Novel Bone Forming Compound for Use in Spinal Fusion Device

Application

Bone forming therapeutic for use in spinal fusion devices and treatment of systemic bone diseases and disorders.

Key Benefits

  • Current devices for bone grafting procedures require high concentrations of bone morphogenic protein (BMP) which results in a high cost and create a barrier for routine clinical use.
  • Commercially available small molecule therapeutics that modulate Smurf1 (part of the signaling pathway for BMP) have been identified and these compounds induce bone formation.
  • Lead compound is a major metabolite of a currently marketed, FDA-approved anti-microbial drug with broad labeling (includes women of child bearing age and children).

Market Summary

Millions of bone grafting procedures are performed worldwide each year. In spinal fusions the bone healing failure rate may be as high as 40%. The iliac crest is often used as a donor site for autologous grafts but there are many complications that can develop from this type of bone graft harvesting including pain, nerve damage, and hematoma. There is also limited supply of iliac bone as well as substantial cost associated with this surgery. Bone morphogentic proteins (BMP) are being used increasingly in orthopedic surgeries. These small molecules are capable of inducing new bone formation when delivered in the appropriate concentration and on the appropriate scaffold and do not require harvesting bone from remote sites of the patient. The FDA has approved several devices including INFUSETM which is used in spinal surgeries. The high cost and need for high concentrations of BMP create barriers for routine clinical use so there is a need for other compounds that can substitute or complement the use of BMPs.

Technical Summary

Cellular response to BMPs depends on intracellular signaling pathways involving proteins called Smads. The baseline level of Smads is in part affected by their ability to interact with another protein, Smurf1. Smurf1 interacts with Smad1/5 and targets them for degradation leading to reduced BMP signaling. Therefore, therapeutics that modulate the effects of Smurf1 may have the potential to replace or complement BMP. Emory researchers have identified compounds that interact with Smurf1. These compounds potentiate the effects of BMP-2 and induce osteoblastic differentiation of C2C12 myoblasts in vitro in a dose dependent manner. Emory investigators have identified a lead compound, SVAK-12X, which is a major metabolite of an FDA-approved anti-microbial drug currently on the market.

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Patent Information

App Type Country Serial No. Patent No. File Date Issued Date Patent Status
Nationalized PCT - Foreign Australia 2011291980 2011291980 8/18/2011 7/23/2015 Issued
EP Registered Country France 11818776.4 2605804 8/18/2011 3/14/2017 Issued
EP Registered Country United Kingdom 11818776.4 2605804 8/18/2011 3/14/2017 Issued
Nationalized PCT - United States United States 13/816,312 9,511,071 2/11/2013 12/6/2016 Issued
Nationalized PCT - Foreign Canada 2,808,655 2,808,655 2/15/2013 11/26/2019 Issued
Nationalized PCT - Foreign EP 11818776.4 2605804 2/18/2013 3/14/2017 Issued
EP Registered Country Germany 11818776.4 2605804 2/18/2013 3/14/2017 Issued
Divisional United States 15/334,030 9,808,464 10/25/2016 11/7/2017 Issued
Divisional EP 17152900.1 3187197 1/24/2017 1/1/2020 Issued
EP Registered Country France 17152900.1 3187197 1/24/2017   Issued
EP Registered Country Germany 17152900.1 3187197 1/24/2017   Issued
EP Registered Country United Kingdom 17152900.1 3187197 1/24/2017   Issued
Continuation United States 15/801,964 10,537,577 11/2/2017 1/21/2020 Issued
Divisional Canada 3,052,927   8/23/2019   Pending
Continuation United States 16/732,959 10,888,565 1/2/2020 1/12/2021 Issued
Continuation United States 17/122,853 11,471,461 12/15/2020 10/18/2022 Issued
Tech ID: 10164
Published: 2/15/2012
Category
Therapeutics

Contact
Jessica Beach
Marketing Specialist
Emory, OTT
(404) 727-1899
jbeach4@emory.edu

Inventor(s)
Scott Boden
Sreedhara Sangadala

Keyword(s)
Musculoskeletal
Regenerative Medicine
Repurposed Drug
Small Molecule