Altimmune, Inc. is a clinical stage biopharmaceutical company, which focuses on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The company's lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. The company was founded in 1997 and is headquartered in Gaithersburg, MD.
相关临床试验
22
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1997
进行中（未招募）
3
13.6%
已完成
16
72.7%
招募中
1
4.5%
终止
2
9.1%
暂无批准数据
- The alcohol-associated liver disease market across the 7MM was valued at USD 145 million in 2025, with the United States accounting for approximately 59% of the total market share. - No FDA-approved therapies currently exist that directly modify ALD disease progression, leaving liver transplantation as the only curative option for end-stage disease. - Bausch Health's larsucosterol, holding FDA Fast Track and Breakthrough Therapy designations, entered Phase III trials in early 2026 with topline results expected in 2028 and potential approval by early 2029. - Emerging pipeline candidates including GSK4532990 (GSK), INT-787 (Alfasigma), Pemvidutide (Altimmune), and NTR-101 (Nterica) are targeting metabolic dysfunction, inflammation, and fibrosis through diverse modalities such as RNAi, FXR agonism, and GLP-1/glucagon dual agonism.
- Altimmune announced that CEO Vipin Garg will step down effective January 1, 2026, with Chairman Jerry Durso assuming the CEO role as the company transitions to late-stage clinical development. - The leadership change coincides with the expected release of 48-week data from the Phase 2b IMPACT trial for pemvidutide before year-end, which will inform Phase 3 trial design. - Pemvidutide, a dual GLP-1/glucagon receptor agonist, has demonstrated meaningful reductions in liver inflammation and fibrosis with significant weight loss in MASH patients. - The company maintains a strong financial position with approximately $211 million in liquid assets as of September 2025, supporting operations through upcoming regulatory phases.
- Altimmune has appointed Linda M. Richardson as Chief Commercial Officer, effective September 16, 2025, bringing over 30 years of commercial experience in metabolic disease and hepatology. - Richardson's appointment comes as Altimmune prepares to initiate Phase 3 development of pemvidutide for MASH treatment, positioning the company for future commercial success. - The new CCO previously served as Chief Commercial Officer at Intercept Pharmaceuticals and held senior commercial roles at Sanofi, including Global Commercial Head of the GLP-1 program Lixisenatide. - Pemvidutide is a GLP-1/glucagon dual receptor agonist being developed for multiple indications including MASH, Alcohol Use Disorder, and Alcohol-associated Liver Disease.
- Altimmune's stock crashed over 60% after its Phase 2b IMPACT trial of pemvidutide for MASH showed mixed results, with strong MASH resolution but insufficient fibrosis improvement. - The drug achieved statistically significant MASH resolution in 59.1% of patients at 1.2 mg dose versus 19.1% on placebo, along with meaningful weight loss of up to 6.2%. - Despite meeting the primary endpoint, investors were disappointed by the lack of statistical significance in fibrosis reduction, a critical benchmark for MASH treatment success. - Altimmune plans to meet with the FDA for an End-of-Phase 2 meeting by late 2025 and is considering a Phase 3 trial, while analysts maintain a "Strong Buy" rating.
- D&D Pharmatech's DD01 achieved 75.8% of patients with at least 30% liver fat reduction in just 12 weeks, matching Boehringer Ingelheim's servodutide results that required 48 weeks of treatment. - The dual GLP-1/glucagon receptor agonist demonstrated superior tolerability with only 9.09% treatment discontinuation due to gastrointestinal side effects compared to 20% for competing drugs. - DD01 showed significant improvements in non-invasive MASH markers including liver stiffness and proC3 levels, with 48.5% of patients achieving normal liver fat levels within 12 weeks. - The drug's unique pharmacokinetic profile allows for rapid therapeutic dosing without lengthy titration periods, potentially offering advantages in clinical management of MASH patients.
- Altimmune has secured a $100 million credit facility from Hercules Capital, with $15 million funded immediately and additional tranches available upon meeting clinical and financial milestones. - The financing will support ongoing development of pemvidutide, a GLP-1/glucagon dual receptor agonist currently in Phase 2b trials for MASH, with top-line data expected in Q2 2025. - Altimmune plans to initiate Phase 2 trials for pemvidutide in Alcohol Use Disorder and Alcohol Liver Disease in the second and third quarters of 2025, expanding the drug's potential therapeutic applications.
• Altimmune announced plans to initiate Phase II trials of its GLP-1/glucagon agonist pemvidutide for alcohol use disorder in Q2 2025 and alcohol-related liver disease in Q3, expanding beyond obesity treatment. • The company's strategic expansion leverages pemvidutide's mechanism of action and the established connection between alcohol use and obesity in exacerbating liver damage. • Pemvidutide previously demonstrated 15.6% weight loss at its highest dose in the Phase II MOMENTUM obesity trial, with approximately 80% of weight loss coming from fat rather than lean muscle mass.
- Altimmune's intranasal COVID-19 vaccine AdCOVID showed insufficient immune response in Phase 1 trials, leading to the termination of the development program. - The company's nasal vaccine aimed to provide room-temperature stability and enhanced mucosal immunity, but failed to generate adequate antibody levels against SARS-CoV-2. - Following this setback, Altimmune will redirect its focus to ALT-801, its peptide drug candidate for NASH and obesity treatment.
- Altimmune's pemvidutide, currently in Phase II trials for obesity and metabolic dysfunction-associated steatohepatitis, is projected to reach $1.21 billion in sales by 2030. - Structure Therapeutics' GSBR-1290, an oral formulation in Phase II for obesity and type 2 diabetes, is forecasted to generate $1.2 billion in sales by 2030. - Viking Therapeutics, Altimmune, and Structure Therapeutics are emerging as potential disruptors in the GLP-1RA market, challenging the dominance of industry giants like Novo Nordisk and Eli Lilly.
- Altimmune and MindMed were added to the Nasdaq Biotechnology Index (NBI) on December 23, 2024, signaling recognition of their progress and potential. - Altimmune anticipates topline data from the Phase 2b IMPACT trial of pemvidutide for MASH in the second quarter of 2025, a key catalyst for the company. - MindMed is advancing its Phase 3 study of MM120 ODT for generalized anxiety disorder, with initial results expected in the latter half of 2025. - Both companies view their inclusion in the NBI as a validation of their efforts to deliver innovative treatments and long-term value to shareholders.
