iBio and AstralBio Provide Update on Myostatin Program for Obesity
iBio and AstralBio have provided an update on their joint myostatin program for cardiometabolic disease and obesity. The companies have identified a lead molecule with potential for extended half-life and subcutaneous dosing. This molecule is designed to treat muscle wasting and obesity, with plans to advance into non-cGMP in vivo studies in rodents and non-human primates. Potential early readouts from NHP studies are expected in early 2025.
The collaboration aims to develop a best-in-class myostatin inhibitor focusing on high potency and extended half-life. iBio has the option to license three cardiometabolic targets from AstralBio and aims to file an IND application by the end of 2025 if it exercises the option for the myostatin program.
iBio e AstralBio hanno fornito un aggiornamento sul loro programma congiunto riguardante il miostatina e le malattie cardiometaboliche e l'obesità. Le aziende hanno identificato una molecola leader con potenziale per una durata prolungata dell'emivita e dosaggio subcutaneo. Questa molecola è progettata per trattare la perdita di massa muscolare e l'obesità, con piani per progredire verso studi in vivo non-cGMP su roditori e primati non umani. Si prevedono potenziali primi risultati dagli studi sui NHP all'inizio del 2025.
La collaborazione mira a sviluppare un inibitore della miostatina di classe superiore concentrandosi su alta potenza e durata dell'emivita prolungata. iBio ha l'opzione di licenziare tre obiettivi cardiometabolici da AstralBio e intende presentare una domanda IND entro la fine del 2025 se eserciterà l'opzione per il programma sulla miostatina.
iBio y AstralBio han proporcionado una actualización sobre su programa conjunto de miostatina para enfermedades cardiometabólicas y obesidad. Las compañías han identificado una molécula principal con potencial para una vida media prolongada y dosificación subcutánea. Esta molécula está diseñada para tratar la pérdida de masa muscular y la obesidad, con planes de avanzar hacia estudios in vivo no cGMP en roedores y primates no humanos. Se esperan posibles resultados iniciales de los estudios en NHP a principios de 2025.
La colaboración tiene como objetivo desarrollar un inhibidor de miostatina de clase mundial enfocándose en alta potencia y vida media prolongada. iBio tiene la opción de licenciar tres objetivos cardiometabólicos de AstralBio y planea presentar una solicitud de IND para finales de 2025 si ejerce la opción para el programa de miostatina.
iBio와 AstralBio는 심혈관 대사 질환 및 비만에 대한 공동 미오스타틴 프로그램에 대한 업데이트를 제공했습니다. 두 회사는 장기간 반감기 및 피하 투여가 가능한 주요 분자를 발견했습니다. 이 분자는 근육 소모 및 비만을 치료하도록 설계되었으며, 설치류 및 비인간 영장류에서 비 cGMP in vivo 연구로 발전할 계획입니다. NHP 연구에서의 초기 결과는 2025년 초에 예상됩니다.
협력의 목표는 높은 효능과 장기간 반감기를 중심으로 한 최고의 미오스타틴 억제제를 개발하는 것입니다. iBio는 AstralBio로부터 세 가지 심혈관 대사 목표를 라이센스 할 수 있는 옵션이 있으며, 미오스타틴 프로그램에 대한 옵션을 행사할 경우 2025년 말까지 IND 신청서를 제출할 계획입니다.
iBio et AstralBio ont fourni une mise à jour sur leur programme conjoint concernant la myostatine pour les maladies cardiométaboliques et l'obésité. Les entreprises ont identifié une molécule principale avec un potentiel pour une demi-vie prolongée et une administration sous-cutanée. Cette molécule est conçue pour traiter la perte musculaire et l'obésité, avec des plans pour avancer vers des études in vivo non cGMP sur des rongeurs et des primates non humains. Des résultats préliminaires des études sur les NHP sont attendus début 2025.
La collaboration vise à développer un inhibiteur de myostatine de premier ordre axé sur une haute puissance et une demi-vie prolongée. iBio a la possibilité de licencier trois cibles cardiométaboliques auprès d'AstralBio et prévoit de déposer une demande IND d'ici la fin 2025 si elle exerce l'option pour le programme de myostatine.
iBio und AstralBio haben ein Update zu ihrem gemeinsamen Myostatin-Programm für kardiometabolische Erkrankungen und Fettleibigkeit bereitgestellt. Die Unternehmen haben ein Leitmolekül identifiziert, das das Potenzial für verlängerte Halbwertszeit und subkutane Dosierung hat. Dieses Molekül wurde entwickelt, um Muskelabbau und Fettleibigkeit zu behandeln, und plant, in nicht-cGMP in vivo Studien an Nagetieren und nicht-menschlichen Primaten voranzuschreiten. Frühe Ergebnisse aus den NHP-Studien werden für Anfang 2025 erwartet.
Die Zusammenarbeit zielt darauf ab, einen best-in-class Myostatin-Inhibitor zu entwickeln, der sich auf hohe Potenz und verlängerte Halbwertszeit konzentriert. iBio hat die Option, drei kardiometabolische Ziele von AstralBio zu lizenzieren und plant, einen IND-Antrag bis Ende 2025 einzureichen, wenn es die Option für das Myostatin-Programm ausübt.
- Identification of a lead molecule with potential extended half-life and subcutaneous dosing
- Plans to advance into non-cGMP in vivo studies with potential early readouts in early 2025
- Option to license three cardiometabolic targets from AstralBio
- Potential IND application filing by the end of 2025 if option is exercised
- Program is still in early stages of development
- No guarantee of successful outcomes in planned studies or IND approval
Insights
The collaboration between iBio and AstralBio on the myostatin program represents a potentially significant development in the field of obesity and cardiometabolic disease treatment. The identification of a lead molecule with an extended half-life and subcutaneous dosing capability could address key challenges in current therapies.
Key points to consider:
- The potential for subcutaneous administration could improve patient compliance and reduce healthcare costs compared to intravenous options.
- An extended half-life may allow for less frequent dosing, further enhancing patient convenience and potentially improving treatment adherence.
- The timeline for non-human primate studies in early 2025 and a potential IND filing by the end of 2025 suggests a relatively rapid development path.
However, investors should note that the program is still in early stages and success in preclinical studies does not guarantee clinical efficacy or regulatory approval. The obesity market is highly competitive, with several large pharmaceutical companies already having established products or advanced pipeline candidates.
For iBio, with a market cap of
The obesity treatment market presents a substantial opportunity, with global projections reaching
Key market considerations:
- The focus on subcutaneous administration aligns with market trends favoring patient-friendly delivery methods.
- An extended half-life product could compete effectively against frequent-dosing regimens of current therapies.
- The dual benefit of increasing muscle mass and boosting metabolism could appeal to a broad patient population, potentially expanding the addressable market.
However, the program faces significant hurdles:
- Established players like Novo Nordisk and Eli Lilly have a strong market presence with proven GLP-1 therapies.
- The timeline to market is long, with potential commercialization not likely before 2028-2029, assuming successful clinical trials.
- Funding for a small-cap company like iBio to complete clinical development may be challenging in the current economic environment.
Investors should view this as a high-risk, high-reward opportunity with significant time to potential commercialization.
Lead molecule identified with potential extended half-life and subcutaneous dosing
SAN DIEGO, Oct. 10, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO), an AI-driven innovator of precision antibody immunotherapies, today provided an update on the myostatin program for cardiometabolic disease and obesity in collaboration with AstralBio. iBio’s technology stack enabled the Company to rapidly advance the joint myostatin program from inception to in vitro proof-of-concept in human muscle cells. Following early discovery, the companies have identified a molecule with therapeutic potential for treating muscle wasting and obesity, which is designed for subcutaneous administration and has potential for an extended half-life. The companies are currently working on plans to advance this molecule into non-cGMP in vivo studies in rodents and non-human primates (NHP) with potential early readouts of the NHP in early 2025.
"Myostatin inhibitors hold great promise for treating obesity and cardiometabolic diseases by increasing muscle mass and boosting metabolism," said Martin Brenner, Ph.D., DVM, iBio’s CEO and Chief Scientific Officer. "However, a best-in-class approach is essential to ensure the next generation of myostatin therapies can effectively address the needs of a large population of obese patients. This means focusing on two critical aspects: high potency and an extended half-life. While our work is still in the early stages, we are optimistic our novel molecule could overcome some of these challenges by offering an alternative to intravenous administration and a treatment paradigm with less frequent dosing."
As part of the collaboration, iBio has the exclusive option to license three cardiometabolic targets from AstralBio and will receive the rights to develop, manufacture and commercialize those targets upon exercise. In the event iBio triggers the option to in-license the myostatin program, its goal is to file an Investigational New Drug (IND) application by the end of 2025.
“iBio’s AI-powered platform is an innovative tool for discovering and engineering potential new therapies, and we’re eager to use it in our shared mission to treat cardiometabolic diseases. By focusing on the TGFβ superfamily, including myostatin, we believe we can efficiently advance therapies that address conditions like obesity and muscle wasting,” said Patrick Crutcher, CEO of AstralBio. “By leveraging iBio’s expertise and team, we have built differentiated antibodies incorporating Fc-engineering to enable half-life extended therapeutics that could be potentially best-in-class. We are thrilled with the progress made on this program and look forward to advancing it further.”
About iBio, Inc.
iBio is an AI-driven innovator that develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers, and other diseases. iBio’s mission is to decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets. For more information, visit www.ibioinc.com.
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 statement regarding the identification of a lead molecule with potential extended half-life and subcutaneous dosing; the identification of a molecule with therapeutic potential for treating muscle wasting and obesity; plans to advance the molecule into non-cGMP in vivo studies in rodents and non-human primates (NHP) with potential early readouts of the NHP in early 2025; myostatin inhibitors holding great promise for treating obesity and cardiometabolic diseases by increasing muscle mass and boosting metabolism; the novel molecule overcoming some challenges by offering an alternative to intravenous administration and a treatment paradigm with less frequent dosing; filing an Investigational New Drug (IND) application by the end of 2025 in the event iBio triggers the option to in-license the myostatin program; iBio’s AI-powered platform discovering and engineering potential new therapies; iBio efficiently advancing therapies that address conditions like obesity and muscle wasting; and the differentiated antibodies built that incorporate Fc-engineering being potentially best-in-class. While the Company 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 Company’s ability to develop a best-in-class lead molecule with an extended half-life and subcutaneous dosing that treats muscle wasting and obesity; the ability to advance the molecule into non-cGMP in vivo studies in rodents and non-human primates (NHP) with early readouts of the NHP in early 2025; the ability to file an IND by the end of 2025 in the event that iBio triggers the in-licensing option; and the ability of the molecule to overcome some challenges by offering an alternative to intravenous administration and a treatment paradigm with less frequent dosing; and the other factors discussed in the Company’s filings with the SEC including the Company’s Annual Report on Form 10-K for the year ended June 30, 2024. The information in this release is provided only as of the date of this release, and the Company 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.
Contact:
iBio, Inc.
Investor Relations
ir@ibioinc.com
Susan Thomas
iBio, Inc.
Media Relations
susan.thomas@ibioinc.com
FAQ
What is the latest update on iBio's myostatin program for obesity?
When does iBio expect early readouts from the non-human primate studies for its myostatin program?
What is iBio's target date for filing an IND application for the myostatin program?
How many cardiometabolic targets does iBio have the option to license from AstralBio?
