antirheumatics; Monoclonal antibodies
  • Mechanism of Action Granulocyte macrophage colony stimulating factor antagonists; Granulocyte-macrophage colony stimulating factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Adult respiratory distress syndrome
  • Phase I Ankylosing spondylitis

Most Recent Events

  • 15 Apr 2020 Phase II clinical trials in Adult respiratory distress syndrome (In patients with COVID-2019 infections) in USA (IV) (NCT04351243)
  • 27 Mar 2020 Roivant Sciences completes a phase I trial in Ankylosing spondylitis in Canada (NCT04205851)
  • 18 Mar 2020 Roivant Sciences intends to seek regulatory approval by regulatory authorities for initiating clinical trials of gimsilumab in Acute respiratory distress syndrome (in patients with COVID-2019)

Development Overview

Introduction

Gimsilumab is a fully human immunoglobulin monoclonal antibody being developed by Kinevant Sciences, as a subcutaneous formulation for the treatment of inflammation and rheumatic diseases including ankylosing spondylitis and as a intravenous formulation for the treatment of acute respiratory distress syndrome in patients with COVID-2019 infections. It targets granulocyte-macrophage colony stimulating factor (GM-CSF, CSF2), a growth factor involved in inflammation and autoimmunity. It is found in synovial fluid in patients suffering from spondyloarthritis. Clinical development is underway in Canada for ankylosing spondylitis and the US for lung injury or acute respiratory distress syndrome (ARDS), in patients with COVID-2019 infections.

It is possible that Kinevant Sciences has acquired the gimsilumab from Eisai Inc, but neither Eisai Inc nor Kinevant Sciences have confirmed this as of January 2020 [see Adis Insight drug profile 800018578].

Key Development Milestones

In April 2020, Roivant Sciences initiated and dosed the first patient in a randomised, double-blind, placebo-controlled phase II BREATHE trial evaluating the impact of intravenous (IV) treatment with gimsilumab on mortality in COVID-19 patients with lung injury or acute respiratory distress syndrome (ARDS) (NCT04351243; KIN-1901-2001). and the first patient was dosed. In May 2020, the independent Data Monitoring Committee (DMC) recommended continuation of the trial based on review of available safety data, post after six days of follow-up. Roivant also reported amendment in the protocol of the trial which allow the use of investigational antivirals such as remdesivir during the study, as well as treatment with convalescent plasma prior to enrolment. As at May 2020, 56 patients were enrolled in the trial. The trial intends to enrol approximately 270 patients in the US. Earlier, In March 2020, Roivant Sciences reported that it intends to commence clinical trials of gimsilumab in patients with COVID-19 upon approval by relevant regulatory authorities [1] [2] [3] [4] [5] .

As of March 2020, Roivant Sciences was in discussion with regulators in the United States, Europe, and Asia to advance the clinical development of gimsilumab for the treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection [3] .

In March 2020, Roivant Sciences completed the phase I trial that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous gimsilumab (KIN 1901) in healthy participants and participants with ankylosing spondylitis (NCT04205851; KIN-1901-1001). Earlier, in March 2020, the company had reported that dosing of the patients in the trial was completed and, released the safety results from the trial. The randomised, double-blind , placebo-controlled trial was initiated in November 2019 and enrolled 46 participants in Canada [6] [3] [7] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Injection, unspecified
  • Class Anti-inflammatories, Antineoplastics, Antirheumatics, Monoclonal antibodies
  • Target Granulocyte macrophage colony stimulating factor; Granulocyte-macrophage colony stimulating factor receptor
  • Mechanism of Action Granulocyte macrophage colony stimulating factor antagonists; Granulocyte-macrophage colony stimulating factor receptor antagonists
  • WHO ATC code

    M01 (Antiinflammatory and Antirheumatic Products)

    R07A-X (Other respiratory system products)

  • EPhMRA code

    M1 (Anti-Inflammatory and Anti-Rheumatic Products)

    R7X (All Other Respiratory System Products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Adult respiratory distress syndrome In patients with COVID-2019 infections - Phase II USA IV / unspecified Roivant Sciences 15 Apr 2020
Ankylosing spondylitis - - Phase I Canada SC / Injection Kinevant Sciences GmbH 12 Nov 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Kinevant Sciences GmbH Originator Switzerland
Kinevant Sciences GmbH Owner Switzerland
Roivant Sciences Collaborator Bermuda

Scientific Summary

Adverse Events

Phase I

In a phase I trial conducted in healthy volunteers, gimsilumab demonstrated a favorable safety and tolerability profile with no serious adverse events reported [3] [7] .

Development History

Event Date Update Type Comment
15 Apr 2020 Phase Change - II Phase II clinical trials in Adult respiratory distress syndrome (In patients with COVID-2019 infections) in USA (IV) (NCT04351243) [2] [1] Updated 17 Apr 2020
27 Mar 2020 Trial Update Roivant Sciences completes a phase I trial in Ankylosing spondylitis in Canada [6] (NCT04205851) Updated 01 Apr 2020
18 Mar 2020 Regulatory Status Roivant Sciences intends to seek regulatory approval by regulatory authorities for initiating clinical trials of gimsilumab in Acute respiratory distress syndrome (in patients with COVID-2019) [3] Updated 26 Mar 2020
18 Mar 2020 Scientific Update Safety data from a phase I trial in volunteers and in patients with Ankylosing spondylitis released by Roivant Sciences [3] Updated 26 Mar 2020
18 Mar 2020 Trial Update Roivant Sciences plans clinical trials of gimsilumab in Acute respiratory distress syndrome (in patients with COVID-19) [3] Updated 26 Mar 2020
12 Nov 2019 Phase Change - I Phase-I clinical trials in Ankylosing spondylitis in Canada (SC, Injection) (NCT04205851) Updated 31 Dec 2019

References

  1. Roivant Provides Updates for Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19 Patients for the Prevention and Treatment of Acute Respiratory Distress Syndrome.

    Media Release
  2. Roivant Doses First Patient in Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19 Patients for the Prevention and Treatment of Acute Respiratory Distress Syndrome.

    Media Release
  3. Roivant Announces Development of Anti-GM-CSF Monoclonal Antibody to Prevent and Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19.

    Media Release
  4. A study assessing gimsilumab for the treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

    ctiprofile
  5. A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19.

    ctiprofile
  6. Altasciences Completes Phase I Study on Gimsilumab for ARDS in COVID-19.

    Media Release
  7. An Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Gimsilumab in Healthy Subjects and Subjects With Ankylosing Spondylitis

    ctiprofile
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