NGI226 for Achilles Tendinopathy

Recruiting at 10 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anticoagulants, Anti-infectives

Disqualifiers: Peripheral vascular disease, Cardiac disease, DVT, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulant medication (blood thinners).

What makes the drug NGI226 unique for treating Achilles tendinopathy?

NGI226 is unique because it uses microparticles for delivery, which may offer a novel way to administer treatment compared to traditional methods. This approach could potentially improve the drug's effectiveness and patient compliance by providing a more controlled release and reducing the need for frequent dosing. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing an injection called NGI226 MP for people with a specific type of Achilles tendon injury. The goal is to see if this injection can make the injured tendon stronger and more flexible. Researchers will compare the results to ensure safety and effectiveness.

Eligibility Criteria

This trial is for individuals with mid-portion Achilles tendinopathy lasting over 8 weeks but less than a year, who haven't improved after at least 6 weeks of standard treatments like physiotherapy or NSAIDs. It's not suitable for those with conditions affecting injection safety, history of blood clots or frequent infections, past ankle surgeries or significant heart disease.

Inclusion Criteria

Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible

I have Achilles tendinopathy diagnosed by a doctor and confirmed by ultrasound or MRI, with symptoms lasting more than 8 weeks but less than 12 months.

My Achilles tendinopathy hasn't improved after 6 weeks of treatments like physiotherapy.

Exclusion Criteria

I don't have conditions that risk safety of tendon injections.

I have had a severe Achilles tendon injury.

I frequently get infections, including cold sores or genital herpes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single peritendon injection of NGI226 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• NGI226
• Placebo

Trial Overview The study is testing the safety and effectiveness of NGI226 Microparticles given as a single peritendon injection to improve Achilles tendon mechanical properties compared to a placebo in patients with Achilles tendinopathy.

Participant Groups

Group I: NGI226 Experimental Treatment 1 Intervention

single peritendon injection

Group II: Placebo Placebo Group 1 Intervention

single peritendon injection

NGI226 is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as NGI226 Microparticles for:

• Achilles tendinopathy

Approved in United States as NGI226 Microparticles for:

• Achilles tendinopathy

Approved in United Kingdom as NGI226 Microparticles for:

• Achilles tendinopathy

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

The novel gel encapsulated coated microneedles (GEC-MNs) demonstrated a significantly improved drug delivery efficiency of 88.42% compared to 72.02% for traditional water-soluble coated microneedles, indicating enhanced effectiveness for biopharmaceutical delivery.

GEC-MNs provided a sustained release of the drug rhIFNα-1b, showing a longer elimination half-life of 18.16 hours compared to 1.44 hours for soluble coated microneedles and 2.53 hours for intradermal injections, suggesting better stability and prolonged therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced delivery efficiency and sustained release of biopharmaceuticals by complexation-based gel encapsulated coated microneedles: rhIFNα-1b example. Zhou, Z., Zhang, S., Yang, G., et al.[2021]

In a study involving 2,206 patients with moderate to severe knee osteoarthritis, oral salmon calcitonin (sCT) did not show a significant effect on joint space narrowing over 24 months, indicating it may not modify the structural progression of the disease.

While some improvements were noted in pain and function scores using the WOMAC questionnaire, these results were not statistically significant due to the study's testing procedures, suggesting limited clinical benefits of this formulation of oral sCT for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Karsdal, MA., Byrjalsen, I., Alexandersen, P., et al.[2017]

Gelatin microspheres loaded with calcitonin gene-related peptide (CGRP) or substance P significantly enhanced bone formation in a rabbit model of osteoporosis over a 3-month period, indicating their potential as therapeutic agents for bone repair.

The optimal concentration for CGRP was found to be 10 nM, while 1 µM of substance P also showed strong osteogenic effects, suggesting that both compounds can be effective in promoting bone healing in osteoporotic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gelatin microspheres containing calcitonin gene-related peptide or substance P repair bone defects in osteoporotic rabbits. Chen, J., Liu, W., Zhao, J., et al.[2018]

The study developed two new dissolving microneedle arrays (DMNAs) for delivering salmon calcitonin (sCT) transdermally, which significantly improved the drug's bioavailability to about 70%, addressing the limitations of traditional injection and nasal spray methods.

The addition of trehalose in the DMNA formulation enhanced the stability of sCT under challenging conditions, suggesting that this method could provide a safer and more efficient treatment option for bone disorders with less pain for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal Delivery of Salmon Calcitonin Using a Dissolving Microneedle Array: Characterization, Stability, and In vivo Pharmacodynamics. Zhang, L., Li, Y., Wei, F., et al.[2021]

The study developed a nanoparticulate system for delivering BMP-2, which showed that PEI coating effectively reduced the initial release of BMP-2 but also caused toxicity that inhibited bone formation.

Higher BMP-2 loading in the nanoparticles improved bone induction, suggesting that while controlling release is important, the formulation must minimize toxicity to enhance osteoinductive efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and bone formation by BMP-2 entrapped in polyethylenimine-coated albumin nanoparticles. Zhang, S., Doschak, MR., Uludağ, H.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Enhanced delivery efficiency and sustained release of biopharmaceuticals by complexation-based gel encapsulated coated microneedles: rhIFNα-1b example. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Gelatin microspheres containing calcitonin gene-related peptide or substance P repair bone defects in osteoporotic rabbits. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Transdermal Delivery of Salmon Calcitonin Using a Dissolving Microneedle Array: Characterization, Stability, and In vivo Pharmacodynamics. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and bone formation by BMP-2 entrapped in polyethylenimine-coated albumin nanoparticles. [2017]