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Altimmune Presents Results of a Phase 2 MRI-Based Body Composition Sub-Study at 60th Annual Meeting of the European Association for the Study of Diabetes

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Altimmune presented results from a Phase 2 MRI-based body composition sub-study of pemvidutide at the 60th Annual Meeting of the European Association for the Study of Diabetes. The study, involving 67 subjects from the MOMENTUM obesity trial, showed promising outcomes for pemvidutide, a novel GLP-1/glucagon dual receptor agonist:

1. Lean loss ratio of only 21.9%, indicating excellent preservation of lean mass.
2. Even better lean mass preservation in subjects aged 60+, with a lean loss ratio of 19.9%.
3. 25.6% reduction in visceral adipose tissue (VAT) at the 2.4mg dose, compared to 20.1% loss in subcutaneous adipose tissue.

These results suggest pemvidutide's potential in reducing fall and fracture risks, especially in older adults, while also lowering cardiovascular disease risk through VAT reduction.

Altimmune ha presentato i risultati di uno studio secondario basato su MRI di fase 2 sulla composizione corporea di pemvidutide durante il 60° Congresso Annuale dell'Associazione Europea per lo Studio del Diabete. Lo studio, che ha coinvolto 67 soggetti della verifica MOMENTUM sull'obesità, ha mostrato risultati promettenti per pemvidutide, un nuovo agonista duale del recettore GLP-1/glucagone:

1. Rapporto di perdita di massa magra di solo il 21,9%, indicando un'eccellente preservazione della massa magra.
2. Preservazione della massa magra ancora migliore nei soggetti di età superiore ai 60 anni, con un rapporto di perdita di massa magra del 19,9%.
3. Riduzione del 25,6% del tessuto adiposo viscerale (VAT) alla dose di 2,4 mg, rispetto al 20,1% di perdita del tessuto adiposo sottocutaneo.

Questi risultati suggeriscono il potenziale di pemvidutide nella riduzione del rischio di cadute e fratture, in particolare negli anziani, contribuendo anche a ridurre il rischio di malattie cardiovascolari attraverso la riduzione del VAT.

Altimmune presentó los resultados de un subestudio de composición corporal basado en MRI de fase 2 de pemvidutide en la 60ª Reunión Anual de la Asociación Europea para el Estudio de la Diabetes. El estudio, que involucró a 67 sujetos del ensayo de obesidad MOMENTUM, mostró resultados prometedores para pemvidutide, un nuevo agonista dual del receptor GLP-1/glucagón:

1. Proporción de pérdida de masa magra del solo 21,9%, indicando una excelente preservación de la masa magra.
2. Preservación de la masa magra aún mejor en sujetos mayores de 60 años, con una proporción de pérdida de masa magra del 19,9%.
3. Reducción del 25,6% del tejido adiposo visceral (VAT) a la dosis de 2,4 mg, en comparación con una pérdida del 20,1% en el tejido adiposo subcutáneo.

Estos resultados sugieren el potencial de pemvidutide para reducir el riesgo de caídas y fracturas, especialmente en adultos mayores, mientras también se disminuye el riesgo de enfermedades cardiovasculares a través de la reducción de VAT.

Altimmune은 제60회 유럽당뇨병학회 연례회의에서 pemvidutide의 2상 MRI 기반 체성분 하위 연구 결과를 발표했습니다. MOMENTUM 비만 시험에서 67명의 참여자를 포함한 이 연구는, 새로운 GLP-1/글루카곤 이중 수용체 작용제인 pemvidutide에 대한 유망한 결과를 보여주었습니다:

1. 약 21.9%의 근육 손실 비율, 이는 근육량의 훌륭한 유지력을 나타냅니다.
2. 60세 이상의 피험자에서는 더욱 뛰어난 근육량 유지로 19.9%의 근육 손실 비율을 보였습니다.
3. 2.4mg 용량으로 25.6%의 내장 지방량 감소 (VAT), 피하 지방량의 20.1% 손실과 비교됩니다.

이 결과는 pemvidutide가 낙상 및 골절 위험, 특히 노인에서의 위험을 줄이며, 내장 지방량 감소를 통해 심혈관 질환 위험을 낮추는 잠재력을 시사합니다.

Altimmune a présenté les résultats d'une étude secondaire basée sur l'IRM de phase 2 sur la composition corporelle du pemvidutide lors de la 60e réunion annuelle de l'Association européenne pour l'étude du diabète. L'étude, impliquant 67 sujets de l'essai MOMENTUM sur l'obésité, a montré des résultats prometteurs pour le pemvidutide, un nouvel agoniste dual du récepteur GLP-1/glucagon :

1. Taux de perte de masse maigre de seulement 21,9%, indiquant une excellente préservation de la masse maigre.
2. Préservation encore meilleure de la masse maigre chez les sujets de 60 ans et plus, avec un taux de perte de masse maigre de 19,9%.
3. Réduction de 25,6% du tissu adipeux viscéral (VAT) à la dose de 2,4 mg, contre 20,1% de perte du tissu adipeux sous-cutané.

Ces résultats suggèrent le potentiel du pemvidutide à réduire les risques de chutes et de fractures, en particulier chez les personnes âgées, tout en diminuant le risque de maladies cardiovasculaires grâce à la réduction du VAT.

Altimmune hat die Ergebnisse einer Phase-2-Studie zur Körperzusammensetzung, basierend auf MRI, von pemvidutide auf dem 60. Jahresmeeting der Europäischen Diabetesgesellschaft präsentiert. Die Studie, die 67 Probanden aus der MOMENTUM-Adipositas-Studie einbezog, zeigte vielversprechende Ergebnisse für pemvidutide, einen neuen dualen GLP-1/Glukagon-Rezeptoragonisten:

1. Gewichtsverlustquote von nur 21,9%, was auf eine hervorragende Erhaltung der fettfreien Masse hinweist.
2. Noch bessere Erhaltung der fettfreien Masse bei Probanden über 60 Jahren, mit einer Verlustquote von 19,9%.
3. 25,6% Reduktion des viszeralen Fettgewebes (VAT) bei der Dosis von 2,4 mg, im Vergleich zu einem Verlust von 20,1% im subkutanen Fettgewebe.

Diese Ergebnisse deuten auf das Potenzial von pemvidutide hin, das Risiko von Stürzen und Frakturen zu reduzieren, insbesondere bei älteren Menschen, während gleichzeitig das Risiko für Herz-Kreislauf-Erkrankungen durch die Reduktion von VAT gesenkt wird.

Positive
  • Pemvidutide showed a lean loss ratio of only 21.9%, indicating excellent preservation of lean mass
  • Better lean mass preservation in subjects aged 60+, with a lean loss ratio of 19.9%
  • 25.6% reduction in visceral adipose tissue (VAT) at the 2.4mg dose, potentially lowering cardiovascular disease risk
  • Pemvidutide demonstrated superior lean mass preservation compared to historical diet and exercise results
Negative
  • None.

Insights

The results from Altimmune's Phase 2 MRI-based body composition sub-study of pemvidutide are highly promising for the obesity treatment landscape. The 21.9% lean loss ratio indicates exceptional preservation of lean mass, which is important for maintaining metabolic health and physical function. Particularly noteworthy is the 19.9% lean loss ratio in subjects over 60, addressing a critical need in an age group vulnerable to frailty-related complications.

The 25.6% reduction in visceral adipose tissue (VAT) at the 2.4mg dose is significant, as VAT is strongly associated with cardiovascular risk. This preferential reduction of VAT over subcutaneous fat suggests pemvidutide may offer cardiovascular benefits beyond weight loss. These results position pemvidutide as a potentially best-in-class obesity treatment, offering quality weight loss that could translate to improved long-term health outcomes and reduced mortality risk.

Altimmune's pemvidutide data presents a compelling investment case in the rapidly growing obesity market. The drug's differentiated profile, particularly its lean mass preservation and VAT reduction, could lead to significant market share capture if approved. With obesity treatments like Wegovy and Mounjaro seeing blockbuster success, pemvidutide's potential entry could disrupt the market dynamics.

Investors should note that while these results are promising, Altimmune is still in Phase 2 trials, with significant regulatory hurdles ahead. However, positive data in this competitive space often leads to increased valuation and partnership opportunities. The company's focus on both obesity and MASH (metabolic dysfunction-associated steatohepatitis) provides multiple shots on goal, potentially reducing investment risk. This news could catalyze near-term stock appreciation and enhance Altimmune's position in the biotech sector.

The pemvidutide data represents a significant advancement in obesity treatment. The 21.9% lean loss ratio is remarkably low, suggesting superior muscle preservation compared to existing therapies. This is important for maintaining basal metabolic rate and preventing weight regain, a common challenge in obesity management.

The 19.9% lean loss ratio in patients over 60 is particularly impressive, addressing a critical need in geriatric medicine where muscle loss can lead to frailty and increased mortality. The 25.6% reduction in VAT is also clinically significant, as visceral fat is a key driver of metabolic syndrome and cardiovascular disease. If these results are replicated in larger trials, pemvidutide could become a preferred option for patients with high cardiovascular risk or those at risk of sarcopenia, offering a more tailored approach to obesity treatment.

Lean Loss Ratio of only 21.9%, representing class-leading preservation of lean mass

Maintenance of lean mass preservation in individuals over the age of 60, a population at risk for frailty-related falls and fractures

Visceral adipose tissue (VAT), a risk factor for cardiovascular disease, reduced by 25.6% at Week 48

GAITHERSBURG, Md., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented data from its Phase 2, MRI-based body composition sub-study of pemvidutide in subjects with overweight and obesity at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH).

In an MRI sub-study of 67 subjects from the Phase 2 MOMENTUM obesity trial, 50 of whom were treated with pemvidutide for 48 weeks, the lean loss ratio, defined as the change in lean mass compared to the change in total mass, was 21.9%. Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%. In addition to lean mass preservation, there was a preferential reduction of VAT, the adipose tissue associated with cardiovascular risk. At the 2.4mg dose of pemvidutide, VAT was reduced by 25.6% at Week 48 compared to a 20.1% loss in subcutaneous adipose tissue.

“Preservation of lean mass may reduce risk of falls and fractures, development of co-morbidities, and rates of all-cause mortality, particularly in individuals over the age of 60,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. “Given the breadth and diversity of the obesity patient population, there has been growing attention given to the quality of weight loss. Our data demonstrates pemvidutide’s class-leading lean mass preservation, superior to that reported historically with diet and exercise. The robust reductions in VAT would also be expected to be associated with a lower risk of cardiovascular disease.”

About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.

About Altimmune
Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com.

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Forward-Looking Statement
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov.

Company Contact:
Vipin Garg
President and Chief Executive Officer
Phone: 240-654-1450
ir@altimmune.com

Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Danielle.cantey@inizioevoke.com

Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com

Julia Weilman
Burns McClellan
Phone: 646-732-4443
jweilman@burnsmc.com


FAQ

What were the key findings of Altimmune's Phase 2 MRI-based body composition sub-study for pemvidutide (ALT)?

The key findings were a lean loss ratio of 21.9%, better lean mass preservation in subjects aged 60+ (19.9% lean loss ratio), and a 25.6% reduction in visceral adipose tissue at the 2.4mg dose of pemvidutide.

How does pemvidutide's lean mass preservation compare to other methods for ALT stock?

According to Altimmune, pemvidutide demonstrated class-leading lean mass preservation, superior to that reported historically with diet and exercise.

What potential benefits does pemvidutide (ALT) offer for older adults based on the Phase 2 study results?

Pemvidutide showed better lean mass preservation in subjects aged 60+, potentially reducing the risk of falls, fractures, and development of co-morbidities in this population.

How might the reduction in visceral adipose tissue (VAT) impact cardiovascular risk for pemvidutide (ALT) users?

The 25.6% reduction in VAT at the 2.4mg dose of pemvidutide is expected to be associated with a lower risk of cardiovascular disease.

Altimmune, Inc.

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