Targeted & controlled bone healing
03 Sep 19
Kuros Biosciences Announces U.S. FDA approval of IND Application to Initiate Fibrin-PTH Phase 2a Clinical Trial in Spinal Fusion

Kuros Biosciences Announces U.S. FDA approval of IND Application to Initiate Fibrin-PTH Phase 2a Clinical Trial in Spinal Fusion

  • Kuros to conduct Phase 2a trial in spinal fusion, comparing Fibrin-PTH to autograft
  • Primary endpoint is radiographic interbody fusion at 12 months

Schlieren (Zurich), Switzerland, September 3, 2019 – Kuros Biosciences, a leader in next generation bone graft technologies, today announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial to evaluate the use of Fibrin-PTH (KUR-113) in single level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease, with autograft (patient’s own bone) as comparator.

 

This IND application is considered the first ever approval by the FDA to evaluate a drug/biologic combination product candidate for lumbar interbody fusion of the spine.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “The IND approval is an important milestone for Kuros allowing us to advance the clinical program for Fibrin-PTH in spinal fusion into Phase 2a. Fibrin-PTH targets a substantial clinical need, and, if successful, opens up a huge commercial opportunity.”

 

The planned clinical study is a prospective, randomized, controlled, open-label, multi-center, parallel group study with the primary endpoint of radiographic interbody fusion, using CT-scans at 12 months, determined by an independent radiology expert panel.



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kurosbio.com

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    KUR-113
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    KUR-113
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    Neuroseal (KUR-023)

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Article
03 Sep 19
Kuros Biosciences Announces U.S. FDA approval of IND Application to Initiate Fibrin-PTH Phase 2a Clinical Trial in Spinal Fusion

Kuros Biosciences Announces U.S. FDA approval of IND Application to Initiate Fibrin-PTH Phase 2a Clinical Trial in Spinal Fusion

  • Kuros to conduct Phase 2a trial in spinal fusion, comparing Fibrin-PTH to autograft
  • Primary endpoint is radiographic interbody fusion at 12 months

Schlieren (Zurich), Switzerland, September 3, 2019 – Kuros Biosciences, a leader in next generation bone graft technologies, today announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial to evaluate the use of Fibrin-PTH (KUR-113) in single level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease, with autograft (patient’s own bone) as comparator.

 

This IND application is considered the first ever approval by the FDA to evaluate a drug/biologic combination product candidate for lumbar interbody fusion of the spine.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “The IND approval is an important milestone for Kuros allowing us to advance the clinical program for Fibrin-PTH in spinal fusion into Phase 2a. Fibrin-PTH targets a substantial clinical need, and, if successful, opens up a huge commercial opportunity.”

 

The planned clinical study is a prospective, randomized, controlled, open-label, multi-center, parallel group study with the primary endpoint of radiographic interbody fusion, using CT-scans at 12 months, determined by an independent radiology expert panel.