Rystiggo (rozanolixizumab)
Research Synopsis
- Rystiggo (rozanolixizumab) is an anti-FcRn monoclonal antibody that targets pathogenic IgG autoantibodies in autoimmune diseases.
- Early studies demonstrated its efficacy in reducing human serum IgG levels without increasing infection risk, establishing a favorable safety profile.
- Subsequent research has shown that rozanolixizumab effectively lowers plasma IgG levels in various preclinical models and continues to demonstrate safety during prolonged administration.
- Clinical trials are ongoing for rozanolixizumab in conditions like immune thrombocytopenia (ITP) and generalized myasthenia gravis (gMG), with promising results regarding platelet count improvements and symptom relief, respectively.
- A significant phase 2 trial in ITP revealed that over 50% of participants achieved clinically relevant platelet counts shortly after treatment, warranting further phase 3 investigations.
- In gMG, although clinical improvements were observed, further studies are needed to establish definitive efficacy, as the main measures did not yield statistically significant results.
- Research on pharmacokinetic models indicates dose-dependent effects of rozanolixizumab on IgG levels, which may aid in optimizing treatment regimens.
- Advanced studies emphasize the importance of FC receptor-targeting biologics in expanding treatment options for autoimmune disorders, promising effective therapies like rozanolixizumab that could enhance patient outcomes.
- Overall, recent findings support rozanolixizumab's potential as a groundbreaking treatment for autoimmune diseases, but further extensive trials are crucial to validate its long-term efficacy and safety.
Rystiggo (rozanolixizumab)
The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study.
London, UK
2 hours ago
1 Received
- Pathogenic IgG autoantibodies contribute to autoimmune diseases, and targeting the neonatal Fc receptor (FcRn) is a promising treatment approach.
- Rozanolixizumab, an anti-FcRn monoclonal antibody, was tested in cynomolgus monkeys, showing significant reductions in IgG levels without increasing infection risk.
- In a first-in-human study with healthy volunteers, rozanolixizumab demonstrated safety and tolerability while effectively reducing serum IgG concentrations, especially at higher doses.
$100 - $150
Hourly Rate
Erratum for the Research Article: "The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study" by P. Kiessling, R. Lledo-Garcia, S. Watanabe, G. Langdon, D. Tran, M. Bari, L. Christodoulou, E. Jones, G. Price, B. Smith, F. Brennan, I. White, S. Jolles.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration.
London, UK
2 hours ago
1 Received
- Rozanolixizumab (UCB7665) is a monoclonal antibody designed to target and reduce harmful IgG antibodies in autoimmune and alloimmune diseases by inhibiting the neonatal Fc receptor (FcRn).
- Studies show that this antibody effectively lowers plasma IgG levels in animal models (mice and cynomolgus monkeys) without affecting albumin levels and demonstrates a good safety profile during prolonged administration.
- Current research includes clinical trials for conditions like immune thrombocytopenia and myasthenia gravis, suggesting rozanolixizumab could be a promising new treatment option for these diseases.
$100 - $150
Hourly Rate
Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting the Effects of Anti-FcRn Therapy on the Disposition of Endogenous IgG in Humans.
London, UK
2 hours ago
1 Received
- - The study improved a pharmacokinetic model to predict how anti-FcRn agents affect natural IgG levels in humans, simulating various doses of monoclonal antibodies and immune globulin.
- - The model's predictions were compared with real data from the anti-FcRn agent rozanolixizumab, showing fairly accurate results for dose effects on IgG levels.
- - It suggests that anti-FcRn therapies might be more effective in healthy individuals than in those with higher IgG levels, indicating the model's potential in developing new dosing strategies for these therapies.
$100 - $150
Hourly Rate
Therapies Directed Against B-Cells and Downstream Effectors in Generalized Autoimmune Myasthenia Gravis: Current Status.
London, UK
2 hours ago
1 Received
- Myasthenia gravis is an autoimmune disease that causes muscle weakness due to autoantibodies targeting the neuromuscular junction, affecting various muscle-related proteins.
- The disease can be categorized based on factors like age of onset, weakness patterns, autoantibody types, and thymic issues, with most patients benefiting from immunosuppressive therapies, though 15% remain difficult to treat.
- Recent advancements in targeted B-cell therapies, including rituximab and eculizumab, have shown promise, though some studies have yielded mixed results, highlighting the need for further research and effective treatments.
$100 - $150
Hourly Rate
Next-generation Fc receptor-targeting biologics for autoimmune diseases.
London, UK
2 hours ago
1 Received
- * Three main drug development strategies are being explored: rFc multimers targeting Fcγ receptors, neonatal Fc receptor (FcRn)-targeting therapeutics, and Fc and FcγR-targeting therapeutics, with various candidate drugs undergoing clinical trials.
- * The most progressed candidates, efgartigimod and rozanolixizumab, show promise from phase 2 trials, but more long-term research is necessary to evaluate their efficacy, safety, and other factors for successful clinical use.
$100 - $150
Hourly Rate
Autoimmune thrombocytopenia: Current treatment options in adults with a focus on novel drugs.
London, UK
2 hours ago
1 Received
- - Immune thrombocytopenia (ITP) is an autoimmune disease that leads to decreased platelet levels and an increased risk of bleeding due to platelet destruction and reduced production.
- - First-line treatments include corticosteroids and intravenous immunoglobulins (IVIG), but if patients don’t respond, it's classified as refractory ITP, requiring second-line therapies such as rituximab and others.
- - Despite advances in treatment, some patients still do not respond, prompting research into new drugs, with recent studies showing promise for novel treatments, either alone or in combination with existing therapies.
$100 - $150
Hourly Rate
Current pharmacotherapeutic options for myasthenia gravis.
London, UK
2 hours ago
1 Received
- Recent advancements in immune-based therapies for myasthenia gravis show promise in improving patient outcomes, focusing on immunomodulation and complement inhibitors.
- The paper reviews traditional treatments and recent clinical trial evidence that highlights the effectiveness of these new immune therapies.
- While these exciting developments can enhance care, there is a concern about iatrogenic myasthenia gravis from some treatments, and future research aims to specifically prevent abnormal auto-antibody production.
$100 - $150
Hourly Rate
Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia.
London, UK
2 hours ago
1 Received
- Primary immune thrombocytopenia (ITP) is an autoimmune disorder causing low platelet counts, primarily driven by IgG antibodies, and this study explored the safety and effectiveness of rozanolixizumab, a new treatment targeting the neonatal Fc receptor to reduce IgG levels.
- In a multicenter trial with 66 patients, mild to moderate adverse events like headaches were reported in 77.3% of participants, but no serious side effects led to treatment discontinuation, confirming a favorable safety profile.
- Patients receiving rozanolixizumab experienced significant increases in platelet counts and reductions in IgG levels, with over 50% reaching clinically relevant platelet counts within days after treatment, promoting further development into phase 3 trials.
$100 - $150
Hourly Rate
Progress in the therapy of myasthenia gravis: getting closer to effective targeted immunotherapies.
London, UK
2 hours ago
1 Received
- This review updates the current strategies in immunomodulating and immunosuppressive therapies for myasthenia gravis and highlights new biologics that are either approved or on the verge of approval.
- Recent findings include that preoperative IVIg is unnecessary for stable myasthenia gravis patients, early Rituximab treatment can lead to sustained remission in many cases, and new biologics like Zilucoplan and Efgartigimod show promise in trials.
- The emerging therapies focus on targeted treatments aimed at specific immune pathways, indicating a positive shift towards effective management of myasthenia gravis and related neurological diseases.*
$100 - $150
Hourly Rate
Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial.
London, UK
2 hours ago
1 Received
- The study aimed to assess the effectiveness and safety of a new drug, rozanolixizumab, in treating generalized myasthenia gravis (gMG).
- In a clinical trial involving 43 patients, those receiving rozanolixizumab showed some improvements in myasthenia gravis symptoms, but the main measure (QMG score) did not show statistically significant results.
- Rozanolixizumab was generally well tolerated, with headaches being the most common side effect, and further research in a larger phase 3 trial is currently underway.
$100 - $150
Hourly Rate
The importance of FcRn in neuro-immunotherapies: From IgG catabolism, gene polymorphisms, IVIg dosing and efficiency to specific FcRn inhibitors.
London, UK
2 hours ago
1 Received
- The neonatal Fc receptor (FcRn) helps extend the lifespan of IgG antibodies by transporting them back to the cell surface to avoid degradation, but high levels from IVIg therapy can affect this process.
- Recent findings suggest that specific genetic variations (VNTR3/2 polymorphisms) in the FcRn gene may influence how long infused IgG remains in circulation and its overall effectiveness, particularly in certain autoimmune neurological diseases.
- The review also explores the potential of new monoclonal antibodies that inhibit FcRn in treating neurological conditions, signifying a shift in treatment strategies for patients who don't respond well to traditional IVIg therapies.
$100 - $150
Hourly Rate
Antiseizure Medication use in Gastric Bypass Patients and Other Post-Surgical Malabsorptive States.
London, UK
2 hours ago
1 Received
- Healthcare professionals are seeing more patients who have had bariatric surgery, posing challenges in medication management, especially with antiseizure medications (ASM) that have a narrow therapeutic window.
- * Patients with malabsorptive states from bariatric surgery may not absorb ASMs effectively, and there is limited research on how to adjust dosages for these patients.
- * Medications like levetiracetam and topiramate show better absorption post-surgery, while others like phenytoin and carbamazepine have reduced effectiveness; thus, a multidisciplinary team including pharmacists and neurologists is essential for proper management.
$100 - $150
Hourly Rate
[Reaserch Advances in the Treatment of Primary Immune Thrombocytopenia--Review].
London, UK
2 hours ago
1 Received
- Primary immune thrombocytopenia (ITP) is an autoimmune blood disorder where the body mistakenly targets and destroys platelets, leading to a risk of severe bleeding.
- The main treatment goal for ITP is to maintain a safe platelet count in patients, and recent FDA approvals include two new drugs: avatrombopag and fostamatinib.
- The review highlights current therapies for adult ITP and discusses the promising results of emerging treatments from clinical trials, such as rozanolixizumab and efgartigimod.
$100 - $150
Hourly Rate
Pharmacokinetic-pharmacodynamic modelling of the anti-FcRn monoclonal antibody rozanolixizumab: Translation from preclinical stages to the clinic.
London, UK
2 hours ago
1 Received
- Rozanolixizumab is a monoclonal antibody designed to enhance the removal of harmful IgG antibodies from the body by utilizing the lysosomal degradation pathway.
- The study aimed to create a pharmacokinetic/pharmacodynamic (PK/PD) model to understand how rozanolixizumab affects IgG levels in monkeys and to use this information for designing a first-in-human (FIH) clinical trial.
- Results showed that the model predictions for IgG reduction in humans matched well with actual data, especially at higher doses, but needed adjustments for lower doses based on new human data collected during the trial.
$100 - $150
Hourly Rate
Antibody Therapies in Autoimmune Encephalitis.
London, UK
2 hours ago
1 Received
- Autoimmune encephalitis (AE) is a group of disorders where the immune system mistakenly attacks the central nervous system, with a notable example being anti-NMDAR encephalitis, which involves neuropsychiatric symptoms.
- Treatment for AE primarily revolves around immunotherapy, starting with first-line therapies like steroids and plasma exchange, and moving to second-line options like alkylating agents or monoclonal antibodies (mAbs) if initial treatments fail.
- The chapter discusses various mAbs that target different aspects of the immune response in AE, including those directed at B cells, interleukin-6 (IL-6), the neonatal Fc receptor (FCRn), and components of the complement system.
$100 - $150
Hourly Rate
Therapeutic Monoclonal Antibody Therapies in Chronic Autoimmune Demyelinating Neuropathies.
London, UK
2 hours ago
1 Received
- Autoimmune diseases of the peripheral nervous system have primarily been treated with high-dose intravenous immunoglobulins (IVIg), which help by neutralizing harmful autoantibodies and modulating immune responses.
- Due to a shortage of IVIg, new treatments are emerging, including B cell depleting monoclonal antibodies like rituximab, particularly for conditions unresponsive to IVIg such as anti-MAG antibody neuropathy and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
- Other promising therapies include eculizumab, targeting complement activation, and FcRn blockers like efgartigimod, which is currently being investigated for CIDP after success in treating myasthenia gravis
$100 - $150
Hourly Rate
[Anti-NMDAR Encephalitis with Poor Recovery on Steroid Pulse and IVIg: Practical Approach to Intensive Immunotherapy].
London, UK
2 hours ago
1 Received
- Anti-N-methyl-D-aspartate receptor encephalitis (NMDARE) is an autoimmune condition that responds well to early, aggressive immunotherapy, guided by a recent treatment consensus.
- First-line therapy involves intravenous corticosteroids coupled with either IV immunoglobulins or plasma exchange, initiated as soon as possible after diagnosis, with options for escalation to second-line treatments like rituximab or IV cyclophosphamide if initial efforts are insufficient.
- Ongoing international clinical trials are exploring additional therapies, including rituximab and other drugs, to build stronger evidence for effective treatment strategies for autoimmune encephalitis.
$100 - $150
Hourly Rate
Pharmacotherapy of Generalized Myasthenia Gravis with Special Emphasis on Newer Biologicals.
London, UK
2 hours ago
1 Received
- - Myasthenia gravis (MG) is an autoimmune disorder affecting muscle function, with treatments traditionally relying on acetylcholinesterase inhibitors and corticosteroids, though newer therapies are emerging.
- - Conventional treatments can be slow to act and have significant side effects, whereas new biologic agents like eculizumab and efgartigimod offer faster, targeted immunotherapy with fewer adverse effects.
- - Ongoing research includes various agents targeting different mechanisms, but there are concerns like the risk of Neisseria meningitis with complement inhibitors, emphasizing the need for vaccinations.
$100 - $150
Hourly Rate
Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study.
London, UK
2 hours ago
1 Received
- Generalised myasthenia gravis is a serious autoimmune disease that currently lacks effective treatment options, leading researchers to explore rozanolixizumab as a new therapy.
- The MycarinG study was a rigorous, randomized, double-blind trial involving 300 patients across multiple continents, assessing the safety and effectiveness of different doses of rozanolixizumab compared to a placebo.
- The primary goal of the trial was to evaluate improvements in daily living activities, while also monitoring any adverse effects from the treatment over a 6-week period.
$100 - $150
Hourly Rate