Aligos Therapeutics

Robust Pipeline of 55+ Therapies Advancing Toward Potential Functional Cure for Chronic Hepatitis B

a month ago

• Over 50 pharmaceutical companies are actively developing 55+ pipeline therapies for chronic hepatitis B virus (HBV) infection, signaling a robust research landscape aimed at achieving functional cures beyond current suppressive treatments. • Promising candidates include Pradefovir (Ligand Pharmaceuticals) in Phase III and RG6346 (Dicerna/Roche) in Phase II, with the latter demonstrating over 99.9% reduction in circulating HBsAg in preclinical models. • GlaxoSmithKline and Vir Biotechnology are pioneering combination approaches, with GSK evaluating sequential therapy of ASO compound (GSK3228836) and CHB-TI (GSK3528869A) to potentially enhance efficacy over monotherapy in chronic HBV patients.

FDA Accepts Teva's Application for AJOVY in Pediatric Migraine Prevention, Potentially First CGRP Antagonist for Children

a month ago

• The FDA has accepted Teva Pharmaceuticals' supplemental Biologics License Application for AJOVY (fremanezumab) to expand its indication to include prevention of episodic migraine in children and adolescents aged 6-17 years weighing at least 45 kg. • The application is supported by positive Phase 3 SPACE trial results, which demonstrated statistically significant reductions in monthly migraine days and monthly headache days compared to placebo, with a safety profile consistent with adult populations. • If approved, AJOVY would become the first calcitonin gene-related peptide (CGRP) antagonist indicated for migraine prevention in both adults and pediatric patients, addressing a significant unmet need in pediatric migraine care.

Aligos Therapeutics Reports Promising 96-Week Data for HBV Treatment and Positive Results in MASH Study at APASL 2025

2 months ago

• Aligos Therapeutics presented 96-week data showing ALG-000184 achieved significant HBV DNA suppression in both HBeAg-positive and HBeAg-negative patients, positioning it as a potential first-line therapy for chronic hepatitis B. • The Phase 2a HERALD study of ALG-055009 demonstrated robust liver fat reduction in MASH patients, with notable efficacy even in subjects already on GLP-1 agonist therapy, suggesting potential combination treatment approaches. • Both investigational compounds maintained favorable safety profiles while showing best-in-class potential in their respective therapeutic areas, addressing significant unmet needs in liver disease treatment.

New Report Reveals Critical Insights into Clinical-Stage Pharma Partnerships from 2020-2025

2 months ago

• A comprehensive new industry report analyzes over 1,670 clinical-stage partnering agreements in pharma and biotech from 2020-2025, providing unprecedented access to deal structures and financial terms. • The report reveals detailed intelligence on how licensing agreements typically grant exclusive rights across Phase I-III trials, with multi-component structures involving collaborative R&D and commercialization strategies. • Business development professionals can now access actual contract documents and payment triggers often missing from press releases, enabling more effective negotiation strategies and competitive deal structuring.

Aligos Therapeutics Secures $105M Financing to Advance Hepatitis B Drug Development

3 months ago

• Aligos Therapeutics has secured a $105 million private placement financing led by a life sciences investment firm, strengthening its position to advance ALG-000184 into Phase 2 clinical trials for chronic hepatitis B. • The financing structure includes a combination of common stock shares and warrants, with the transaction expected to close by February 13, 2025. • The funding is projected to extend Aligos' cash runway into the second half of 2026, supporting the company's continued development of liver and viral disease therapeutics.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

NASH Treatment Market to Reach Significant Growth by 2032, Driven by Emerging Therapies

6 months ago

• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. • This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes. • Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape. • The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.

Bylvay Demonstrates Sustained Improvement in Itch and Bile Acid Levels in PFIC and ALGS Patients

6 months ago

• Long-term data from Phase III open-label extension studies show Bylvay (odevixibat) provides sustained efficacy in treating Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille syndrome (ALGS). • Patients treated with Bylvay for at least 72 weeks experienced improvements in height, weight, and sleep, alongside sustained reductions in pruritus and serum bile acid levels. • In the PEDFIC 2 study, a clinically meaningful reduction in pruritus score was observed in 42% of PFIC patients under 18 and 61% across various PFIC subtypes. • The ASSERT-EXT study in ALGS patients showed 93% of those continuously on Bylvay experienced a clinically significant reduction in pruritus, with consistent safety profiles observed.

Odevixibat Demonstrates Sustained Improvement in Pruritus and Bile Acid Levels in PFIC and ALGS Patients

6 months ago

• Odevixibat (Bylvay) shows sustained efficacy in reducing pruritus and serum bile acid levels in patients with Progressive Familial Intrahepatic Cholestasis (PFIC) over 72 weeks. • In Alagille syndrome (ALGS) patients, odevixibat treatment led to sustained improvements in pruritus, serum bile acid levels, height, weight, and sleep parameters over 72 weeks. • The safety profile of odevixibat remains consistent, with most adverse events being mild to moderate, primarily gastrointestinal issues like diarrhea. • These findings support odevixibat as a valuable therapeutic option for managing cholestatic pruritus and improving overall outcomes in rare cholestatic liver diseases.

Bylvay Shows Sustained Improvement in Itch and Bile Acid Levels in Rare Cholestatic Liver Diseases

6 months ago

• Data from Phase III open-label extension studies (PEDFIC 2 and ASSERT-EXT) demonstrate Bylvay's sustained efficacy in treating Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille syndrome (ALGS). • Patients treated with Bylvay experienced significant and lasting reductions in pruritus (severe itch) and serum bile acid levels over 72 weeks. • Improvements in height, weight, and sleep patterns were observed in patients with PFIC and ALGS treated with Bylvay, indicating broader benefits beyond symptom management. • The safety profile of Bylvay remains consistent, with most adverse events reported as mild or moderate, supporting its long-term tolerability in pediatric patients.

Aligos Therapeutics' ALG-000184 Receives FDA IND Clearance for Hepatitis B

7 months ago

• Aligos Therapeutics received FDA clearance for its Investigational New Drug (IND) application for ALG-000184, a capsid assembly modulator for chronic hepatitis B (CHB). • A Phase 1 Drug-Drug Interaction (DDI) study will assess the impact of cytochrome P450 inhibitors and inducers on ALG-000184 pharmacokinetics. • Phase 2 enabling activities are underway, with a Phase 2 study filing anticipated in Q1 2025, evaluating ALG-000184 against standard of care in CHB subjects. • ALG-000184 has demonstrated broad antiviral activity, potentially improving outcomes compared to current treatments for chronic hepatitis B.

Aligos Therapeutics' ALG-055009 Shows Promise in Phase IIa MASH Trial

8 months ago

• Aligos Therapeutics announced positive results from its Phase IIa HERALD trial of ALG-055009 for MASH, demonstrating notable liver fat reduction. • The trial, involving 102 subjects, showed that doses of ALG-055009 led to up to 70% of subjects experiencing a ≥30% relative decrease in liver fat. • ALG-055009 exhibited a favorable tolerability profile with mainly mild to moderate adverse events and significant decreases in atherogenic lipids. • Aligos is currently evaluating options to fund continued development, with plans to complete activities for a Phase IIb study by mid-2025.

Clinical Trial Shows Promise for Maralixibat in Treating ALGS-Related Cholestatic Pruritus

8 months ago

A phase IIb clinical trial, ICONIC, evaluated the safety and efficacy of maralixibat in children with Alagille Syndrome (ALGS), showing significant improvements in serum bile acid (sBA) levels and pruritus severity. The study, involving 31 patients aged 1 to 18 years, demonstrated maralixibat's potential as a treatment for cholestatic pruritus in ALGS patients, with notable reductions in sBA and improvements in quality of life measures.

FDA Accepts NDA for Oral Semaglutide 25 mg for Weight Management and Cardiovascular Risk Reduction

5 years ago

• The FDA has accepted the New Drug Application for oral semaglutide 25 mg, positioning it as a potential daily treatment option for both weight management and cardiovascular risk reduction. • If approved, oral semaglutide 25 mg would represent a significant advancement in GLP-1 receptor agonist therapy, offering patients a non-injectable alternative for obesity treatment. • The acceptance comes amid growing clinical interest in GLP-1 therapies, with this higher dose formulation potentially addressing the increasing demand for effective weight management solutions.