Double Blind, Phase III Randomized,Safety and Efficacy Non-inferiority Trial to Evaluate Two Short Benznidazole Regimens for the Treatment of Adults in the Chronic Phase of Chagas Disease in Its Indeterminate and Mild Cardiac Forms in Bolivia and Colombia

Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects.
The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events.

Start Date01 May 2024

Sponsor / Collaborator

Evandro Chagas Institute

NCT05523596 / RecruitingPhase 1

A Phase 1 Non-Randomized Open Label Study of ICM20

A Phase 1 Non-Randomized Open Label Study of Oral ICM20

Start Date20 Dec 2022

Sponsor / Collaborator

Ic Medtech Corp.

NCT04897516 / RecruitingPhase 3

Phase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease

Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.

Start Date28 Jul 2021

Sponsor / Collaborator

Laboratorio Elea Phoenix SA

[+1]

100 Clinical Results associated with Benznidazole

100 Translational Medicine associated with Benznidazole

100 Patents (Medical) associated with Benznidazole

1,537

Literatures (Medical) associated with Benznidazole

01 Mar 2024·International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

Mother‐to‐child Chagas disease transmission: The challenge of detection and prevention in areas without the risk of vectorial transmission

Review

Author: Palacios Gil-Antuñano, Santiago ; Cancelo-Hidalgo, Maria Jesus ; Abril, Marcelo ; Gold, Silvia ; Flores-Chávez, Maria ; Segovia Hernández, Manuel ; Pelayo-Delgado, Irene

Abstract:

Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Although it is endemic in many Latin American (LA) countries, mother‐to‐child transmission has caused it to expand to other countries and continents. In places where vector transmission is controlled or absent, the epidemiological importance of T. cruzi transmission of the infected mother to her child during pregnancy or childbirth (i.e., perinatal CD) increases. In countries where CD is not endemic, CD screening should be performed in pregnant or fertile women who are native to LA countries or whose mothers are native to LA countries. Diagnosis is established by detecting anti–T. cruzi IgG antibodies in a serum or plasma sample. Antiparasitic treatment cannot be offered during pregnancy, and since the majority of infected newborns are asymptomatic at birth, a diagnosis is made by direct observation or concentration (microhematocrit) or by using molecular testing techniques. Once the infected child receives a diagnosis, it is essential to offer treatment (benznidazole/nifurtimox) as soon as possible, with good tolerance and effectiveness in the first year of life. Even if the diagnosis is negative at birth, the newborn must be followed up for at least the first 9 months of life.

22 Feb 2024·Journal of medicinal chemistryQ1 · MEDICINE

Design and Synthesis of Novel 3-Nitro-1H-1,2,4-triazole-1,2,3-triazole-1,4-disubstituted Analogs as Promising Antitrypanosomatid Agents: Evaluation of In Vitro Activity against Chagas Disease and Leishmaniasis

Q1 · MEDICINE

Article

Author: Arruda, Carla C P ; Piranda, Eliane M ; Paredes-Gamero, Edgar J ; Batista, Jaqueline C Z ; Silva, Fernanda ; Pelizaro, Bruno I ; Luccas, Pedro H ; Portapilla, Gisele B ; Baroni, Adriano C M ; Galvão, Fernanda ; Pessatto, Lucas R ; Silva, Denise B ; Cardoso, Iara A ; Cassemiro, Nadla S ; Oliveira, Kelly M P ; Shiguemoto, Cristiane Y K ; Lopes, Norberto P ; de Albuquerque, Sergio ; Nonato, M Cristina ; das Neves, Amarith R ; Carvalho, Diego B

A series of 28 compounds, 3-nitro-1H-1,2,4-triazole, were synthesized by click-chemistry with diverse substitution patterns using medicinal chemistry approaches, such as bioisosterism, Craig-plot, and the Topliss set with excellent yields. Overall, the analogs demonstrated relevant in vitro antitrypanosomatid activity. Analog 15g (R₁ = 4-OCF₃-Ph, IC₅₀ = 0.09 μM, SI = >555.5) exhibited an outstanding antichagasic activity (Trypanosoma cruzi, Tulahuen LacZ strain) 68-fold more active than benznidazole (BZN, IC₅₀ = 6.15 μM, SI = >8.13) with relevant selectivity index, and suitable LipE = 5.31. 15g was considered an appropriate substrate for the type I nitro reductases (TcNTR I), contributing to a likely potential mechanism of action for antichagasic activity. Finally, 15g showed nonmutagenic potential against Salmonella typhimurium strains (TA98, TA100, and TA102). Therefore, 3-nitro-1H-1,2,4-triazole 15g is a promising antitrypanosomatid candidate for in vivo studies.

01 Feb 2024·Archives of medical research

Repositioning FDA-Approved Drug Against Chagas Disease and Cutaneous Leishmaniosis by Structure-Based Virtual Screening

Article

Author: Juarez-Saldivar, Alfredo ; Sanchez-Torres, Luvia ; Horta-Montaño, Vanessa ; Rivera, Gildardo ; Corral-Ruiz, Gerardo ; Nogueda-Torres, Benjamín ; Gómez-Escobedo, Rogelio ; Chacón-Vargas, Karla Fabiola ; Vazquez-Jimenez, Lenci K

BACKGROUND:

Chagas disease and cutaneous leishmaniasis, two parasitic diseases caused by Trypanosoma cruzi (T. cruzi) and Leishmania mexicana (L. mexicana), respectively, have a major global impact. Current pharmacological treatments for these diseases are limited and can cause severe side effects; thus, there is a need for new antiprotozoal drugs.

METHODS:

Using molecular docking, this work describes a structure-based virtual screening of an FDA-approved drug library against Trypanosoma cruzi and Leishmania mexicana glycolytic enzyme triosephosphate isomerase (TIM), which is highly conserved in these parasites. The selected compounds with potential dual inhibitory activity were tested in vitro to confirm their biological activity.

RESULTS:

The study showed that five compounds: nilotinib, chlorhexidine, protriptyline, cyproheptadine, and montelukast, were more active against T. cruzi, than the reference drugs, nifurtimox and benznidazole while chlorhexidine and protriptyline were the most active against L. mexicana.

CONCLUSIONS:

The analysis of these compounds and their structural characteristics may provide the basis for the development of new antiprotozoal agents.

News (Medical) associated with Benznidazole

16 Apr 2024

·www.prnewswire.com

Health Alert: Chagas Disease, Also Known as American Trypanosomiasis, Poses Life-Threatening Risk from Trypanosoma Cruzi Parasite: BCC Research LLC

Chagas disease, which is also known as American trypanosomiasis, occurs when you get infected with a small parasite called Trypanosoma cruzi. A doctor named Carlos RJ Chagas from Brazil discovered this parasite and how it causes illness in people way back in 1909. BOSTON, April 16, 2024 /PRNewswire/ -- The new research gives a complete picture of the Chagas Disease: American trypanosomiasis market. It looks at trends in the CD market, including how common it is in different regions, and talks about what's happening in the market right now. The report also looks closely at the competition between different treatments. It focuses on treatments available across Latin America. Because many people with Chagas Disease don't have enough money to buy medicine, there isn't much demand for these products. That's why pharmaceutical companies aren't putting a lot of effort into creating new treatments for Chagas disease now. Key Facts to Know About Chagas Disease: A Quick Overview About 6-7 million people, mostly in Latin America, have a bug bite disease called Chagas disease. It can be passed on by bugs, eating unsafe food, getting blood or organs from infected people, passing it from mother to baby, or accidents in labs. If treated early, Chagas disease caused by Trypanosoma cruzi can be cured. Treatment can also help stop the disease from getting worse and prevent passing it from mother to baby. Some people with long-term Chagas disease might have heart problems, and others might have stomach or brain issues. They might need special treatment for these. Ways to stop Chagas disease include controlling bugs in Latin America, checking blood before giv ing it to someone, and testing and treating girls, women who can have babies, newborns, and brothers and sisters of infected moms who haven't had treatment before. The Transmission of Chagas Disease in the American Market: Key Insights In Latin America, Chagas disease mostly spreads from poop or pee of blood-sucking bugs called kissing bugs. These bugs hide in cracks in houses and come out at night to feed on blood. When they bite, they often do it on the face. If someone scratches the bite and gets the poop or pee in their body, they can get infected with the parasite. T. cruzi can also be transmitted by: If you eat or drink something with T. cruzi in it, like food or drinks with poop or pee from infected bugs or opossums, you can get sick. This often causes outbreaks where people get very sick, and some even die. When a mom who has Chagas disease gives birth, she can pass it on to her baby. Getting blood or something made from blood from someone who has Chagas disease can also give you the disease. Signs and symptoms Chagas disease has two phases. In the first phase, which lasts about 2 months, a lot of parasites are in the blood, but most people don't have any symptoms or just feel a little unwell. Sometimes, people might see a spot on their skin or swelling around one eye. They could also have fever, headache, swollen glands, pale skin, muscle pain, trouble breathing, or pain in the belly or chest. In the second phase, the parasites hide in the heart and stomach muscles. After one to three decades, about a third of patients have heart problems, and about one in ten have stomach issues. Over time, the infection can damage the nerves and heart muscles, causing heart problems, irregular heartbeats, heart failure, or sudden death. Chagas Disease Treatment in the American Market Chagas disease can be treated with medicines like benznidazole or nifurtimox to kill the parasite. These drugs work best if given early, especially during the first phase of the disease. Treatment can also help prevent the disease from getting worse. However, treatment can have side effects, and it's not recommended for pregnant women or people with certain health conditions. In some cases, additional treatment may be needed for heart, digestive, or nerve problems caused by the disease. Control and Prevention In different places, the World Health Organization WHO (World Health Organisation) suggests various ways to prevent and control Chagas disease: Using bug sprays inside homes and nearby areas to kill insects and keep them away. Fixing up homes and keeping them clean to stop bugs from getting in. Using bed nets and practicing good hygiene when handling food, during transport, and storage to prevent infection. Creating easy-to-understand information and education programs for different situations and people about how to prevent the disease and use surveillance tools. Checking blood donors to make sure they don't have the disease. Checking organ, tissue, or cell donors and recipients to make sure they don't have the disease Here are the top 5 key companies in the Chagas Disease (American trypanosomiasis) market along with brief descriptions: Bayer AG: A multinational pharmaceutical company known for its commitment to global health initiatives, including research and development of treatments for neglected tropical diseases like Chagas Disease. Sanofi S.A.: A leading pharmaceutical company with a focus on innovative treatments for various diseases, including neglected tropical diseases such as Chagas Disease. GlaxoSmithKline plc: A global healthcare company dedicated to developing vaccines and treatments for infectious diseases, including Chagas Disease. Novartis AG: A pharmaceutical company known for its research and development efforts in addressing unmet medical needs, including the development of therapies for neglected tropical diseases like Chagas Disease. Merck & Co., Inc.: A leading global healthcare company committed to developing innovative treatments and vaccines for a wide range of diseases, including Chagas Disease. Directly Purchase a copy of the report with BCC Research. For further information or to make a purchase, please get in touch with [email protected]. About BCC Research BCC Research provides objective, unbiased measurement and assessment of market opportunities with detailed market research reports. Our experienced industry analysts' goal is to help you make informed business decisions, free of noise and hype. Contact Us Corporate HQ: 50 Milk St. Ste 16, Boston, MA 02109, USA Email: [email protected], Phone: +1 781-489-7301 For media inquiries, email [email protected] or visit our media page for access to our market research library. Data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher. Logo: SOURCE BCC Research LLC

Vaccine

12 Feb 2024

·www.fiercebiotech.com

Biotech bankruptcies hit 10-year peak in 2023

In terms of biotech bankruptcies, the new year is starting off bleak. In the first few days of 2024 alone, Humanigen and Athersys both filed for bankruptcy. More biotech companies filed for bankruptcy in 2023 than any year since 2010, underscoring a brutal year defined by layoffs, company closures and pipeline reprioritizations, according to data from S&P Global Market Intelligence. 2023 eclipsed all other years by far, with 18 companies filing for protection compared to eight in 2022, which had previously held the record as the highest bankruptcy year. https://public.flourish.studio/visualisation/16736139/ The year kicked off with Sorrento Therapeutics filing Chapter 11 amid a legal battle with billionaire Patrick Soon-Shiong and his immunotherapy biotech NantCell. The company had $235 million in debt and had run out of options. Sorrento had been developing a generic rival to Bristol Myers Squibb’s Abraxane, which was the subject of the dispute with Soon-Shiong. As of November 2023, Sorrento had laid off its chief financial officer in the final step in the closure process, according to a Securities and Exchange Commission document. For Infinity Pharmaceuticals, an unsuccessful merger with MEI Pharma was the straw that broke the camel’s back. The cancer-focused biotech filed for Chapter 11 bankruptcy on Sept. 29, a move that followed a 75% workforce reduction in July. Infinity had looked for a strategic transaction to keep running trials for eganelisib, a midstage asset being assessed in multiple indications, including urothelial cancer and solid tumors. MEI Pharma appeared to offer the saving Infinity sought until MEI shareholders’ sunk the deal, with 51% of voters opposed to the transaction. OncoSec Medical, which filed in June, was forced to wrap up after a pivotal trial of an interleukin 12-encoding plasmid in combination with Merck & Co.’s Keytruda failed to meet the bar for success in objective response rate. The phase 2b trial was testing the med, called TAVO-EP, in patients with unresectable or metastatic melanoma who had progressed after treatment with an anti-PD-1 checkpoint inhibitor. The company filed for bankruptcy after defaulting on a $2 million loan. https://public.flourish.studio/visualisation/16735813/ Back to court In terms of biotech bankruptcies, the new year is starting off bleak. In the first few days of 2024 alone, Humanigen and Athersys both filed for bankruptcy. The move comes as no surprise for Humanigen, a monoclonal-antibody-focused biotech that had been considering bankruptcy since last summer after talks of a potential reverse merger fell through. The company was on its last leg, with only $3.1 million in the bank last March after its anti-human GM-CSF mAb failed to improve outcomes in hospitalized COVID-19 patients in 2022. This is not the first time Humanigen has gone to the bankruptcy courts. The company, then named KaloBios Pharmaceuticals, also filed in 2015 but managed to reorganize and survive the struggle, according to the S&P data. The company emerged from bankruptcy the following year, thanks to a $14 million equity financing that helped recapitalize the business. Humanigen also picked up rights to a rare disease treatment called benznidazole. The biotech’s name changed to Humanigen in August 2017. But financial troubles again hit the newly named company, forcing the offloading of benznidazole in December 2017 as part of an agreement to exchange loan obligations for equity. Humanigen shifted from rare diseases to immunotherapy and oncology and moved lenzilumab to the center of its pipeline. Lenzilumab never quite found its footing in the clinic, with Humanigen testing it in cancer, COVID-19, graft-versus-host disease and others. A second therapy, the EphA-3-targeted monoclonal antibody ifabotuzumab, was also in development as recently as August 2023. That August pipeline update was the last from Humanigen, and, in January, bankruptcy papers (PDF) were filed. The company now plans to sell off its assets in a bidding process. But before filing the bankruptcy work, Humanigen sold off its biopharma business to Taran Therapeutics, meaning the therapies will go on via a stalking horse bid. Taran picked up a portfolio of monoclonal antibodies, including lenzilumab, ifabotuzumab and HGEN005, for $20 million. The writing was also on the wall for Athersys after the stem cell therapy company suffered a series of clinical setbacks. Ultimately, disappointing phase 3 data for an ischemic stroke cell therapy triggered the biotech to sell off all assets and file for bankruptcy Jan. 5. The healthcare sector as a whole has kicked off the year in third place among bankruptcy filings by sector, according to S&P, behind industrials and consumer discretionary. While the pace of bankruptcies across all sectors declined to start the year, S&P noted that companies are still facing relatively high interest rates and a challenging labor market. Editor's note: Chart data sourced from S&P Global Market Intelligence. Graphics by Gabrielle Masson.

Phase 2ImmunotherapyPhase 3AcquisitionCell Therapy

08 Feb 2024

·www.prnewswire.com

Chagas Disease (T. cruzi Infection) Epidemiological Review and Competitive Landscape Analysis 2024-2028

DUBLIN , Feb. 8, 2024 /PRNewswire/ -- The "Chagas Disease: American trypanosomiasis Market" report has been added to ResearchAndMarkets.com's offering. The protozoan Trypanosoma cruzi is the cause of Chagas disease (CD), also known as American trypanosomiasis, a chronic, systemic, parasitic illness with substantial risk factors associated with low socioeconomic status. It is believed that Chagas sickness is a neglected tropical illness. It is widespread throughout 21 American countries, but it can spread to non-endemic nations worldwide through the movement of infected individuals. The effects of CD extend beyond Latin American rural communities where vector-borne transmission - diseases spread by insects - occurs. The epidemiology and geographic distribution of CD have changed due to significant population shifts from rural to urban areas in Latin America and other parts of the world. Control measures should concentrate on preventing transmission from organ transplants, blood transfusions and mother-to-child (congenital) transmission in the U.S. and other areas where CD is currently present but is not endemic. Treatment for T. cruzi infection can begin as soon as the infection occurs. Antiparasitic therapy may stop or slow the progression of chronic illnesses in infected people, as well as stop infections from spreading from mother to child. Two therapeutic modalities have the potential to save lives: Antiparasitic medication, which eliminates the parasite. Symptomatic therapy, which is intended to control infection-related symptoms and indicators. Treatment with antiparasitic drugs is most beneficial early in the course of infection, albeit not exclusively for acute or critical cases. There are two kinds of treatments offered in the U.S. Benznidazole is available commercially and has been licensed by the FDA for use in children ages 2 to 12. Pharmacies can buy LAMPIT (nifurtimox) commercially from several medication wholesalers. It is FDA-approved for treating children under the age of 18. Healthcare providers can consult with Centers for Disease Control and Prevention (CDC) personnel regarding patient care, and for the most part, therapy does not require hospitalization. The research report provides a thorough overview of the Chagas Disease market. This report analyzes CD market trends with epidemiological and regional markets, highlights the current market and offers a detailed competitive environment analysis. The scope of this report covers treatment throughout Latin America. The Report Includes An overview of the global chagas disease (T. cruzi infection) market Analyses of the global market trends, with historical market revenue from 2021 to 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028 Estimate of the market size and revenue forecast for global chagas disease market, and corresponding market share analysis based on the product type, treatment, and region Overview of the significant driving trends and challenges that affect the global market and its vendor landscape Review of the epidemiology of chagas disease and potential of key marketed drugs and recent approvals Discussion of sustainability trends and factors in the chagas disease market, with emphasis on consumer attitudes, ESG score analysis, future of ESG, case study, and the ESG practices followed Analysis of the competitive intelligence based on recent developments, key financials and segmental revenues, and product launch strategies Detailed profiles of leading market participants Bayer and Insud Pharma, providing a descriptive overview of their respective businesses Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview History Trypanosoma Cruzi Vector and T. cruzi Transmission Routes Clinical Forms Future Perspectives Novel Drugs Chapter 4 Chagas Disease by Drugs Benznidazole Toxicity of Benznidazole Nifurtimox Toxicity of Nifurtimox Chapter 5 Chagas Disease by Diagnosis Serology (Antibody Detection) Molecular Testing Chapter 6 Competitive Landscape Chapter 7 Company Profiles Bayer Insud Pharma For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Drug Approval

100 Deals associated with Benznidazole

External Link

KEGG	Wiki	ATC	Drug Bank
D02489	Benznidazole	P01CA02	DB11989

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chagas Disease	BR	-	01 Jan 1971

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01549236 (Pubmed)	Phase 4	-	81	Benznidazole 7.5 mg/kg/d	lgkycpizst(mpwiprjqtj) = mild AEs irtetlmnzc (yqtwndydkf )	-	31 May 2023
NCT01377480 (STOP CHAGAS \| P05267, Pubmed \| J Am Coll Cardiol)	Phase 2	Chagas Disease	120	Posaconazole 400 mg b.i.d.	zbdaaodsgh(ermkzxwzto) = Permanent discontinuation was reported in 19 patients (31.7%) receiving either benznidazole monotherapy or combined with posaconazole vnzehuiftv (opzwcdkoqy ) View more	Positive	28 Feb 2017
				Benznidazole 200 mg + placebo b.i.d.
NCT00123916 (BENEFIT, Pubmed \| Br Dent J) Manual	Phase 3	Chagas Cardiomyopathy	2,854	Benznidazole	xuxbhvidwf(supztzptvr) = epuppukxid vccwfcsoun (scjoqccdxj ) View more	Negative	01 Oct 2015
				Placebo	xuxbhvidwf(supztzptvr) = xytivgxsvy vccwfcsoun (scjoqccdxj ) View more
NCT01755403 \| EUCTR2011-002900-34-ES (Pubmed \| Antimicrob Agents Chemother)	Phase 4	Chagas Disease	39	Benznidazole 2.5 mg/kg/12 h	ezpurtqqnq(snlkmkvotm) = hcitqnoibe xfxlmonsaz (xgjdtfinzn ) View more	-	01 Jan 2015
NCT02386358 (Pubmed \| Ann Intern Med)	Phase 3	Chagas Cardiomyopathy	566	Benznidazole	sjoaefvbuh(hfsyhmsaad): hazard ratio = 2.1 (95% CI, 1.06 - 4.06), P-Value = 0.034	-	16 May 2006
				benznidazole (No treatment)
NCT02386358 (Pubmed \| Am Heart J)	Phase 3	Chagas Cardiomyopathy	910	Benznidazole-treated patients	gqcdfeloul(gcjljjxnkw) = xylkhpyuzp kurbyvailr (kybjfxyacg ) View more	-	01 Jan 1994
				benznidazole (Untreated patients)	gqcdfeloul(gcjljjxnkw) = pjrkarnyts kurbyvailr (kybjfxyacg ) View more

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