What is the mechanism of action of this treatment?

The most common treatments for Osteogenesis Imperfecta (OI) include bisphosphonates, which inhibit bone resorption by osteoclasts, leading to increased bone density and reduced fracture rates. Growth hormone therapy can also be used to enhance bone growth and density. These treatments are crucial for OI patients as they help to strengthen bones, reduce the frequency of fractures, and improve overall quality of life. Surgical interventions may also be necessary to correct bone deformities and improve mobility.

What side effects are associated with this type of intervention?

Common treatments for Osteogenesis Imperfecta include bisphosphonates, teriparatide, and growth hormone therapy. Bisphosphonates can cause side effects such as gastrointestinal issues, acute phase reactions, and osteonecrosis of the jaw. Teriparatide may lead to hypercalcemia, dizziness, and leg cramps. Growth hormone therapy can result in joint and muscle pain, insulin resistance, and increased intracranial pressure. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Osteogenesis Imperfecta (OI), primarily focusing on bisphosphonates like pamidronate and zoledronic acid, which help increase bone density and reduce fracture rates. Additionally, teriparatide, a recombinant form of parathyroid hormone, has been used off-label to enhance bone formation. These treatments aim to improve bone strength and reduce the frequency of fractures in patients with OI.

What other types of research exist?

Promising novel alternatives to AGA2115 for Osteogenesis Imperfecta patients include therapies targeting the underlying genetic defects or enhancing bone strength. One potential alternative is the use of anti-sclerostin antibodies, which have shown promise in increasing bone formation and strength. Another option could be gene therapy approaches aimed at correcting the specific genetic mutations responsible for OI. Additionally, treatments that enhance collagen production or stability, such as bisphosphonates or newer anabolic agents like teriparatide, may also be considered.

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Monoclonal Antibodies

AGA2115 for Osteogenesis Imperfecta

Phase 1

Recruiting

Research Sponsored by Angitia Incorporated Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part C: Male and female adults ≥18 to ≤25 years old and adolescents ≥12 to ≤17 years old with a clinical diagnosis of OI Type I (mild) with a defect in COL1A1 and/or COL1A2, as confirmed by genetic testing.

Parts A and B: Healthy men and women ≥18 to ≤65 years old.

Must not have

Part C: History of skeletal malignancies or bone metastases at any time.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

Summary

This trial aims to determine if the new drug AGA2115 is safe and well-tolerated by healthy adults. Researchers are testing it on healthy volunteers to ensure it does not cause harmful side effects.

Who is the study for?

This trial is for healthy adults aged 18-65, and individuals aged 12-25 with mild Osteogenesis Imperfecta (OI) confirmed by genetic testing. Participants must have sufficient Vitamin D levels and agree to take supplements during the trial. Exclusions include recent severe cardiovascular events, certain cancers within the last 5 years, calcium level disorders, sensitivity to biologics, pregnancy or breastfeeding.

What is being tested?

The study is evaluating AGA2115's safety and tolerability in healthy volunteers as well as those with OI when administered in single or multiple doses. The comparison will be made against a placebo to determine any differences in response between the two groups.

What are the potential side effects?

While specific side effects of AGA2115 are not listed here, common side effects from similar trials may include reactions at the injection site, general discomfort or pain, potential allergic reactions due to sensitivity to mammalian-derived drug preparations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12-25 years old with mild Osteogenesis Imperfecta Type I, confirmed by genetic tests.

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I am a healthy adult between 18 and 65 years old.

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My Vitamin D levels are sufficient, and I agree to take Calcium and Vitamin D supplements during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had cancer in my bones or bone metastases before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-emergent adverse events (TEAEs)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AGA2115Experimental Treatment1 Intervention

In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteogenesis Imperfecta (OI) include bisphosphonates, which inhibit bone resorption by osteoclasts, leading to increased bone density and reduced fracture rates. Growth hormone therapy can also be used to enhance bone growth and density. These treatments are crucial for OI patients as they help to strengthen bones, reduce the frequency of fractures, and improve overall quality of life. Surgical interventions may also be necessary to correct bone deformities and improve mobility.

Clinical and biochemical effects of impeded androgen (oxymetholone) therapy of hereditary angioedema.D-penicillamine reverses the inhibition of proteoglycan biosynthesis caused by exposure of cultured articular cartilage to hydrogen peroxide.Another look at the pentoxifylline efficacy data for intermittent claudication.