Trending...
- Tampa-Based Digital Marketing Agency Launches New Website to Help Local Businesses Grow Online - 118
- California: Governor Newsom announces new tax credits that will generate $2.1 billion investment in world's 4th largest economy
- New PSA Campaign to Address Black Maternal and Infant Mortality in Los Angeles County
PALO ALTO, Calif., Sept. 12, 2023 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases, today announced its decision to discontinue the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD). The decision is based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review. In a communication dated September 7, 2023, the DSMB recommended the discontinuation of the LIMT-2 study due to observations of four patients with hepatobiliary events that resulted in liver decompensation.
"The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options," said David Apelian, MD, PhD, MBA, CEO of Eiger. "We will work closely with FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety."
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial that randomized patients with well-compensated CHD infection to one of two treatment groups: peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=105), or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=53). In July, the trial completed enrollment of 158 patients in 12 countries across 48 investigator sites.
More on The Californer
Dr. Apelian added, "As we look toward the future for Eiger, we will continue to execute on our strategic pivot, announced on June 29 of this year, and seek the financial resources required to advance the Company's development activities on avexitide in hyperinsulinemic hypoglycemia indications. We continue to evaluate strategic partnering options for our virology assets. Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda."
About Eiger
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger's lead product candidate, avexitide, is a well characterized, first-in-class GLP-1 antagonist for the treatment of post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from the FDA.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, prospective products, preclinical and clinical pipelines, regulatory objectives, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the timing of our ongoing and planned clinical development, including our development activities for avexitide in hyperinsulinemic hypoglycemia indications; our ability to secure financial resources required to advance avexitide in hyperinsulinemic hypoglycemia indications; our ability to identify, pursue and enter into partnering opportunities for our virology assets; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" section in Eiger's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
More on The Californer
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]
Media:
Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]
SOURCE Eiger BioPharmaceuticals, Inc.
"The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options," said David Apelian, MD, PhD, MBA, CEO of Eiger. "We will work closely with FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety."
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial that randomized patients with well-compensated CHD infection to one of two treatment groups: peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=105), or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=53). In July, the trial completed enrollment of 158 patients in 12 countries across 48 investigator sites.
More on The Californer
- California: Governor Newsom announces appointments 5.8.25
- Long Beach Parks, Recreation and Marine and Fire Department to Host Water Safety Day
- Terra Divine Skincare Earns Coveted Spot on Organically Becca's Clean Brand Master List
- NBA Champion Lamar Odom Launches Anti-Addiction Meme Coin, Ushering in a Disruptive Innovation in Web3
- Emmetra Partners with Renesas to Advance Agentic AI-Powered Imaging Solutions
Dr. Apelian added, "As we look toward the future for Eiger, we will continue to execute on our strategic pivot, announced on June 29 of this year, and seek the financial resources required to advance the Company's development activities on avexitide in hyperinsulinemic hypoglycemia indications. We continue to evaluate strategic partnering options for our virology assets. Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda."
About Eiger
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger's lead product candidate, avexitide, is a well characterized, first-in-class GLP-1 antagonist for the treatment of post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from the FDA.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, prospective products, preclinical and clinical pipelines, regulatory objectives, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the timing of our ongoing and planned clinical development, including our development activities for avexitide in hyperinsulinemic hypoglycemia indications; our ability to secure financial resources required to advance avexitide in hyperinsulinemic hypoglycemia indications; our ability to identify, pursue and enter into partnering opportunities for our virology assets; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" section in Eiger's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
More on The Californer
- Gravity to Bring 5-Minute EV Charging to 8 Sites Across Greater LA
- California: Governor Newsom issues statement on Pope Leo XIV, the first American Pope
- New poll shows high rates of employee burnout amid concerns over politics and personal finances
- Tessellations Appoints Luthern Williams as Head of School
- Aureli Construction Sets the Standard for Seamless Home Additions in Greater Boston
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]
Media:
Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]
SOURCE Eiger BioPharmaceuticals, Inc.
Filed Under: Business
0 Comments
Latest on The Californer
- California: Governor Newsom, Superintendent Thurmond announce over $618 million to support another 458 community schools
- California: Governor Newsom announces judicial appointments 5.7.25
- Long Beach to Commemorate its Naval History with Commemorative Community Event
- Long Beach: City Celebrates Inaugural National Home Improvement Month: Love Where You Live
- California sues Trump administration for illegally withholding billions in bipartisan infrastructure funds: 'Another Trump gift to China'
- Tale of two trains: California high-speed rail leaves Texas in the dust
- California: State invests nearly $33 billion in cap-and-trade dollars to make communities cleaner and healthier
- Where AI Falls Short, Real Connections Rise—Media Outreach with Heart
- Cybersecurity is Protecting Your Personal Information and Your Portfolio
- EY US unveils Puneet Nanda of GuruNanda as an Entrepreneur Of The Year® 2025 Award Finalist
- California: Governor Newsom proclaims Children's Mental Health Awareness Week 2025
- VC Mastermind Launches: A Private Global Network and Podcast for Top-Tier Venture Capital Leaders
- L2 Aviation Celebrates Grand Opening of New Facility at Cincinnati/Northern Kentucky International Airport (CVG)
- Actor and Writer Ernie Rivera Launches Groundbreaking Indie Superhero Thriller, Citadel Lost, with Full Campaign and Industry Buzz
- Managing Summer Staffing Surges with Confidence: Why Name Badges Are a Must for Seasonal Success
- Visa Named Title Sponsor of Ascending Athletes' Business Owners Summits for NFL Entrepreneurs
- The Paris Court of International Arbitration Elects Dr. John J. Maalouf as its New President
- ViroMissile Unveils IDOV™ Platform: A Potential One-Shot Cure for Cancer
- $56.7 Million Announced in Q1 2025 with Revenue Growth and Progress Toward NASDAQ Uplisting for AI Marketing Company: IQSTEL, Inc. Stock Symbol: IQSTD
- SAVVY MINING raised $500 million and launched BTC.XRP.DOGE cloud mining, increasing investors' returns by 30%