Artugen Therapeutics Announces First Patient Dosed with ART24, Artugen`s first clinical product candidate for prevention of recurrence of Clostridium difficile infection
- ART24 granted Fast Track Designation
- First Patient Dosed
Concord, Mass., and Dublin, Ireland March 12, 2020 — Artugen Therapeutics Limited, a Company developing novel live biotherapeutics (LBPs) for patients living with infectious, inflammatory and oncologic diseases announced today the first patient dosed with ART24, the Company’s first clinical product candidate for prevention of recurrence of Clostridium difficile infection (CDI).
The advancement of ART24 into the Phase 1 clinical trial was based on its favorable profile exhibited in pre-clinical safety testing, as well as its demonstration of potent and selective in vitro and in vivo activity against C. difficile and associated toxins. The Phase 1 clinical trial is evaluating ART24 for safety, tolerability and pharmacokinetics in a double-blind, placebo-controlled study in patients recently cured of CDI.
ART24 was additionally granted Fast Track by the FDA.
“We are thrilled by the remarkable progress made by the Artugen team and excited about the advancement of the clinical development of ART24,” said CEO Ronnie Farquhar. “Thousands of people die each year due to recurrent C. difficile infections and we are pleased that the FDA has granted the ART24 program Fast Track Status.”
C. difficile has been categorized as an urgent threat by the Centers for Disease Control and is estimated to cause almost half a million illnesses in the United States each year. Even when successfully treated, CDI recurrence is common and can be as high as 60% in patients who have experienced multiple episodes. Given that an estimated 15,000 deaths are directly attributable to C. difficile infections, preventing CDI recurrence is a critical therapeutic strategy in the management of CDI.
“I am excited about this novel non antibiotic approach that addresses the prevention of CDI recurrence following a primary episode”, said Dr. Jessica Allegretti, Principal Investigator in the ongoing Phase 1 clinical trial at the Brigham and Women’s hospital in Boston.
“Preventing CDI remains an unmet medical need as each CDI episode has the potential to cause considerable morbidity and mortality,” said Chief Medical Officer, Chris Stevens, MD. “As a first-in-class LBP that acts directly against C. difficile and its toxins, ART24 is a welcome non antibiotic preventative approach to CDI recurrence.”
Top-line results from the Phase 1 trial of ART24 are expected by the end of 2020.
About ART24
ART24 represents a novel class of direct-acting live biotherapeutics (LBPs), which are therapeutic agents with defined clinical benefit claims. As the characterization of the human microbiome and its link to human health has become better understood, the use of LBPs in clinical application represents great opportunity. ART24 is a naturally occurring, pure bacterial strain which was discovered by Artugen Therapeutics in collaboration with APC Microbiome Ireland.
About Artugen Therapeutics
Artugen Therapeutics is a spin-out company from APC Microbiome Ireland and was co-founded in 2016 by Morningside Ventures with Professors Paul Ross and Colin Hill. Artugen is funded by Morningside Ventures and recently closed a $15.2 Million financing to advance the ongoing clinical study in addition to supporting further pipeline build. The discovery arm of Artugen Therapeutics is located in Cork, Ireland and the company has maintained a strong collaborative research partnership with APC Microbiome Ireland.
Related products
Related news
-
Phase III trial with Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer
ARASENS trial demonstrates an increase in overall survival evaluating darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) compared to docetaxel and ADT, a standard of care in metastatic hormone-sensitive prostate cancer (mHSPC) / Bayer plans to present these pivotal data at a forthcoming scientific congress and to discuss them with health authorities / ARASENS is part of broad development program for darolutamide which includes another ongoing Phase III trial in mHSPC, ARANOTE,...
-
SeqOne expands its commercial presence in Middle Eastern markets
SeqOne Genomics, a leader in the field of next generation genomics analysis, announces today a distribution partnership with Global Diagnostic Solutions Ltd (GDS) to commercialize SeqOne’s revolutionary genomics analysis software platform in Middle Eastern markets. Under the terms of this agreement, Global Diagnostic Solutions Ltd. will be responsible for the Business Development, Technical & Logistics Support of SeqOne’s genomic analysis platform in the Middle-East North Africa (MENA) Region:...
-
Trailblazing leader named Melburnian of the Year
Since moving to Melbourne from West Virginia over 30 years ago, O`Neal has forged a successful career as a lawyer, and in 2013 became the first-ever female president of an AFL club. O`Neal is also a board member of Women’s Housing Ltd – helping disadvantaged and vulnerable women gain access to safe housing. Previous Melburnian of the Year winners include leading medical researcher, Professor Doug Hilton AO and radiation oncologist and tobacco-free lobbyist, Dr Bronwyn King AO. The prestigious...
-
Creative Proteomics Launches Oncology Multi-omics Platform to Promote Basic Oncology Research
Using its mature multi-omics technology platform, Creative Proteomics has been devoted to providing high-quality, personalized oncology multi-omics services and reliable data support to worldwide clients for years. With the continuous aging of human society, the improvement of industrialization, and the deterioration of the quality of living environment, the incidence of cancer is getting higher and higher. Elucidating the mechanisms of tumorigenesis is utterly dire and a crucial research topic. The use of...
-
Melbourne Awards celebrate city’s best and brightest
Lord Mayor Sally Capp said 2021’s finalists have gone above and beyond to make our city better. “We’re thrilled to recognise and celebrate the inspirational people who are making invaluable contributions to our city,” the Lord Mayor said. “It’s the people that make our city the wonderful place it is, and the Melbourne Awards finalists are a testament to our passionate and innovative community.” This year’s Melbourne Awards feature two new categories –...
Customer comments
No comments were found for Artugen Therapeutics Announces First Patient Dosed with ART24, Artugen`s first clinical product candidate for prevention of recurrence of Clostridium difficile infection. Be the first to comment!