US/UK/Canada

Share

Pick a time period -
Tags ( Active)

OxThera reports results from Phase 3 ePHex study with Oxabact in primary hyperoxaluria patients with maintained kidney function

Stockholm – 11 June 2021. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces completion of its pivotal Phase 3 study and reports top line results.OxThera’s 52-week OC5-DB-02 study “A Phase III Double-Blind, Randomised Study to Evaluate the Long-Term Efficacy and Safety of Oxabact® in Patients with Primary Hyperoxaluria” (ePHex) enrolled patients with all types of PH, who had to have a plasma oxalate (Pox) concentration ≥ 10 μmol/L and an eGFR < 90 ml/min/1.73 m[2] during screening to be eligible for

New OxThera/Oxabact US patent granted

Stockholm – 25 February 2021. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces that a new US patent has been granted for its product candidate Oxabact announces that a new US patent has been granted for its product candidate Oxabact, and for a method for the treatment or prevention of an oxalate-related disorder, such as hyperoxaluria.The first formulation of Oxabact was patented and granted back in 1999. Since 2012, the company has developed a new, high-concentrated formulation of Oxabact designed

Plasma oxalate and kidney function are correlated in patients with primary hyperoxaluria with maintained kidney function – Data from three placebo‑controlled studies published

Stockholm – 19 February 2021. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces the publication of an article in Pediatric Nephrology, on the significant correlation between plasma oxalate and kidney function in three controlled clinical trials with PH patients.Primary hyperoxaluria is a rare autosomal recessive inherited disorder of glyoxylate metabolism that causes an endogenous overproduction of oxalate. Oxalate cannot be degraded in humans and is mostly eliminated by the kidneys. The oxalate

OxThera Receives Rare Pediatric Disease Designation from U.S. FDA for Oxabact Treatment of Primary Hyperoxaluria

Stockholm – June 26 2020. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Rare Pediatric Disease Designation for Oxabact OC5. The FDA stated, that based on information provided by OxThera, there is sufficient documentation to demonstrate that nephrocalcinosis, nephrolithiasis, growth failure, and oxalate retinopathy are serious manifestations of PH that primarily affect children. Therefore, Oxabact is eligible for and has been

Organizational update - New board member and new CFO

Kirsti Gjellan is new board member of OxThera as of 19 May 2020. “It is my pleasure to welcome Kirsti to the board of OxThera”, said Dr. Georges Gemayel, Chairman of Oxthera. “Her deep biologic manufacturing experience and successful track record of business leadership over her career will be of important value to Oxthera in its development of Oxabact for treating Primary hyperoxaluria.” “I am honored to join OxThera”, says Kirsti Gjellan. “I believe the company is poised to make a real difference in patients suffering from this devastating rare disease. I am excited to share my

OxThera announces completion of recruitment in Phase 3 ePHex study with Oxabact® in patients with primary hyperoxaluria

Stockholm - 6 April 2020. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announced today that it has completed enrollment in its Oxabact ePHex phase III study.Oxabact is an investigational bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes for the treatment of adults and children with primary hyperoxaluria (PH) of all types. The objective of the study is to treat PH and prevent or delay kidney deterioration. OxThera is on track to report top-line results from ePHex

Oxabact[®] treatment combined with intensive dialysis lowers plasma oxalate and halts disease progression in a patient with severe infantile oxalosis

Stockholm – March 12, 2020. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces the publication of a case report in Pediatric Nephrology. The report summarizes data from a 22-month course of treatment with Oxabact in a female infant with Primary Hyperoxaluria type 1 (PH1) and severe infantile oxalosis on dialysis. The treatment reduced plasma oxalate levels and stabilized systemic oxalosis.Infantile oxalosis, the most devastating form of primary hyperoxaluria type 1 (PH1), often leads to end-stage renal

OxThera presents full 24-month data for Oxabact ® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD at Kidney Week 2019

WASHINGTON D.C., US – November 7, 2019. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today presents data from a 24-month interim analysis of an ongoing phase 2 trial evaluating Oxabact® in PH type 1 (PH1) patients with end stage renal disease (ESRD). The results showing a continued reduction in plasma oxalate levels and improved or stable cardiac function, are being presented today during a poster session at ASN Kidney Week 2019 in Washington DC.Study OC5-OL-01 is evaluating Oxabact in PH1 patients with

OxThera receives positive decision from EMA on Paediatric Investigational Plan (PIP) for treatment of primary hyperoxaluria with Oxalobacter formigenes

STOCKHOLM, SWEDEN – August 23, 2019. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that, based on a positive opinion from the Paediatric Committee (PDCO), the EMA has agreed to the proposed PIP for Oxalobacter formigenes in the treatment of primary hyperoxaluria.“We are pleased to announce this important regulatory milestone. The approval of the Paediatric Investigational Plan provides us with a clear development path for Oxabact in the treatment of paediatric patients with primary

OxThera presents continuous strong data from an interim analysis of its Phase 2 study with Oxabact in Primary Hyperoxaluria

STOCKHOLM, SWEDEN – June 27, 2019. OxThera AB, a privately-held biopharmaceutical company dedicated to improve the lives of people living with Primary Hyperoxaluria (PH), today announced continuous strong data from a two-year interim analysis of its Phase 2 study with Oxabact® in PH.OC5-OL-01 is the longest efficacy and safety study of any intervention to lower the oxalate burden in patients with PH. The two-year interim analysis shows continuous reductions in Pox (level of oxalate in the blood plasma) of - 40% (-67 µmol/L) compared with baseline. In addition, a normalization in cardiac

OxThera initiates extension part of a Phase 3 study of Oxabact in Primary Hyperoxaluria

STOCKHOLM, SWEDEN – June 20, 2019. OxThera AB, a biopharmaceutical company dedicated to improve the lives of people living with Primary Hyperoxaluria, today announced that the first patients in a Phase 3 study of Oxabact® have completed the study and transitioned to an open-label extension part. All clinics participating in the study will continue to treat patients in the extension part for another two years. Topline results from the Phase 3 study are expected in the first quarter of 2021.Primary Hyperoxaluria is a rare autosomal recessive disorder leading to markedly elevated levels of

OxThera AB is being granted US patent for Oxalobactersecretagogues

OxThera AB, a privately-held Stockholm-based biopharmaceutical company, today announced a granted US patent on Oxalobacter formigenes secretagogues. Oxabact® , a formulation of highly concentrated lyophilized Oxalobacter formigenes, is being developed by OxThera AB as a potential treatment for patients with primary hyperoxaluria (PH). Oxabact® is designed to increase the intestinal secretion of oxalate from  plasma and thereby decrease and prevent oxalate crystal accumulation and kidney deterioration. Oxalobacter formigenes produces specific secretagogues that enhance active

OxThera presents encouraging 52-week efficacy and safety data for Oxabact® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD

OxThera AB, a Stockholm-based privately-held biopharmaceutical company and leader in the field of microbiome derived biotherapeutics, today announced a poster presentation showing encouraging Oxabact® efficacy and safety data from the longterm study OC5-OL-01, at the Annual Meeting of the American Society of Nephrology Kidney Week 2018 in San Diego. ”We are pleased to present the initial outcomes after a 52-week continuous treatment with Oxabact® in patients with Primary Hyperoxaluria treated with maintenance dialysis”, says Matthew Gantz, CEO of OxThera. ”To our knowledge, study OC5-OL-

Hugo Petit Appointed CFO of OxThera

Stockholm – 7  September 2018 – OxThera AB, a Stockholm-based privately-held rare disease company today announced the appointment of Hugo Petit as its new Chief Financial Officer. Mr Petit previously served as the Chief Financial Officer of MedCap AB. While at MedCap, Hugo led the company’s listing on Nasdaq Stockholm. Prior to joining MedCap, Hugo held several roles as Chief Financial Officer in small as well as medium sized companies. Earlier in his career, Hugo also spent several years as consultant at McKinsey & Company in Stockholm. “It is my pleasure to welcome Hugo as CFO of

OxThera updates on Phase 3 study with Oxabact® in Primary Hyperoxaluria

OxThera AB, a Stockholm-based privately-held biopharmaceutical company, today announced that the Phase 3 study with Oxabact® in Primary Hyperoxaluria (PH) is now fully open for recruitment.  All clinics participating in the study are approved by Competent authorities in Europe and US and are initiating patient screening. ”We are pleased to announce that we are now fully open for enrolment in our Phase 3 study with Oxabact® in Primary Hyperoxaluria”, says Matthew Gantz, CEO of OxThera. ”In fact, we have already enrolled several patients. We are confident that our new Oxabact® product has

OxThera announces the appointment of Dr Alain Munoz to its Board of Directors

Stockholm – 13 June 2018 – OxThera AB, a Stockholm-based privately-held biopharmaceutical company with a product in late stage clinical development focusing on Primary hyperoxaluria (PH), announces the appointment of Dr Alain Munoz to its board of directors. “It is my pleasure to welcome Alain to the board of Oxthera”, said Dr. Georges Gemayel, Chairman of Oxthera. “His deep industry experience and successful track record of clinical development and business leadership over his career will be of important value to Oxthera in its development of Oxabact for treating Primary hyperoxaluria.”

OxThera announces the randomization of the first patient into its phase III EPHEX study with Oxabact

Stockholm – 15 March 2018 – OxThera AB, a Stockholm-based privately-held biopharmaceutical company with a product in late stage clinical development focusing on Primary hyperoxaluria (PH), announces the randomization of the first patient into its phase III study, EPHEX, with Oxabact. Study OC5-DB-02 (EPHEX) is a randomized, placebo-controlled, 52-week study with the goal to investigate the efficacy and safety of Oxabact in patients with PH. The purpose of the study is to show that Oxabact can halt or delay the disease progression and preserve kidney function. “This is an important

OxThera Strengthens Patent Portfolio for treatment of Hyperoxaluria

OxThera AB announced today that it has recently been granted two new US patents, three new European patents and patents in Canada, China, Hong-Kong, India and Japan. OxThera now holds proprietary rights to pharmaceutical preparations and their use for treatment of hyperoxaluria in nine patent families. The newly granted US patents have numbers US8900575 and US8940295 covering pharmaceutical compositions of oxalate decarboxylase. The new European patents have numbers EP2449098 covering pharmaceutical compositions of oxalate decarboxylase, EP1771201 and EP1965816 covering pharmaceutical

OxThera appoints new Chief Medical Officer

Stockholm – 12 October 2017 – OxThera AB, a Stockholm-based privately-held biopharmaceutical company today announced the appointment of Dr Bastian Dehmel as their new Chief Medical Officer. OxThera is developing a novel treatment, Oxabact, for Primary hyperoxaluria (PH), a severe and often fatal disease in children, and where there are currently no available therapies. The company is poised to initiate a pivotal Phase III study in PH with Oxabact in order to stop and/or delay disease progression. “It is my pleasure to welcome Bastian as CMO of OxThera”, said Matthew Gantz, CEO of

Matthew Gantz Appointed CEO of Oxthera

Stockholm – 5 July 2017 – OxThera AB, a Stockholm-based privately-held biopharmaceutical company today announced the appointment of Matthew Gantz as their new CEO. He succeeds Elisabeth Lindner as CEO, who will continue as COO of Oxthera overseeing the Oxabact program. OxThera is developing a novel treatment, Oxabact, for Primary hyperoxaluria (PH), a fatal disease in children, and where there are currently no available therapies. The company is poised to initiate a pivotal Phase III study in PH with Oxabact in order to stop and/or delay disease progression. “It is my pleasure to

OxThera Raises EUR 32 Million to Complete Development of Oxabact® for Treatment of Primary Hyperoxaluria

OxThera AB, a Stockholm-based privately-held biopharmaceutical company, announces today that it has agreed on a EURO 32 million investment to complete the Oxabact®development program for treatment of Primary hyperoxaluria.    The investment round is co-led by Life Sciences Partners, Netherlands, Ysios Capital, Spain, Sunstone Capital, Denmark, and Flerie Invest, Sweden, in addition to current shareholders Kurma Partners, France, Idinvest Partners, France, Stiftelsen Industrifonden, Sweden, and Brohuvudet, Sweden. This announcement bolsters OxThera’s position as a leader in developing

Pivotal study is being conducted with Oxabact™ for the treatment of Primary Hyperoxaluria

OxThera today announced that all 42 patients have been enrolled in their pivotal phase II/III study using Oxabact™ for the treatment of Primary Hyperoxaluria. Results from this multicenter study will be presented during Q4 of 2008 and be used to file for licensure in EU, US and the rest of the world.Primary Hyperoxaluria is a rare genetic disease in which excessive oxalate is produced by the liver and excreted in the urine by the kidneys. High levels of urinary oxalate cause kidney stones and/or calcification of the kidney which could lead to kidney failure and in many cases premature

There are no items matching the current filter
There are no more items matching the current filter
Back to top