# A Novel Bone Targeted Antibiotic Therapy for the Treatment of Infected Fractures

> **NIH NIH R44** · BIOVINC, LLC · 2024 · $978,787

## Abstract

ABSTRACT
 Bone fracture is a large medical problem in the US, with 6 million presentations each year, resulting in
very large cost burdens. In addition, the total burden of fractures in the US is growing due to the aging of the
population and increases in osteoporosis. Some of these fractures do not heal properly, largely due to infections
resulting in high additional costs and morbidity in this subset of patients. Also, open fractures, often caused by
trauma, can lead to a very high rate of infection (20-30%), which might result in nonunion or amputation even
with the best of care. Reducing this significant burden to both the quality of life of the patients affected and to
the US public health and health systems is a very significant need. Bisphosphonates (BPs) are a class of
therapeutic compounds used to treat bone resorptive disorders, and accumulate in bone with exceptionally high
affinity, which makes them an excellent moiety for a novel bone targeted drug delivery platform.
 BioVinc is a company founded to be a leader in bone related diseases and has an extensive amount of
preliminary data showing the feasibility of using novel bone targeted bisphosphonate conjugated fluoroquinolone
compounds as a treatment for bone fracture healing problems. In this FastTrack SBIR proposal we will move the
BioVinc solution for infected delayed/non-union fracture toward commercial use. Our plan is to identify the ideal
clinical development candidate and complete the necessary nonclinical studies in order to advance our lead to
the stage of IND enabling studies to support IND application for first in human safety trials. In order to determine
the optimal doses of the conjugates and to get an initial safety assessment of the pharmacokinetics and
toxicology, studies will be conducted to confirm the opportunity for a development pathway. Specifically, we will
carry out two phases with four aims: Phase I Aim One. Improve synthesis of the BP-fluoroquinolone lead
compound to demonstrate that scale up to commercial quantities will be feasible; Phase I Aim Two. Carry out
initial pharmacokinetic studies in the mini pig to demonstrate skeletal exposure in the animal to be used for
pivotal IND enabling efficacy studies; Phase II Aim One. Further improve synthetic methodology to allow the
preparation of the BP-fluoroquinolone at the 50-100 gram scale to provide material to support efficacy studies in
mini pig and develop the process chemistry for large scale synthesis of the lead compound transferable to kg
GMP production with preliminary salt and polymorph screening; Phase II Aim Two. Test the lead compound for
its efficacy in the mini pig model of surgical repair of fractures.
 Successful completion of the proposed work will provide the preclinical data necessary to commercialize
our innovative product for use in infected fractures. This will meet a significant unmet medical need to reduce
the morbidity and mortality associated with poor healing, multiple surgeries, r...

## Key facts

- **NIH application ID:** 11020355
- **Project number:** 4R44AI175069-02
- **Recipient organization:** BIOVINC, LLC
- **Principal Investigator:** Frank H. Ebetino
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $978,787
- **Award type:** 4N
- **Project period:** 2024-04-22 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11020355

## Citation

> US National Institutes of Health, RePORTER application 11020355, A Novel Bone Targeted Antibiotic Therapy for the Treatment of Infected Fractures (4R44AI175069-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11020355. Licensed CC0.

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