whytestocks
6年前
Just In: $ALBO Albireo Announces Proposed Public Offering of 3,000,000 Shares of Common Stock
BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that it has commenced a proposed underwritten public offering of 3,000,000 shares of its common stoc...
In case you are interested ALBO - Albireo Announces Proposed Public Offering of 3,000,000 Shares of Common Stock
crudeoil24
6年前
ALBO > 14M trading float > up 70%. FDA phase III news:
Albireo Announces Phase 3 Trial Of Odevixibat Met Both Primary Endpoints
6:37 am ET September 8, 2020 (Benzinga) Print
-Highly statistically significant reductions in both pruritus and serum bile acids-
-Well tolerated with very low incidence of diarrhea-
-Similar efficacy in children with PFIC1 or PFIC2-
-Pivotal trial results substantiate potential for odevixibat to be first drug for PFIC patients-
-Regulatory submissions for approval on track-
-Conference call to be held today at 8:30 a.m. EDT-
BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced positive topline results from PEDFIC 1, a global Phase 3 clinical trial evaluating the efficacy and safety of odevixibat and the largest study ever conducted in PFIC1 and PFIC2. PEDFIC 1 met its two primary endpoints, demonstrating that odevixibat reduced serum bile acid responses (sBAs) (p=0.003) and improved pruritus assessments (p=0.004) with a single digit diarrhea rate. Odevixibat is a highly potent, non-systemic ileal bile acid transport inhibitor (IBATi), for the treatment of progressive familial intrahepatic cholestasis (PFIC) patients.
In the primary analysis, the study met the U.S. regulatory primary endpoint with the proportion of positive pruritus assessments being 53.5% in the odevixibat arms compared to 28.7% in the placebo arm (p=0.004). As a secondary endpoint, 42.9% of patients in the odevixibat arms had a clinically meaningful improvement in the pruritus score, defined as a drop from baseline of 1.0 point or more on the 0-4 point scale, at week 24 compared to 10.5% in the placebo arm (p=0.018). The study also met the EU regulatory primary endpoint with 33.3% of subjects in the odevixibat arms experiencing either a 70% reduction in sBAs or reaching a level of 70 µmol/L compared to no patients in the placebo arm (p=0.003). As a secondary endpoint, mean reduction of bile acids was 114.3 µmol/L in the odevixibat arms compared to an increase of 13.1 µmol/L in the placebo arm (p=0.002). Both doses of odevixibat were statistically significant for each of the endpoints. Odevixibat was well tolerated, with an overall adverse event incidence similar to placebo. There were no drug-related serious adverse events (SAEs) reported during the study. Diarrhea/frequent bowel movements were the most common treatment-related gastrointestinal adverse events which occurred in 9.5% of odevixibat treated patients vs. 5.0% of placebo patients. Full results from the Phase 3 clinical trial will be presented at a future scientific meeting.
"The successful clinical application of IBAT inhibition is all about the ability to lower bile acids and reduce diarrhea rates. Odevixibat reduced bile acids in both PFIC1 and PFIC2 patients and demonstrated a clinically meaningful outcome in pruritus. This is exciting news for children suffering from PFIC who, if odevixibat is approved, may soon have an easy to take, once-daily drug for their life-threatening liver disease," said Ron Cooper, President and Chief Executive Officer of Albireo. "These strong results from PEDFIC 1 increase our confidence in the ongoing BOLD pivotal trial in biliary atresia and the Alagille syndrome study planned for later this year."
"The results of the PEDFIC 1 Phase 3 trial represent the potential for a paradigm shift in the treatment of PFIC," said Richard Thompson, MD, Professor of Molecular Hepatology at King's College London and principal investigator of the study. "These data demonstrate that odevixibat reduced serum bile acids and improved pruritus in patients with PFIC. Coupled with the favourable safety and tolerability profile odevixibat exhibited, these data underscore the potential to improve upon the current standard of care, which typically consists of off-label medications or invasive surgeries including transplant."
"PFIC is a devastating and progressive disease that impacts every facet of a person's life. These positive results represent an important milestone for the PFIC community, many of whose only option is a liver transplant or other invasive surgeries," saidEmily Ventura, President & Co-Founder of the PFIC Network."We appreciate Albireo's vital work in this area, and believe these positive data could bring us one step closer to a safe, effective drug therapy to make a real difference for patients with PFIC and their families."
djpope
10年前
ALBO up 12%+ on EMA (PRIME) acceptance
First News from newly merged Company getting some well deserved attention.
Best to All dp
http://ir.albireopharma.com/releasedetail.cfm?ReleaseID=999534
Albireo’s Lead Product Candidate for Orphan Pediatric Liver Disease Accepted Into European Medicines Agency’s PRIME Program
Program designed to speed up evaluation of investigational medicines for diseases with unmet medical need
BOSTON, Nov. 15, 2016 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that its lead product candidate, A4250, has been granted access to the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of progressive familial intrahepatic cholestasis (PFIC).
“PFIC is a highly debilitating genetic liver disorder that is life altering for affected children and their families,” said Ron Cooper, President and Chief Executive Officer of Albireo. “There is an urgent need for an effective pharmacological treatment for PFIC, as there are currently no approved drug options in the United States or Europe. A4250’s acceptance into the PRIME program serves as validation of its promise to meet that need. We look forward to collaborating with the EMA on the development plan for A4250, as well as the potential accelerated assessment of A4250 in Europe.”
The PRIME program was launched by the EMA to provide enhanced support to developers of investigational medicines that target an unmet medical need, with a focus on those that may offer a major therapeutic advantage over existing treatments or address a disease with no current treatment option. The program is designed to provide early engagement with the EMA to optimize development plans and speed up evaluation, with the goal of helping patients benefit as early as possible from therapies that may significantly improve their quality of life. As of August 2016, only 13 out of 57 requests for PRIME eligibility had been accepted into the program. Having been accepted into the program, A4250 may be eligible for accelerated assessment of a potential future marketing authorization application (MAA) in Europe.
A4250 is currently being evaluated in children with chronic cholestasis in a Phase 2 clinical trial that is intended to support a potentially pivotal clinical trial in PFIC planned to be conducted in the United States and Europe. Albireo anticipates meeting with the U.S. Food and Drug Administration (FDA) regarding the planned PFIC trial in the first quarter of 2017.
About A4250
A4250 is a first-in-class product candidate in development for progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut. A4250 is currently being evaluated in children with chronic cholestasis in a Phase 2 clinical trial that is intended to support a potentially pivotal clinical trial in PFIC.
About Progressive Familial Intrahepatic Cholestasis
Progressive familial intrahepatic cholestasis (PFIC) is a rare genetic disorder that causes progressive, life-threatening liver disease, which may start early after birth or at a young age and rapidly progress to end-stage liver disease. Three alternative gene defects have been identified that correlate to three separate PFIC subtypes, known as types 1, 2 and 3. The precise prevalence of PFIC is unknown, but PFIC has been estimated to affect between one in every 50,000 to 100,000 children born worldwide.
PFIC is commonly associated with elevated serum bile acids. Prominent symptoms of PFIC include pruritus, which is associated with severe sleep disturbance and diminished overall quality of life, and poor growth. First-line treatment in PFIC is typically off-label ursodeoxycholic acid (UDCA). Notwithstanding treatment with UDCA, many PFIC patients will require partial external biliary diversion (PEBD) surgery and ultimately liver transplantation. Although success rates vary, published third-party studies have shown that PEBD surgery can slow, and in some cases stop, the progression of liver disease and lead to reduced pruritus and improved sleep.
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’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
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