AGA2118 for Osteoporosis

(ARTEMIS Trial)

Recruiting at 45 trial locations

Overseen By Deborah Lium

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Angitia Incorporated Limited

Must not be taking: Bone metabolism agents

Disqualifiers: Fractures, Vitamin D deficiency, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the treatment AGA2118, a new potential drug, works compared to a placebo for improving bone density in the lower spine of postmenopausal women. It targets those with low bone mass, a condition where bones are weaker and more prone to fractures. The trial includes several groups testing different doses of AGA2118. Suitable candidates are postmenopausal women with low bone density who have not experienced major bone fractures. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in bone health.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using any medications that affect bone metabolism. If you're taking such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AGA2118 was promising in earlier studies. Initial results from clinical trials indicate that AGA2118 can help increase bone strength, which is important for treating osteoporosis. These studies have examined both the safety and tolerability of AGA2118.

The trials found that AGA2118 is generally well-tolerated, with most participants experiencing no serious side effects. The treatment's effect on bone strength increased with higher doses, but no major safety issues emerged in these early studies.

This trial is in an early stage, so participants receive close monitoring to ensure the treatment's safety. While more research is needed to confirm long-term safety, the initial results suggest that AGA2118 could safely increase bone strength in postmenopausal women with low bone mass. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

AGA2118 is unique because it's a potential new way to tackle osteoporosis, a condition often treated with medications like bisphosphonates and hormone-related therapies. Unlike these traditional treatments, which primarily focus on slowing bone loss, AGA2118 might offer a novel approach by potentially promoting new bone growth. Researchers are excited about this treatment because it could effectively strengthen bones and reduce fracture risks in a way that's different from existing options. This could be a game-changer for those with osteoporosis, offering hope for more robust bone health.

What evidence suggests that this trial's treatments could be effective for osteoporosis?

Research has shown that AGA2118, which participants in this trial may receive, effectively increases bone strength in postmenopausal women. Early results suggest that higher doses of AGA2118 lead to greater improvements in bone strength. Studies have found that AGA2118 helps by both building new bone and slowing bone loss. This dual action is important for strengthening bones, especially in individuals with osteoporosis. So far, AGA2118 has demonstrated safety, making it a promising treatment option. ^{3 4 5 6 7}

Who Is on the Research Team?

Ricardo Dent-Acosta, MD

Principal Investigator

Angitia Incorporated Limited

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with low bone mass, which often leads to osteoporosis. Participants should not have conditions that could interfere with the study or be on treatments that affect bone metabolism.

Inclusion Criteria

BMD T-score of ≤ -2.5 to > -3.5 at the lumbar spine, total hip, or femoral neck

I am a healthy woman aged 55 to 80 and have gone through menopause.

Exclusion Criteria

My thyroid condition is not being treated.

I am taking medication that affects bone health.

Vitamin D deficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive double-blind dosing regimens of AGA2118 or placebo for 12 months

12 months

Open-label extension

Participants continue on to a 12 month open-label period, re-randomized to continue, change, or discontinue treatment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGA2118

Trial Overview The trial is testing AGA2118 against a placebo to see if it can improve bone density in the lumbar spine after one year. It's a blind test, meaning participants won't know which treatment they're getting.

How Is the Trial Designed?

Group I: AGA2118 Dose Regimen 6 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group II: AGA2118 Dose Regimen 5 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group III: AGA2118 Dose Regimen 4 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group IV: AGA2118 Dose Regimen 3 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group V: AGA2118 Dose Regimen 2 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group VI: AGA2118 Dose Regimen 1 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group VII: Placebo Regimen Placebo Group 1 Intervention

Placebo selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Who Is Running the Clinical Trial?

Angitia Incorporated Limited

Lead Sponsor

Trials

2

Recruited

420+

Angitia Biopharmaceuticals

Lead Sponsor

Trials

4

Recruited

900+

Published Research Related to This Trial

Glucocorticoid treatment in female rats led to a significant decrease in bone mineral density (BMD) and deterioration of trabecular bone microarchitecture, indicating a risk for osteoporosis.

The study found that glucocorticoids may increase the expression of cannabinoid type 1 receptors (CB1R) in osteoclasts, suggesting a potential molecular mechanism contributing to glucocorticoid-induced osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of glucocorticoid on expression of cannabinoid-1 receptors in osteoclasts from tibial proximal metaphysis of rats]. Liu, SP., Chen, J., Dai, RC., et al.[2014]

Current osteoporosis treatments primarily focus on inhibiting bone resorption by osteoclasts, with established agents like bisphosphonates and SERMs reducing vertebral fractures by about 50%.

Newer agents in development, such as cathepsin K inhibitors and RANKL monoclonal antibodies, may enhance treatment efficacy, but further research is needed to determine if they can surpass the effectiveness of existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-resorptive therapies for osteoporosis. Reid, IR.[2013]

According to the new National Osteoporosis Foundation guidelines, a significant majority (72%) of U.S. white women aged 65 and older would be recommended for osteoporosis treatment based on specific criteria, including bone density measurements and fracture risk.

The Study of Osteoporotic Fractures (SOF) population showed higher femoral neck bone mineral density and was younger compared to the general U.S. population, indicating that the guidelines may lead to a high treatment recommendation rate among older women, particularly those over 75 (93%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimates of the proportion of older white women who would be recommended for pharmacologic treatment by the new U.S. National Osteoporosis Foundation Guidelines. Donaldson, MG., Cawthon, PM., Lui, LY., et al.[2022]

Over the past 25 years, new treatments for osteoporosis have significantly reduced fracture risks, with some agents lowering spine fractures by up to 70% and hip fractures by 40-50%.

Amino-bisphosphonates remain the primary treatment, while Denosumab, a new monoclonal antibody, and parathyroid hormone (the only anabolic agent) are also effective, particularly for severe cases of osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the treatment of osteoporosis. Eriksen, EF., Halse, J., Moen, MH.[2015]

Current osteoporosis treatments, primarily anti-resorptive agents like bisphosphonates and estrogen therapy, have limitations in efficacy and long-term safety, highlighting the need for new therapeutic targets.

Recent research identifies promising new targets for osteoporosis treatment, focusing on the RANK-RANKL-OPG system and Wnt/β-catenin signaling pathway, which could lead to more effective anti-resorptive and anabolic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapeutic targets for osteoporosis treatment. Chen, M., Qiao, H., Su, Z., et al.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05225857

A First-in-Human Study Evaluating AGA2118 in Men and ... The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/angitia-phase-ii-aga2118/

Angitia doses first subject in Phase II trial of AGA2118 The trial is designed to evaluate AGA2118's efficacy in increasing bone mineral density in postmenopausal women. Credit: Perfect Wave / ...

3. angitiabio.com angitiabio.com/news/item?id=56

ANGITIA - INNOVATION FOR PATIENTS This FIH study of AGA2118 demonstrated a favorable safety profile with rapid increase in bone formation and simultaneous decrease in bone ...

4. biospace.com biospace.com/press-releases/angitia-biopharmaceuticals-presents-first-in-human-data-on-aga2118-for-osteoporosis-at-asbmr-2024

Angitia Biopharmaceuticals Presents First-in-Human Data ... Clinical data demonstrated treatment with AGA2118 resulted in dose-dependent increases in bone mineral density.

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/530881

A Trial Evaluating Efficacy of AGA2118 in PostMenopausal ... The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD)

6. synapse.patsnap.com synapse.patsnap.com/article/angitia-biopharma-to-present-aga2118-osteoporosis-data-at-asbmr-2024

Angitia Biopharma to Present AGA2118 Osteoporosis Data ... The selected abstracts highlight both preclinical and clinical data for AGA2118, showcasing significant developments in osteoporosis treatment.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05225857

A First-in-Human Study Evaluating AGA2118 in Men and ... The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy ...