A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

Start Date30 May 2022

Sponsor / Collaborator

Dimerix Bioscience Pty Ltd.

ACTRN12622000066785 / RecruitingPhase 3

A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB)

Start Date30 May 2022

Sponsor / Collaborator

Dimerix Bioscience Pty Ltd.

NCT05122182 / TerminatedPhase 2IIT

An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19

CLARITY 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a CCR2 antagonist, and candesartan, an ARB, in patients hospitalised with COVID-19 disease.

Start Date07 Jan 2022

Sponsor / Collaborator

The University of Sydney

[+1]

100 Clinical Results associated with Repagermanium

100 Translational Medicine associated with Repagermanium

100 Patents (Medical) associated with Repagermanium

Literatures (Medical) associated with Repagermanium

01 Oct 2024·BMJ Open

Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial

Article

Author: Jardine, Meg ; Pollock, Carol ; Rathore, Vinay ; Jones, Cheryl ; Fox, Gregory ; Bangi, Ashpak ; Snelling, Thomas L ; Bassi, Abhinav ; Jones, Mark ; Jain, Manish Kumar ; Kotwal, Sradha ; Faridah Syed Omar, Sharifah ; O'Hara, Daniel Vincent ; D'Cruz, Sanjay ; Totterdell, James ; Burrell, Louise ; Jha, Vivekanand ; Wilcox, Arlen

Objective:

To determine whether a chemokine receptor type 2 antagonist, DMX-200 (repagermanium), in combination with an angiotensin receptor blocker, candesartan, improves clinical outcomes in people with COVID-19.

Design:

Prospective, multicentre, double-blind, placebo-controlled trial.

Setting:

Ten acute care hospitals in India.

Participants:

Adults <65 years old intended for hospital admission with moderate/severe COVID-19 disease (respiratory rate ≥24 breaths per minute or oxygen saturation ≤93% on room air).

Intervention:

DMX-200 120 mg two times per day, or placebo, on background of titratable candesartan commencing at 4 mg two times per day, for 28 days.

Main outcome measures:

The primary endpoint was COVID-19 disease severity on a modified WHO Clinical Progression Scale (WHO scale) on day 14. Secondary outcomes included the WHO scale at days 28, 60, 90 and 180; intensive care unit (ICU) admission, respiratory failure or death within 28 days; length of hospitalisation; and requirement for ventilatory support or dialysis.

Results:

Between December 2021 and August 2022, 518 people were screened, with 49 randomised to DMX-200 or placebo on a background of candesartan. The study was terminated early due to recruitment barriers, including an external requirement to restrict enrolment to adults <65 years old, contributing to a 91% screen failure rate. The median WHO Clinical Progression Scale (WHO scale) score at day 14 for both groups was 1 (IQR 1–1), indicating most participants were discharged with no limitations on activities by this time. Formal comparison was not performed due to the small sample size. One participant receiving DMX-200 died of COVID-19 disease progression. No participants required ICU admission, ventilation or dialysis. Median length of hospitalisation in both groups was 6 days (IQR 6–7 days). WHO scale scores were similar at 28, 60, 90 and 180 days.

Conclusion:

Due to recruitment barriers, the study was unable to determine whether DMX-200 improves clinical outcomes in people with COVID-19.

Trial registration number:

ClinicalTrials.govNCT05122182.

11 Apr 2023·JAMA

Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support–Free Days in Patients Hospitalized With COVID-19

Article

IMPORTANCE:

Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.

Objective:

To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.

DESIGN, SETTING, AND PARTICIPANTS:

In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).

INTERVENTIONS:

Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days.

MAIN OUTCOMES AND MEASURES:

The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes.

RESULTS:

On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively).

CONCLUSIONS AND RELEVANCE:

In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT02735707

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Investigation of Strategies to Block Downstream Effectors of AT1R-Mediated Signalling to Prevent Aneurysm Formation in Marfan Syndrome

Article

Author: Verstraeten, Aline ; Meester, Josephina ; Loeys, Bart ; Schippers, Jolien ; Van Kimmenade, Roland R. J. ; Peeters, Silke ; Buccioli, Lucia ; Valdivia Callejon, Irene ; Danser, A. H. Jan ; Luyckx, Ilse ; Bastianen, Jarl

Cardiovascular outcome in Marfan syndrome (MFS) patients most prominently depends on aortic aneurysm progression with subsequent aortic dissection. Angiotensin II receptor blockers (ARBs) prevent aneurysm formation in MFS mouse models. In patients, ARBs only slow down aortic dilation. Downstream signalling from the angiotensin II type 1 receptor (AT1R) is mediated by G proteins and β-arrestin recruitment. AT1R also interacts with the monocyte chemoattractant protein-1 (MCP-1) receptor, resulting in inflammation. In this study, we explore the targeting of β-arrestin signalling in MFS mice by administering TRV027. Furthermore, because high doses of the ARB losartan, which has been proven beneficial in MFS, cannot be achieved in humans, we investigate a potential additive effect by combining lower concentrations of losartan (25 mg/kg/day and 5 mg/kg/day) with barbadin, a β-arrestin blocker, and DMX20, a C-C chemokine receptor type 2 (CCR2) blocker. A high dose of losartan (50 mg/kg/day) slowed down aneurysm progression compared to untreated MFS mice (1.73 ± 0.12 vs. 1.96 ± 0.08 mm, p = 0.0033). TRV027, the combination of barbadin with losartan (25 mg/kg/day), and DMX-200 (90 mg/kg/day) with a low dose of losartan (5 mg/kg/day) did not show a significant beneficial effect. Our results confirm that while losartan effectively halts aneurysm formation in Fbn1C1041G/+ MFS mice, neither TRV027 alone nor any of the other compounds combined with lower doses of losartan demonstrate a notable impact on aneurysm advancement. It appears that complete blockade of AT1R function, achieved by administrating a high dosage of losartan, may be necessary for inhibiting aneurysm progression in MFS.

News (Medical) associated with Repagermanium

30 Mar 2023

·www.prnewswire.com

Extremely Robust Acute Respiratory Distress Syndrome Pipeline Featuring 100+ Companies Expected to Change the Pace of the ARDS Treatment | DelveInsight

The rise in the incidence of ARDS stimulates the research and development of the drug, as it is likely to provide an appropriate environment for newer products to be profitable. Companies across the globe have shifted their focus toward the treatment of ARDS. The increase in the incidence will potentiate the treatment market for ARDS. Treatment goals, such as "permissive atelectasis", "permissive hypercapnia", and even "permissive hypoxemia", have been introduced as targets of ventilatory support. Together with the increased knowledge and understanding of how mechanical ventilation can harm the lungs, a major effort has been put into preventing or shortening the use of mechanical ventilation as much as possible and using settings that are considered to be "lung-protective." Several other supportive care options are available, but they all do not withstand the current needs of patients for this indication. LAS VEGAS, March 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Respiratory Distress Syndrome Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute respiratory distress syndrome therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute respiratory distress syndrome pipeline domain. Key Takeaways from the Acute Respiratory Distress Syndrome Pipeline Report DelveInsight's acute respiratory distress syndrome pipeline report depicts a robust space with 100+ active players working to develop 105+ pipeline therapies for acute respiratory distress syndrome treatment. Key acute respiratory distress syndrome companies such as Biocon, NRx Pharmaceuticals, Humanigen, Mesoblast, Sage Therapeutics, Evgen Pharma, Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Healthcare, Foresee Pharmaceuticals, BioMarck Pharmaceuticals, Boehringer Ingelheim, Biohaven Pharmaceuticals, Biophytis, NovImmune SA, Constant Therapeutics, Windtree Therapeutics, Acticor Biotech, Direct Biologics, F4 Pharma, Apeiron Biologics, Trevena, Synact Pharma, Pluristem Therapeutics, UCB Pharma, Chiesi Farmaceutici, and others are evaluating new acute respiratory distress syndrome drugs to improve the treatment landscape. Promising acute respiratory distress syndrome pipeline therapies in various stages of development include Itolizumab, ZYESAMI, Lenzilumab, Remestemcel-L, Brexanolone, SFX-01, DMX-200, Tradipitant, Siltuximab, VERU 111, BIO 11006, FP025, Alteplase, Sarconeos Zavegepant, EB 05, USB 002, Sinapultide, Glenzocimab, DB 001, FX06, APN01, TRV 027, AP1189, PLX PAD, Zilucoplan, CHF5633, and others. In March 2023, Tetra Bio-Pharma received up to $150,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support a research and development project to enable the development of its ARDS-003 oral formulation. Specifically, the funds will be used to optimize the formulation and perform animal non-GLP Pharmacokinetic Studies. In February 2021, Avid Bioservices and Humanigen announced that they had entered into a manufacturing services agreement to expand production capacity for lenzilumab. Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid would initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen's regulatory and potential commercial activities. Request a sample and discover the recent advances in ARDS drug treatment @ Acute Respiratory Distress Syndrome Pipeline Report The acute respiratory distress syndrome pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute respiratory distress syndrome drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute respiratory distress syndrome clinical trial landscape. Acute Respiratory Distress Syndrome Overview Acute respiratory distress syndrome (ARDS) is a rapidly progressing condition that primarily affects the critically ill. The most serious complication of ARDS is fluid leaking into the lungs, making breathing difficult or impossible. The ARDS causes are classified as direct or indirect lung injuries. Direct lung injuries include pneumonia, aspiration, trauma, and others. Examples of indirect lung injuries include pancreatic inflammation, severe infection (also known as sepsis), blood transfusions, burns, and pharmaceutical responses. ARDS symptoms include shortness of breath, coughing, and fever; in some cases, high heart rates and rapid breathing have also been observed. Patients with ARDS may experience chest pain, especially during inhalation, and some may develop blue nails and lips due to drastically reduced oxygen levels in the blood. Mechanical ventilation, stress ulcer and venous thromboembolism prevention, nutritional support, and underlying damage therapy are all part of the acute respiratory distress syndrome treatment. Find out more about drugs for ARDS @ New Acute Respiratory Distress Syndrome Drugs A snapshot of the Acute Respiratory Distress Syndrome Pipeline Drugs mentioned in the report: Learn more about the emerging acute respiratory distress syndrome pipeline therapies @ ARDS Clinical Trials Acute Respiratory Distress Syndrome Therapeutics Assessment The acute respiratory distress syndrome pipeline report proffers an integral view of acute respiratory distress syndrome emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Respiratory Distress Syndrome Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Androgen receptor antagonists, Hedgehog protein modulators, Histone deacetylase inhibitors, NF E2 related factor 2 stimulants, Wnt signalling pathway modulators, Cell replacements, Toll-like receptor 4 antagonists, Fibrinolytic agents, Plasminogen activator stimulants, Plasminogen activators, Myristoylated alanine-rich C kinase substrate inhibitors, Cell membrane permeability enhancers, Sodium channel agonists Key Acute Respiratory Distress Syndrome Companies: Biocon, NRx Pharmaceuticals, Humanigen, Mesoblast, Sage Therapeutics, Evgen Pharma, Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Healthcare, Foresee Pharmaceuticals, BioMarck Pharmaceuticals, Boehringer Ingelheim, Biohaven Pharmaceuticals, Biophytis, NovImmune SA, Constant Therapeutics, Windtree Therapeutics, Acticor Biotech, Direct Biologics, F4 Pharma, Apeiron Biologics, Trevena, Synact Pharma, Pluristem Therapeutics, UCB Pharma, Chiesi Farmaceutici, and others. Key Acute Respiratory Distress Syndrome Pipeline Therapies: Itolizumab, ZYESAMI, Lenzilumab, Remestemcel-L, Brexanolone, SFX-01, DMX-200, Tradipitant, Siltuximab, VERU 111, BIO 11006, FP025, Alteplase, Sarconeos Zavegepant, EB 05, USB 002, Sinapultide, Glenzocimab, DB 001, FX06, APN01, TRV 027, AP1189, PLX PAD, Zilucoplan, CHF5633, and others. Dive deep into rich insights for new drugs for ARDS treatment; visit @ Acute Respiratory Distress Syndrome Medications Table of Contents For further information on the acute respiratory distress syndrome pipeline therapeutics, reach out @ Acute Respiratory Distress Syndrome Drug Treatment Related Reports Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key acute respiratory distress syndrome companies, including Cellular Biomedicine Group, Baylx, Histocell, Cartesian Therapeutics, Cynata Therapeutics, Immunovative Therapies, Orbsen Therapeutics, Celularity, Bonus BioGroup, Diffusion Pharmaceuticals, among others. Respiratory Distress Syndrome Market Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key respiratory distress syndrome companies, including Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Inc., BioMarck Pharmaceuticals, CTI BioPharma, Athersys, Foresee Pharmaceuticals, Boehringer Ingelheim, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key chronic obstructive pulmonary disease companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma, among others. Asthma Pipeline Asthma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including GSK, AstraZeneca, Teva Pharmaceuticals, among others. Severe Asthma Pipeline Severe Asthma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key severe asthma companies, including AstraZeneca, Novartis, Sanofi, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Promising Therapies in the ARDS Market Rising Acute Respiratory Distress Syndrome Prevalence ARDS Market Outlook Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

22 Sep 2022

·www.prnewswire.com

Despite Amplified Use of SGLT2 Inhibitors for Glomerular Diseases, EU and US Nephrologists Express a Continued Strong Desire for New Treatment Options for FSGS Patients, Spherix Reports

EXTON, PA., Sept. 21, 2022 /PRNewswire/ -- Focal segmental glomerulosclerosis (FSGS) is one of the leading causes of nephrotic syndrome across the world and is considered the most common glomerular cause of end-stage renal disease (ESRD).1 Spherix has been tracking the evolution of the FSGS market since 2018 to keep a pulse on how nephrologists are treating patients and the perceived potential for products as they make their way through development. Over the past few months, Spherix has released two reports revealing insights from both US-based and EU5-based nephrologists as a part of its Market Dynamix™: Focal Segmental Glomerulosclerosis (FSGS) research services. Insights were gathered from qualitative and quantitative research conducted with 100 nephrologists across the United States and more than 250 nephrologists from France, Germany, Italy, Spain, and the UK. These services provide insights into perceptions of unmet needs, gaps in care, and evolving treatment paradigms. Of note, Spherix experts found that while most FSGS patients are still confirmed via kidney biopsies, nephrologists are becoming increasingly likely to use genetic testing for diagnosis. As understanding of genetic causes of disease advances (including the role of APOL-1), nephrologists are optimistic for more targeted and effective therapies. Other findings of the US- and EU5-based research reveal that nephrologists across both geographies strongly agree that reducing proteinuria is an important treatment goal for their FSGS patients, as they believe proteinuria is a key contributor to FSGS progression. However, key regional differences emerge when nephrologists consider which proteinuria levels may trigger use of steroids, with some physicians much more aggressive and others more conservative. A major shift seen over the past year is the increasing use of SGLT2 inhibitors (including AstraZeneca's Farxiga/Forxiga, Boehringer Ingelheim/Lilly's Jardiance, and Janssen's Invokana) in glomerular disease patients. Nephrologists in the EU5 and the US are using these products more often in their FSGS and IgA nephropathy patients in particular, especially those with lingering proteinuria after initial ACE inhibitor and/or ARB treatment. In fact, reported use of SGLT2 inhibitors in primary FSGS patients more than doubled year-over-year in both regions captured in these studies, with expectations for continued growth. A growing number of nephrologists also indicate they will start patients on an ACEi/ARB alongside an SGLT2 inhibitor as they embrace this new mechanism of action. Despite the addition of SGLT2 inhibitors to the armamentarium, nephrologists across the EU5 and the US continue to rate FSGS patients overall as highly challenging to manage and believe there is an extremely high unmet need for new treatment options. To gauge pipeline product potential, Spherix assessed awareness, familiarity, desire to have approved, likelihood to prescribe, and estimated patient candidacy for the following assets: Abatacept (BMS) Atrasentan (Chinook) Bardoxolone methyl (Reata) Blesumab, ASKP1240 (Astellas/Kyowa Kirin) DMX-200 (Dimerix) GFB-887 (Goldfinch Bio) PF-06730512 (Pfizer) Sparsentan (Travere, commercialized by Vifor in the EU) VAR 200 (ZyVersa) VX-147 (Vertex) Spherix has in-depth expertise across the glomerular disease market (including FSGS, IgA nephropathy, Alport syndrome, C3G, membranous nephropathy, and more). The company has been a leader in tracking many of these markets for years, covering physician perspectives, treatment patterns, and pipeline assessments. This coverage includes in-depth interviews with key opinion leaders (KOLs) and "in-the-trenches" physicians. More research is also available through in-depth US-based chart audits as part of the RealWorld Dynamix™: FSGS (US) service. Additionally, Spherix will soon release its first IgA nephropathy study from the Japanese market. About Market Dynamix™ Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years, highlighting market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About RealWorld Dynamix™ RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets. All company, brand or product names in this document are trademarks of their respective holders.

100 Deals associated with Repagermanium

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulosclerosis, Focal Segmental	Phase 3	US	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	AR	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	AU	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	BR	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	DK	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	FR	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	HK	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	NZ	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	ES	Dimerix Bioscience Pty Ltd.	30 May 2022
Glomerulosclerosis, Focal Segmental	Phase 3	TW	Dimerix Bioscience Pty Ltd.	30 May 2022

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