NOV004

Precision therapy for faster, stronger fracture repair

Based on the discovery of compounds that accelerate bone regeneration and repair, as well as breakthroughs in highly selective targeting methods, Novosteo has designed a series of fracture-targeted drugs. These therapeutic agents concentrate the drug specifically at the fracture site, thereby greatly accelerating and improving the healing process and clinical outcome.  

Precision therapy for faster, stronger fracture repair

Based on the discovery of compounds that accelerate bone regeneration and repair, as well as breakthroughs in highly selective targeting methods, Novosteo has designed a series of fracture-targeted drugs. These therapeutic agents concentrate the drug specifically at the fracture site, thereby greatly accelerating and improving the healing process and clinical outcome.  

Targeting Ligand
Linker

TARGETING LIGAND

  • 25+ compounds tested In Vivo
  • Oligopeptide – high affinity for bone damage
Therapeutic Agent

PAYLOAD

  • 70+ compounds tested In Vivo
  • Parathyroid hormone family (Forteo/Tymlos)

FRACTURES & SPINAL FUSION

Each year in the U.S., there are more than 18 million fractures leading to more than $30 billion in direct medical costs.  This problem is compounded by a generally aging population in which the frequency of osteoporosis and the rate of life-threatening fractures is dramatically increased.

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INJURY SPECIFIC TREATMENT

Despite current therapies, ~25% of those 65 and older with hip fractures will die within a year due to fracture-associated complications.”

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RARE BONE DISEASE

Osteogenesis imperfecta affects up to 50,000 patients per year in the U.S. and some patients will break >400 bones in a lifetime.  Currently these patients have no available treatments beyond surgery and immobilization, with the associated clinical and quality of life impact.

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Injury Specific Treatment

Despite current therapies, ~25% of those 65 and older with hip fractures will die within a year due to fracture-associated complications.

Rare Bone Disease

Osteogenesis imperfecta affects up to 50,000 patients per year in the U.S. and some patients will break >400 bones in a lifetime.  Currently these patients have no available treatments beyond surgery and immobilization, with the associated clinical and quality of life impact.

Fractures

Each year in the U.S., there are more than 18 million fractures leading to more than $30 billion in direct medical costs.  This problem is compounded by a generally aging population in which the frequency of osteoporosis and the rate of life-threatening fractures is dramatically increased.

Fractures

Injury Specific Treatment

Rare Bone Disease

Despite current therapies, ~25% of those 65 and older with hip fractures will die within a year due to fracture-associated complications.

Osteogenesis imperfecta affects up to 50,000 patients per year in the U.S. Some patients with this rare disease will break more than 400 bones in their lifetime. There is a clear need for improved treatment options beyond surgery and immobilization, which have associated clinical and quality of life impact.

Each year in the U.S., there are more than 18 million fractures leading to more than $30 billion in direct medical costs. This problem is compounded by an aging population in which the frequency of osteoporosis and the rate of life-threatening fractures is dramatically increased.

NOV004: Based on In Vivo Efficacy Studies

Concentrates and keeps drug at bone fracture site

Dramatic increase in efficacy

Fracture targeting allows for a substantial safety window

NOV004 Concentrates and is Retained in Fractured Bone

NOV004’s uniquely engineered structure not only gives it specificity for the bone fracture, but also improves the half-life of the drug 8-fold allowing for less frequent drug administration. This improved retention of NOV004 at the bone fracture surface improves the ability to stimulate a robust healing response.

NOV004 Results in Stronger Bone

In preclinical studies, the targeted nature of NOV004 concentrates the therapeutic at the bone fracture site, increasing new bone production 3-fold and producing bone that is almost twice as dense as bone treated with the non-targeted therapeutic.  At three weeks post fracture, NOV004 treatment reached pre-fracture strength and more than doubled control strength.

New bone
Dense bone
Strong bone

NOV004 Results in Stronger Bone

The targeted nature of NOV004 concentrates the therapeutic at the site of the bone fracture while minimizing the systemic exposure. This allows NOV004 to stimulate the production of four times as much new bone at the fracture site. The new bone that is produced is almost twice as dense bone as the bone treated with the non-targeted therapeutic. This improved density and the increased production of quality bone leads to the restoration of pre-fracture strength of bones. With bones reaching their original pre-fracture strength in three weeks of treatment as opposed to controls taking 8-9 weeks to reach pre-fracture strength. This improved strength will allow for earlier stabilization of fractures and earlier mobilization of fracture patients.

New bone
Dense bone
Strong bone

NOV004 Improves the Functionality of the Broken Bone During its Repair

In preclinical studies, NOV004 treatment not only stimulates production of bone with greater structural and mechanical properties but also increases the functionality of the broken bone during recovery.  Increased bone stabilization and ability to bear weight results in a significant mobility gain as early as 12 days post-fracture.  NOV004 treatment increases velocity and distance traveled as well as improving functionality and decreasing pain signals.

NOV004 Effective In Vivo in Osteogenesis Imperfecta

In vivo efficacy models find that NOV004 dramatically improves the fracture healing in osteogenesis imperfecta, a rare bone disease, which is caused by a congenital defect in the genetic code for collagen. These individuals suffer from very brittle bone that fractures frequently. In the type III variant of this disease, one of its most severe forms, patients can have more than 400 fractures in their lifetime. In an animal model of type III disease, NOV004 has demonstrated that it doubles the density of the bone at the fracture site and improves bone strength almost 3-fold.

NOV004

NV004

SAD and MAD Bone Fracture Studies

We've engineered over 25 Oglopeptides possessing a high affinity for bone damage. Used to deliver 70 different bone treatment payloads to fracture sites, bone tissue repair was significantly accelerated.

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Phase 1
INd

NV004

Spinal Fusion

We've engineered over 25 Oglopeptides possessing a high affinity for bone damage. Used to deliver 70 different bone treatment payloads to fracture sites, bone tissue repair was significantly accelerated.

Phase 1
INd
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NV004

Osteogenesis Perfecta

We've engineered over 25 Oglopeptides possessing a high affinity for bone damage. Used to deliver 70 different bone treatment payloads to fracture sites, bone tissue repair was significantly accelerated.

Phase 1
INd
LEARN MORE