albireo pharma odevixibat

ASSERT is a gold standard, prospective intervention trial. About OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. EMA has also granted orphan designation to odevixibat for the treatment of biliary atresia, Alagille syndrome and primary biliary cholangitis. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life, and as many as 88% also present with severe, intractable pruritus. The most prominent and problematic ongoing manifestation of the disease is pruritus, or intense itching, which often results in a severely diminished quality of life. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia. ASSERT is Albireo’s third global trial in rare cholestatic liver conditions and furthers the Company’s efforts to deliver life-changing therapies to children and young adults living with these diseases. In addition, the FDA has granted orphan drug designation to odevixibat for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Children have clay-colored or no color in their stools and jaundice, among other things, and a few patients are pruritic. Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial the BOLD Phase 3 trial in patients with biliary atresia, and the global Phase 3 ASSERT trial for ALGS. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical  trials; and Albireo’s critical accounting policies. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. Albireo recently submitted for a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat for the treatment of patients with PFIC. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. Accordingly, a product capable of inhibiting the IBAT could lead to a reduction in bile acids returning to the liver and may represent a promising approach for treating cholestatic liver diseases. Albireo cautions you not to place undue reliance on any forward-looking statement. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC and biliary atresia. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the initiation of its global Phase 3 pivotal trial, ASSERT, Alagille Syndrome looking at Safety and Efficacy in a Randomized controlled Trial, which will evaluate odevixibat in patients with Alagille syndrome. BOSTON, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions in serum bile acids (sBAs) and improvements in pruritus for odevixibat, a potent, once-daily, non-systemic ileal bile acid … Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed on the study design and have indicated that a single study demonstrating safety and efficacy of odevixibat would be sufficient for regulatory filings. The firm currently has a “buy” rating on the biopharmaceutical company’s stock. About AlbireoAlbireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Equal Opportunity Employer. The EMA has granted odevixibat accelerated assessment, orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. For more information on Albireo, please visit www.albireopharma.com. Progressive Familial Intrahepatic Cholestasis (PFIC), progressive familial intrahepatic cholestasis. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events were mostly mild or moderate. Odevixibat is also currently being evaluated in the BOLD (NCT04336722) Phase 3 clinical trial in patients with biliary atresia. The Company has also initiated the ASSERT double-blind, randomized, placebo-controlled global Phase 3 trial of odevixibat in Alagille syndrome to evaluate the safety and efficacy of odevixibat in relieving pruritus in patients with Alagille syndrome. Albireo Pharma (NASDAQ:ALBO) has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat … About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Lucy Parsons Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. Albireo Pharma (NASDAQ:ALBO) presented positive results from two Phase 3 trials of odevixibat at the American Association for the Study of Liver Diseases meeting.. Odevixibat is an ileal bile acid transport inhibitor being developed for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder that causes progressive, life-threatening liver disease. The Company completed IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. For more information about the PEDFIC 2, ASSERT or BOLD studies, please visit ClinicalTrials.gov or contact medinfo@albireopharma.com. Albireo is committed to the development of new medicines to improve the lives of patients suffering from liver diseases and their families. With U.S. and EU regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. Albireo Pharma Overview: Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. The resulting bile build-up in liver cells causes liver disease and symptoms. But, for these patients, there may be a bright light at the end of the tunnel in the form of Albireo Pharma’s ileal bile acid transport inhibitor (IBATi) odevixibat. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. On December 8, 2020, Albireo Pharma, Inc. issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the  pivotal trial for odevixibat in Alagille syndrome (ASSERT); the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. During the trial, odevixibat "reduced serum bile acid … Albireo Pharma (NASDAQ:ALBO) had its price objective hoisted by analysts at HC Wainwright from $67.00 to $75.00 in a research report issued on Friday, AR Network reports. About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Albireo is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. The Boston Business Journal named Albireo … Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. The Boston Business Journal named Albireo … Albireo Pharmaceuticals Boston, USA-based biotech Albireo Pharma has submitted a New Drug Application (NDA) to the US Food and… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. The trial is expected to enroll approximately 45 patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS across 35 sites in North America, Europe, Middle East and Asia Pacific. Albireo Pharma (NASDAQ: ALBO) announces new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions … The double-blind, randomized, placebo-controlled trial is designed to evaluate the safety and efficacy of 120 µg/kg/day odevixibat for 24 weeks in relieving pruritus in patients with ALGS. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). With normal function, approximately 95 percent of bile acids released from the liver into the bile ducts to aid in liver function are recirculated to the liver via the IBAT in a process called enterohepatic circulation. We do not sell or distribute actual drugs. About Alagille SyndromeAlagille syndrome (ALGS) is a rare, multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys and facial features. BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile … Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being investigated for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome (ALGS). Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Odevixibat - Albireo AB Alternative Names: A-4250 Latest Information Update: 10 Nov 2020. Media Contact:Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com, Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177, Contact |  Terms of Use  |  Privacy Policy, Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis (PFIC). ALGS is a rare multisystem genetic disorder that can affect the liver, heart and other parts of the body. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. The Boston Business Journal named Albireo … Secondary endpoints will measure serum bile acid levels and safety and tolerability. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the initiation of its global Phase 3 pivotal trial, ASSERT, Alagille Syndrome looking at Safety and Efficacy in a Randomized controlled Trial, which will evaluate odevixibat in patients with Alagille syndrome. Albireo's odevixibat is a potent and selective IBAT inhibitor We are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases -, - ASSERT gold standard study design in Alagille syndrome -, - Product submission of once-daily odevixibat for patients with PFIC under review by FDA and EMA -. Odevixibat is being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) designed to assess long-term safety and durability of response in a cohort of patients rolled over from PEDFIC 1 and a second cohort of PFIC patients who are not eligible for PEDFIC 1. In people with cholestatic liver diseases, the bile flow is interrupted, resulting in elevated levels of toxic bile acids accumulating in the liver and serum. Additionally, interim results from PEDFIC 2, an open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments, and encouraging markers of liver and growth function in patients treated up to 48 weeks. Other symptoms include jaundice, poor weight gain and slowed growth. The Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with PFIC and anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and even liver failure. Odevixibat does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and … About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Currently, there is no approved drug therapy for the treatment of ALGS. HC Wainwright’s price target indicates a potential upside of 83.91% from the company’s previous close. Price : $50 * Buy Profile. There are several forms of PFIC, but Albireo Pharma's phase 3 study focused on PFIC1 and PFIC2. The odevixibat PFIC program, or elements of it, have received fast track, rare pediatric disease and orphan drug designations in the United States. “We are pleased to initiate the ASSERT study within guidance and offer hope to children and young adults around the globe with Alagille syndrome who have no approved therapeutic options today.”. BOSTON, Jan. 29, 2020(GLOBE NEWSWIRE) -- Albireo Pharma, Inc.(Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced a number of advances and new initiatives in the clinical program for odevixibat, an oral once-daily capsule in development for the treatment of progressive familial intrahepatic cholestasis (PFIC), biliary atresia … With limited treatment options beyond invasive medical procedures, cholestatic liver diseases are devastating for adults and children. Adis is an information provider. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. The Company provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug treatments. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Currently, there are no approved drug treatments. Final gross price and currency may vary according to local VAT and billing address. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. Approximately 95% of patients with ALGS present with chronic cholestasis, usually within the first three months of life, and up to 88% also present with severe, intractable pruritus. Contact |  Terms of Use  |  Privacy Policy. The randomized, double-blind, placebo-controlled, global multicenter PEDFIC 1 Phase 3 clinical trial of odevixibat in 62 patients, ages 6 months to 15.9 years, with PFIC type 1 or type 2 met its two primary endpoints demonstrating that odevixibat reduced serum bile acids (sBAs) (p=0.003) and improved pruritus (p=0.004). JOIN ALBIREO. Albireo Pharma (ALBO) Begins Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome . BOLD, the largest prospective intervention trial ever conducted in biliary atresia, is a double-blind, randomized, placebo-controlled trial which will enroll approximately 200 patients at up to 75 sites globally to evaluate the efficacy and safety of odevixibat in children with biliary atresia who have undergone a Kasai procedure before age three months. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Additional information on PFIC is available at https://www.pficvoices.com. “Odevixibat is the first IBAT inhibitor to have demonstrated efficacy and tolerability in a Phase 3 randomized, placebo-controlled trial, and this gives us increased confidence for positive clinical outcomes in Alagille syndrome with ASSERT,”  said Ron Cooper, President and Chief Executive Officer of Albireo. Well tolerated, and treatment-emergent adverse events were mostly mild or moderate external biliary diversion ( PEBD ) liver. Invasive medical procedures, cholestatic liver diseases are devastating for adults and children information on PFIC is at... Time of purchase is available at https: //www.pficvoices.com is also currently being evaluated in the U.S. Canada... Faces, the results or events indicated by any forward-looking statement may not.! 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