Breaking News
April 24, 2018 - Study sheds new light on how bilinguals process language
April 24, 2018 - Probiotics can improve liver health, shows study
April 24, 2018 - Study may explain how chemoresistance evolves over time in some triple-negative breast cancers
April 24, 2018 - Role of midbrain in encoding identity errors
April 23, 2018 - Salamander study provides clues for treating spinal cord injuries
April 23, 2018 - Relaxation after work could give better night’s sleep
April 23, 2018 - Loneliness on its way to becoming Britain’s most lethal condition
April 23, 2018 - Low-cost blood test for multiple myeloma can deliver same diagnostic information as bone biopsy
April 23, 2018 - Metabolic differences may contribute to postpartum weight retention in black moms
April 23, 2018 - Time-Related Deployment Factors Predict Suicide Attempt Risk
April 23, 2018 - Are newborns ugly? Research says newborns rated ‘less cute’ than older babies
April 23, 2018 - Prenatal marijuana use linked to increased chance of low birth weights
April 23, 2018 - Researchers identify target gene in P. aeruginosa infection
April 23, 2018 - New studies related to causes of liver degradation and possible treatments
April 23, 2018 - Studies offer leads for new approaches to treat neurological problems
April 23, 2018 - Gene Therapy May Be Cure for Some With Rare Blood Disorder
April 23, 2018 - Obesity impacts liver health in kids as young as eight years old
April 23, 2018 - Frequent cannabis use by young people linked to small reductions in cognitive function
April 23, 2018 - Innovative research could lead to new ways to treat, prevent cancer
April 23, 2018 - Study uncovers possible source of gender differences in migraines
April 23, 2018 - Study proves usefulness of EDX testing in diagnosis, management of neuromuscular disorders
April 23, 2018 - Hacking ‘drug trafficking’ system could increase effectiveness of diabetes treatment
April 23, 2018 - Clinical trial to examine stem cell therapy for treatment, prevention of complications after traumatic injury
April 23, 2018 - Targeted radiotherapy found to be a good option for women with early breast cancer
April 23, 2018 - Eating fish could prevent Parkinson’s disease
April 23, 2018 - Philips showcases dedicated radiation oncology solutions at ESTRO 2018
April 23, 2018 - Key factor in development of Parkinson’s disease identified
April 23, 2018 - Higher consumption of fish linked to better neurological health
April 23, 2018 - Genevac announces HT Series 3 evaporators with Inert Gas Purge option
April 23, 2018 - Researchers clarify immune response for patients with breast cancer brain metastases
April 23, 2018 - Polypharmacy More Likely for Cancer Survivors
April 23, 2018 - Obesity is shifting cancer to young adults
April 23, 2018 - Scientists illustrate role of novel chromosomal mutations in fosfomycin resistance
April 23, 2018 - Newly developed drug compound may help treat Charcot-Marie-Tooth disease
April 23, 2018 - Marriage Means ‘I Do’ for Skin Cancer Detection
April 23, 2018 - Freezing hunger-signaling nerve may help ignite weight loss
April 23, 2018 - Wear exoskeletons with caution for heavy lifting, researchers say
April 23, 2018 - Research offers new hope for healing wounds in patients with diabetes
April 23, 2018 - Shorter courses of radiotherapy found to be safe, effective for prostate cancer patients
April 23, 2018 - Scientists use CRISPR tool to make multiple edits to DNA samples ‘in vitro’
April 23, 2018 - Knee reconstructions are on the rise among the youth in Australia
April 23, 2018 - Artificial sweeteners linked to obesity warn researchers
April 23, 2018 - CDC seeking $400 million to replace lab for deadliest germs
April 23, 2018 - Sensirion to present single-use liquid flow sensor at COMPAMED 2017
April 23, 2018 - FDA approves contact lenses that shade the sun
April 22, 2018 - Concussion recovery and symptom severity found to vary between men and women
April 22, 2018 - C. Difficile Risk Higher With Stoma Reversal Versus Colectomy
April 22, 2018 - Repeated ranibizumab doesn’t impair macular perfusion
April 22, 2018 - New microscope reveals how cells behave in 3D and real time inside living organisms
April 22, 2018 - Study shows clinical benefit and monetary gains of weight-loss surgery
April 22, 2018 - GNA Biosolutions launches world’s first Laser PCR platform at Medica Trade Fair
April 22, 2018 - Researchers present simulation model to investigate hospital responsiveness to mass casualty incidents
April 22, 2018 - Does Pot Really Dull a Teen’s Brain?
April 22, 2018 - Controversial pregnancy test drug shows deformities in zebrafish embryos within hours of exposure
April 22, 2018 - New research partnership makes childbirth safer in Mozambique
April 22, 2018 - Brief bedside visual art intervention reduces pain, anxiety in cancer patients
April 22, 2018 - The memory part of the brain may also hold clues for anxiety and depression
April 22, 2018 - AYOXXA to develop multiplex immunoassay to support treatment of sepsis patients
April 22, 2018 - New Drug Combo Ups Survival in HER2/neu Uterine Serous Cancer
April 22, 2018 - Researchers chart a new way to look at concussion
April 22, 2018 - Every parent needs to know fundamental red flags for autism
April 22, 2018 - Anatotemp expands anatomic dental implant healing abutments with 4Side anti-rotational connection
April 22, 2018 - Gene Twist Can Make Your Blood Pressure Spike From Salt
April 22, 2018 - Study suggests failed osteoarthritis drug could help treat opioid addiction
April 22, 2018 - More Americans aware of growing problem of opioid addiction
April 22, 2018 - KHN’s ‘What the Health?’ Nothing in health care ever goes away
April 22, 2018 - BGS to promote high-quality sterilization services at Health GB in Manchester
April 22, 2018 - New integrated POC tool detects biomarkers of heart failure rapidly and precisely
April 22, 2018 - Direct electrical current can be delivered to nerves for blocking pain signals
April 22, 2018 - Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality
April 22, 2018 - Healthy red blood cells owe their shape to muscle-like structures
April 22, 2018 - Researchers present case study of management of rheumatic mitral regurgitation in woman contemplating pregnancy
April 22, 2018 - New black Porvair Krystal UV Quartz microplates for Circular Dichroism measurements
April 22, 2018 - Advanced flow chemistry modules enhance control of nanoprecipitation
April 22, 2018 - Look! Down in the petri dish! It’s a superplatelet!
April 22, 2018 - Research reveals why people with tetraplegia more likely to suffer from sleep apnea
April 21, 2018 - New non-invasive nerve stimulation may offer relief for people with hand tremor
April 21, 2018 - Smartphone App May Up Medication Adherence in HTN
April 21, 2018 - Western diet depletes artery-protecting immune cells
April 21, 2018 - Excelitas Technologies launches new powerful LED light source for fluorescence microscopy
Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy

Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy

image_pdfDownload PDFimage_print

SOUTH SAN FRANCISCO, Calif., April 3, 2018 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys. The trial did not achieve statistical significance for its primary endpoint, which was mean change in proteinuria comparing fostamatinib dose groups to placebo controls in all patients studied. However, in a pre-specified subgroup analysis of patients with greater than 1 gram/day of proteinuria at baseline, the initial data showed a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo patients (this finding did not reach statistical significance). Patients with greater than 1 gram/day of proteinuria have an increased risk of disease progression and represent an unmet medical need. Current guidance for clinical trials in IgAN recommends studying patients with greater than 1 gram/day of proteinuria at entry. Further analysis, including histology, are expected later in the year.

“We find the subgroup analysis encouraging because patients and physicians have been challenged to manage this serious disease that has no approved treatment options,” stated Raul Rodriguez, president and CEO of Rigel. “This study has provided valuable information on the potential benefit of fostamatinib in IgA nephropathy patients with significant need, those with greater than 1 gram/day of proteinuria. We will continue to evaluate the data to determine the best path forward in this indication.”

Fostamatinib in IgAN

The Phase 2 study of fostamatinib in IgAN enrolled patients in multiple centers throughout the U.S., Asia and Europe. For inclusion, patients were required to have a diagnosis of IgAN verified by biopsy and proteinuria greater than 500 mg/day. Patients (n=76) were randomized into one of three groups: placebo, fostamatinib at 100 mg bid or fostamatinib at 150 mg bid for 24 weeks. The study evaluated the safety and efficacy as measured by change in proteinuria and renal function. The mean change in proteinuria (sPCR) was -177, -577, and -158 mg/g for the placebo, 100 mg bid and 150 mg bid dose groups, respectively. This result was not statistically significant.

Fostamatinib was well tolerated with mostly mild to moderate adverse events, and there were no new safety signals compared to the fostamatinib’s safety database across all indications. The most frequent adverse events were diarrhea, nausea, headache, hypertension and vomiting. Two patients in the 100 mg bid dose group and four in the 150 mg bid dose group discontinued the study due to adverse events. There were six patients with serious adverse events (SAEs), two in each of the placebo, 100mg and 150mg dose groups. Of those six patients, one patient in each fostamatinib group had a drug related SAE. One patient had a fatal SAE, which was not drug related.

“There are no specific therapies or treatment algorithms for the thousands of patients that suffer from this disease. So, it is important to identify a possible treatment for IgA nephropathy to reduce the risk for serious complications of progressing kidney disease, which can culminate in the need for dialysis and kidney transplantation in the worst cases,” stated Professor Frederick Tam, MBBChir PhD FRCP, the Ken and Mary Minton Chair of Renal Medicine, Department of Medicine at Imperial College London, U.K. “This is a very encouraging long term collaboration between Rigel pharmaceuticals and Imperial College London, resulting in translation from laboratory research to treating patients. In this Phase 2 study, the data showed a non-statistically significant trend for fostamatinib to reduce proteinuria within six months in patients with more advanced disease, which is important because there is a higher risk of kidney function loss when proteinuria increases and persists at high levels.”

Rigel plans to seek a pharmaceutical partner to collaborate in the conduct of follow-on clinical studies in IgAN. This partner would take responsibility for the subsequent commercialization of fostamatinib if in an ex-US territory.

About IgAN

IgA nephropathy (IgAN) (also known as Berger’s disease) is a chronic autoimmune disease associated with inflammation in the kidneys that diminishes their ability to filter blood. It is the most common primary glomerular disease, affecting an estimated 82,500 – 165,000 patients in the US, with a higher prevalence in Asia. For as many as 25 percent of those living with IgAN, the disease results in end-stage renal failure requiring dialysis or kidney transplantation. There are no disease-targeted therapies approved for IgAN. Proteinuria is a sign and predictor of the severity of IgA nephropathy. Pre-clinical data show that fostamatinib decreases spleen tyrosine kinase (SYK) activation in the kidney, reverses the inflammation in the glomeruli and improves kidney function.

About Rigel

Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current programs include clinical studies of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has an NDA under review with the FDA for fostamatinib in patients with chronic immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics.

Forward Looking Statements

This release contains forward-looking statements relating to, among other things, the timing of initiation, enrollment and results of clinical trials; Rigel’s belief that fostamatinib may be an important alternative for patients with IgAN; Rigel’s evaluation of ex-US partnerships for fostamatinib and other partnering opportunities across its pipeline; and the timing and results of Rigel’s clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “planned,” “will,” “may,” “should,” “expect,” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the timing, completion and results of clinical trials; market competition; as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the period ended December 31, 2017. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

SOURCE Rigel Pharmaceuticals, Inc.

Posted: April 2018

About author

Related Articles