iBio Announces IBIO-600 Non-Human Primate Data Showing Extended Half-Life and Muscle Growth, and Interim In Vivo Results for First-in-Class Activin E Antibody, Advancing Cardiometabolic and Obesity Pipeline
iBio (NASDAQ: IBIO) has announced promising data for its lead asset IBIO-600, a novel long-acting anti-myostatin antibody. In non-human primate studies, IBIO-600 demonstrated a potential human half-life of 57-130 days, suggesting possible dosing schedules of once every 3-6 months.
The exploratory study in obese and elderly non-human primates showed dose-dependent increases in lean mass and reductions in fat mass. At 8 weeks, low-dose subjects (5 mg/kg) showed a 3.1% increase in lean mass, while high-dose subjects (50 mg/kg) demonstrated a 5.1% increase.
Additionally, iBio reported interim data for their first-in-class Activin E antibody. In combination with semaglutide, it enhanced total weight loss by an additional 9% beyond GLP-1 therapy alone, achieving 34% overall weight reduction and 72% body fat reduction. The company remains on track for IBIO-600's regulatory submission in Q1 2026.
iBio (NASDAQ: IBIO) ha annunciato dati promettenti per il suo principale asset IBIO-600, un nuovo anticorpo anti-myostatin a lunga durata d'azione. Negli studi su primati non umani, IBIO-600 ha dimostrato una potenziale emivita umana di 57-130 giorni, suggerendo possibili schemi di dosaggio di una volta ogni 3-6 mesi.
Lo studio esplorativo su primati non umani obesi e anziani ha mostrato aumenti della massa magra e riduzioni della massa grassa in funzione della dose. Dopo 8 settimane, i soggetti a bassa dose (5 mg/kg) hanno mostrato un aumento del 3,1% della massa magra, mentre i soggetti ad alta dose (50 mg/kg) hanno dimostrato un aumento del 5,1%.
Inoltre, iBio ha riportato dati intermedi per il loro anticorpo Activin E, primo della sua classe. In combinazione con semaglutide, ha migliorato la perdita di peso totale di un ulteriore 9% oltre alla terapia GLP-1 da sola, raggiungendo una riduzione complessiva del peso del 34% e una riduzione del 72% del grasso corporeo. L'azienda rimane in linea per la presentazione regolatoria di IBIO-600 nel primo trimestre del 2026.
iBio (NASDAQ: IBIO) ha anunciado datos prometedores para su activo principal IBIO-600, un novedoso anticuerpo anti-mioestatina de acción prolongada. En estudios con primates no humanos, IBIO-600 demostró una posible vida media humana de 57-130 días, lo que sugiere posibles esquemas de dosificación de una vez cada 3-6 meses.
El estudio exploratorio en primates no humanos obesos y ancianos mostró aumentos dependientes de la dosis en la masa magra y reducciones en la masa grasa. A las 8 semanas, los sujetos de baja dosis (5 mg/kg) mostraron un aumento del 3,1% en la masa magra, mientras que los sujetos de alta dosis (50 mg/kg) demostraron un aumento del 5,1%.
Además, iBio informó datos intermedios para su anticuerpo Activin E, el primero de su clase. En combinación con semaglutida, mejoró la pérdida total de peso en un 9% adicional más allá de la terapia GLP-1 sola, alcanzando una reducción del 34% en el peso total y una reducción del 72% en la grasa corporal. La empresa sigue en camino para la presentación regulatoria de IBIO-600 en el primer trimestre de 2026.
iBio (NASDAQ: IBIO)는 주요 자산 IBIO-600에 대한 유망한 데이터를 발표했습니다. IBIO-600은 새로운 장기 작용형 항-마이오스타틴 항체입니다. 비인간 영장류 연구에서 IBIO-600은 57-130일의 잠재적인 인간 반감기를 나타내어 3-6개월마다 한 번 복용할 수 있는 가능성을 시사했습니다.
비만 및 노령 비인간 영장류를 대상으로 한 탐색적 연구에서는 용량 의존적으로 근육량이 증가하고 지방량이 감소하는 결과가 나타났습니다. 8주 후, 저용량 그룹(5 mg/kg)은 근육량이 3.1% 증가했으며, 고용량 그룹(50 mg/kg)은 5.1% 증가했습니다.
또한, iBio는 첫 번째 클래스인 Activin E 항체에 대한 중간 데이터를 보고했습니다. 세마글루타이드와 함께 사용했을 때, GLP-1 치료만으로는 9%의 추가 체중 감소를 증가시켜 전체 체중 감소 34%와 체지방 감소 72%를 달성했습니다. 회사는 IBIO-600의 규제 제출을 2026년 1분기로 예정하고 있습니다.
iBio (NASDAQ: IBIO) a annoncé des données prometteuses pour son principal actif IBIO-600, un nouvel anticorps anti-myosatine à action prolongée. Dans des études sur des primates non humains, IBIO-600 a démontré une demi-vie humaine potentielle de 57 à 130 jours, suggérant des schémas posologiques possibles d'une fois tous les 3 à 6 mois.
L'étude exploratoire chez des primates non humains obèses et âgés a montré des augmentations de la masse maigre et des réductions de la masse grasse en fonction de la dose. Après 8 semaines, les sujets à faible dose (5 mg/kg) ont montré une augmentation de 3,1% de la masse maigre, tandis que les sujets à forte dose (50 mg/kg) ont démontré une augmentation de 5,1%.
De plus, iBio a rapporté des données intermédiaires pour son anticorps Activin E, premier de sa catégorie. En combinaison avec le sémaglutide, il a amélioré la perte de poids totale de 9% supplémentaires par rapport à la thérapie GLP-1 seule, atteignant une réduction globale de 34% du poids et une réduction de 72% de la graisse corporelle. L'entreprise reste sur la bonne voie pour la soumission réglementaire d'IBIO-600 au premier trimestre 2026.
iBio (NASDAQ: IBIO) hat vielversprechende Daten zu seinem Hauptprodukt IBIO-600 bekannt gegeben, einem neuartigen langwirksamen Anti-Myostatin-Antikörper. In Studien mit nicht-menschlichen Primaten zeigte IBIO-600 eine potenzielle menschliche Halbwertszeit von 57-130 Tagen, was mögliche Dosierungsschemata von einmal alle 3-6 Monate nahelegt.
Die explorative Studie an übergewichtigen und älteren nicht-menschlichen Primaten zeigte dosisabhängige Zuwächse an fettfreier Masse und Reduktionen an Fettmasse. Nach 8 Wochen zeigten die Niedrigdosis-Teilnehmer (5 mg/kg) einen Anstieg der fettfreien Masse um 3,1%, während die Hochdosis-Teilnehmer (50 mg/kg) einen Anstieg von 5,1% verzeichneten.
Zusätzlich berichtete iBio über Zwischenstände für ihren erstklassigen Activin E-Antikörper. In Kombination mit Semaglutid erhöhte er den Gesamtgewichtsverlust um weitere 9% über die GLP-1-Therapie hinaus und erreichte eine Gesamtreduzierung des Gewichts um 34% sowie eine Reduzierung des Körperfetts um 72%. Das Unternehmen bleibt auf Kurs für die regulatorische Einreichung von IBIO-600 im ersten Quartal 2026.
- Extended half-life of 57-130 days enables infrequent dosing (3-6 months)
- Demonstrated dose-dependent increase in lean mass (up to 5.1%) and fat reduction
- Activin E antibody showed strong synergistic effects with semaglutide (34% weight loss)
- Clear development timeline with regulatory submission planned for Q1 2026
- Non-human primate study not powered for statistical significance
- Results based on single administration only
- Early-stage data requiring further validation in human trials
Insights
iBio's announced preclinical data for IBIO-600 and their Activin E antibody represent significant advancements in their cardiometabolic and obesity pipeline. The NHP study for IBIO-600 revealed an impressive half-life of 40-52 days, with human half-life potentially reaching 57-130 days based on allometric scaling. This positions IBIO-600 as potentially best-in-class with a substantial competitive advantage - requiring only bi-annual dosing versus more frequent administration for competitors.
The dual mechanism showing both increased lean mass (up to 5.1% in high-dose groups) and reduced fat mass addresses a critical unmet need in obesity treatment, as current GLP-1 therapies often result in muscle loss alongside fat reduction. The first-in-class Activin E antibody data further strengthens iBio's position, demonstrating fat-selective weight loss as monotherapy and remarkable synergistic effects when combined with semaglutide - boosting total weight loss by an additional 9% beyond GLP-1 therapy alone, with 72% reduction in body fat.
While these are preclinical results requiring validation in human studies, the data suggests iBio has potentially differentiated assets in the highly competitive obesity market. The regulatory submission timeline for Q1 2026 indicates steady progress, though commercialization remains years away. The company has strategically positioned itself at the intersection of muscle preservation and weight management - a potentially lucrative market niche that addresses limitations of current therapies.
Non-human primate pharmacokinetics data suggests IBIO-600, a potentially best-in-class long-acting anti-myostatin antibody, could have a human half-life as long as 130 days
Additional interim in vivo data for a first-in-class Activin E antibody shows muscle sparing weight loss alone and in combination with a GLP-1 receptor agonist
iBio remains on track to submit a regulatory submission for IBIO-600 in Q1 2026
SAN DIEGO, April 07, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (Nasdaq: IBIO), an AI-driven innovator of precision antibody therapies, today announced data from a non-GLP non-human primate (NHP) pharmacokinetics (PK) study suggesting IBIO-600, the company’s novel lead asset and a potentially best-in-class long-acting anti-myostatin antibody designed for subcutaneous administration, could provide a significantly extended half-life in humans and a weight loss treatment option while preserving and promoting muscle growth.
The results were observed in a recently completed exploratory study in obese and elderly NHPs designed to analyze the potential of IBIO-600 in NHPs in order to closely mimic the human obese patient population by determining the antibody’s half-life in serum and evaluating changes in lean and fat mass. The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single administration in each case. In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass.
Despite the study not being powered to demonstrate statistical significance, and only having a single administration of the antibody, the results indicate IBIO-600 promoted a dose-dependent increase in lean mass and a reduction in fat mass from baseline values. The effect peaked after 8 weeks, when the NHPs receiving the low-dose had a
Standard PK calculations indicated the half-life of IBIO-600 in NHPs was 40 to 52 days. By using multiple allometric scaling approaches1,2, the half-life in humans of IBIO-600 has an estimated range of 57-130 days. This extended half-life could potentially enable a once every 3 to 6-month dosing schedule and positions IBIO-600 as a best-in-class therapeutic for muscle preservation and high-quality weight loss.
“The promising data suggest IBIO-600 could possibly exhibit the longest half-life among any other anti-myostatin candidates — potentially leading to best-in-class muscle preservation and growth with a significantly reduced dosing burden for patients with a few doses a year," said Martin Brenner, Ph.D., DVM, iBio’s CEO and Chief Scientific Officer. "IBIO-600’s extended half-life and muscle-building potential make it a transformative candidate for high-quality weight loss, further strengthening our expanding cardiometabolic and obesity pipeline. It is truly remarkable we’ve been able to advance this potentially best-in-class long-acting anti-myostatin antibody to clinical candidate selection in under a year and remain fully on track for a regulatory submission in Q1 2026. This incredibly rapid progress highlights our commitment to accelerating innovation and redefining obesity treatment with cutting-edge therapeutics.”
iBio is also pleased to announce preclinical data for a first-in-class Activin E antibody disclosed in January, highlighting its potential as a novel treatment for obesity. The antibody effectively blocks Activin E signaling in human adipocytes and is currently being evaluated in an exploratory study with obese mice, both as a monotherapy with bi-weekly dosing and in combination with semaglutide dosed daily. After only two weeks of dosing, monotherapy resulted in fat-selective weight loss of approximately
1 Genki Nakamura, Kazuhisa Ozeki, Miho Nagayasu, Takeru Nambu, Takayuki Nemoto, Ken-ichi Hosoya, Predicting Method for the Human Plasma Concentration–Time Profile of a Monoclonal Antibody from the Half-life of Non-human Primates, Biological and Pharmaceutical Bulletin, 2020, Volume 43, Issue 5, Pages 823-830, Released on J-STAGE May 01, 2020, Online ISSN 1347-5215, Print ISSN 0918-6158, https://doi.org/10.1248/bpb.b19-01042, https://www.jstage.jst.go.jp/article/bpb/43/5/43_b19-01042/_article/-char/en
About iBio, Inc.
iBio (Nasdaq: IBIO) is a cutting-edge biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer and other hard-to-treat diseases. By combining proprietary 3D modeling with innovative drug discovery platforms, iBio is creating a pipeline of breakthrough antibody treatments to address significant unmet medical needs. Our mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine. For more information, visit www.ibioinc.com or follow us on LinkedIn.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding non-human primate pharmacokinetics data suggesting IBIO-600, a potentially best-in-class long-acting anti-myostatin antibody, could have a human half-life as long as 130 days; remaining on track to submit a regulatory submission for IBIO-600 in Q1 2026; IBIO-600 providing a significantly extended half-life in humans and a weight loss treatment option while preserving and promoting muscle growth; the extended half-life potentially enabling a once every 3 to 6-month dosing schedule and positioning IBIO-600 as a best-in-class therapeutic for muscle preservation and high-quality weight loss; IBIO-600 possibly exhibiting the longest half-life among any other anti-myostatin candidates — potentially leading to best-in-class muscle preservation and growth with a significantly reduced dosing burden for patients with a few doses a year; IBIO-600’s extended half-life and muscle-building potential making it a transformative candidate for high-quality weight loss, further strengthening our expanding cardiometabolic and obesity pipeline; and the potential of Activin E inhibition as a transformative approach to obesity treatment, supporting further development and clinical advancement. While iBio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of IBIO-600 to have a half-life as long as 130 days; the ability of iBio’s innovative pipeline of therapeutics in cardiometabolic disease and obesity to promote healthy weight loss and muscle-building; and iBio’s ability to create a pipeline of breakthrough antibody treatments to address significant unmet medical needs; iBio’s ability to obtain regulatory approvals for commercialization of its product candidates, or to comply with ongoing regulatory requirements; regulatory limitations relating to iBio’s ability to promote or commercialize its product candidates for specific indications; acceptance of iBio’s product candidates in the marketplace and the successful development, marketing or sale of products; and whether iBio will incur unforeseen expenses or liabilities or other market factors; and the other factors discussed in iBio’s filings with the SEC including its Annual Report on Form 10-K for the year ended June 30, 2024 and its subsequent filings with the SEC on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and iBio undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Corporate Contact:
iBio, Inc.
Investor Relations
ir@ibioinc.com
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FAQ
What are the key findings from IBIO-600's non-human primate study?
When is IBIO's regulatory submission expected for IBIO-600?
What results did IBIO's Activin E antibody show in combination with semaglutide?
How frequently would IBIO-600 need to be administered based on trial data?
What weight loss results did IBIO's Activin E antibody show as monotherapy?
