iBio Initiates Non-Human Primate Study of First-in-Class Activin E Antibody Following Positive Preclinical Data Demonstrating Prevention in Weight Regain After GLP-1 Treatment

Rhea-AI Summary

iBio has initiated a non-human primate (NHP) study for IBIO-610, its first-in-class Activin E antibody candidate, following promising preclinical results. The study will evaluate pharmacokinetics and efficacy in obese, elderly NHPs, with initial data expected in early Q4. Preclinical data showed IBIO-610 achieved 8.9% body weight loss alone and demonstrated significant fat reduction capabilities: 26% overall fat reduction and 31% subcutaneous fat reduction. When combined with GLP-1 therapy, these numbers increased to 77% and 74% respectively. Notably, IBIO-610 prevented weight regain after GLP-1 treatment discontinuation in diet-induced obese mice. These findings will be presented at the American Diabetes Association's 85th Scientific Sessions on June 23rd in Chicago.

Positive

• IBIO-610 demonstrated 8.9% body weight loss in preclinical studies
• Showed 26% reduction in fat and 31% reduction in subcutaneous fat
• Combined with GLP-1, achieved up to 77% fat reduction
• Prevented weight regain after GLP-1 treatment discontinuation
• Initial NHP study data expected by early Q4

Negative

• Still in early preclinical stage, far from potential commercialization
• Results only demonstrated in animal studies, human efficacy yet to be proven

Insights

Biotech Research Analyst

iBio's novel Activin E antibody shows promising obesity treatment potential with fat-selective weight loss and prevention of post-GLP-1 weight regain.

iBio has initiated a non-human primate (NHP) study for IBIO-610, their first-in-class Activin E antibody candidate targeting obesity. The study will assess both pharmacokinetics (drug half-life) and early efficacy signals in obese, elderly NHPs, with initial data expected by early Q4.

The preclinical data package supporting this advancement is quite impressive. In diet-induced obese mice, IBIO-610 demonstrated 8.9% overall body weight reduction as a monotherapy. More significantly, it showed 26% fat reduction, which increased to 77% when combined with GLP-1 therapy. The antibody appears particularly effective against subcutaneous fat, showing 31% reduction alone and 74% reduction in combination with GLP-1.

What truly differentiates IBIO-610 from existing obesity treatments is its ability to prevent weight regain following GLP-1 discontinuation. This addresses a critical unmet need, as rapid weight rebound typically occurs when patients stop GLP-1 therapy - a significant clinical challenge referenced in the Wilding et al. study cited.

The company is preparing to present expanded preclinical data at the American Diabetes Association's Scientific Sessions on June 23rd. The strategic targeting of Activin E represents a novel mechanism of action in obesity treatment, potentially complementary to the highly successful GLP-1 class. If these preclinical results translate to humans, IBIO-610 could offer significant advantages either as monotherapy or as an adjunct to GLP-1s.

This study initiation represents a critical advancement in iBio's development pipeline, moving their candidate closer to potential human trials. The company has successfully scaled up production, suggesting preparation for larger studies and eventual clinical manufacturing.

iBio nominates IBIO-610 as development candidate for its first-in-class Activin E antibody

New study aims to evaluate the half-life of IBIO-610 in obese, elderly non-human primates (NHP) and assess early signs of efficacy on fat reduction and body composition

Mouse study shows IBIO-610 alone drives an overall body weight loss of 8.9%*, and prevents weight regain following GLP-1 treatment in obese mice, results of which will be presented at ADA on Monday June 23^rd

SAN DIEGO, June 16, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (Nasdaq: IBIO), an AI-driven innovator of precision antibody therapies, today announced the initiation of a NHP study for its Activin E engineered antibody candidate, now named IBIO-610. This preclinical study will evaluate the pharmacokinetics and early signs of efficacy of IBIO-610 in obese and elderly NHPs, including its impact on fat and body composition.

The study initiation follows a successful scale-up in production and encouraging preclinical results demonstrating a 26% reduction in fat, and synergistic effects with GLP-1 therapy in diet-induced obese (DIO) mice, where the fat-selective weight loss increased to 77%. Initial data from the NHP study are expected by early Q4.

The NHP study launch follows additional positive preclinical data to be presented at the American Diabetes Association's (ADA) 85^th Scientific Sessions, taking place June 20-23 in Chicago. This poster presentation expands on recent in vivo findings, which also demonstrated a significant 31% reduction in subcutaneous fat and increased to 74% reduction in subcutaneous fat when IBIO-610 was combined with a GLP-1 receptor agonist. The new data show IBIO-610 can not only enhance GLP-1-driven overall weight loss but also prevent weight-regain in DIO mice after GLP-1 therapy discontinuation. This is especially important, as the post-treatment period is typically marked by rapid weight rebound in humans¹.

“The promising preclinical data we've generated for this novel approach in the field of obesity are highly encouraging, especially regarding its ability to drive fat-selective weight loss and support long-term weight maintenance,” said Martin Brenner, DVM, Ph.D., Chief Executive Officer and Chief Scientific Officer of iBio. “With this non-human primate study underway and a key scientific presentation at ADA ahead, we are accelerating the path toward clinical development. IBIO-610 exemplifies our commitment to advancing novel, AI-guided antibody therapeutics for serious cardiometabolic conditions like obesity.”

*non-responder outliers removed

Details of the Poster Presentation at the ADA 85^th Scientific Sessions:

Poster Number: 1701-P

Abstract Title: Activin E-Blocking Antibody for Treatment of Metabolic Diseases

Date & Time: Monday, June 23, from 12:30 p.m. to 1:30 p.m. CST

Location: Poster Hall (Hall F1)

References

1. Wilding, J. P. H. et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes, Obesity and Metabolism 24, 1553–1564 (2022).

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

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the preclinical study evaluating the pharmacokinetics and early signs of efficacy of IBIO-610 in obese and elderly NHPs, including its impact on fat and body composition, receiving initial data from the NHP study by early Q4, presenting additional positive preclinical data at the American Diabetes Association's 85th Scientific Sessions on June 20-23 in Chicago, the ability of IBIO-610 to drive fat-selective weight loss and support long-term weight maintenance, accelerating the path toward clinical development and advancing novel, AI-guided antibody therapeutics for serious cardiometabolic conditions like obesity. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of IBIO-610 to drive fat-selective weight loss and support long-term weight maintenance; iBio’s ability to complete the preclinical study of IBIO-610 on time and achieve desired results and benefits as expected; 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

Media Contacts: 
Ignacio Guerrero-Ros, Ph.D., or David Schull 
Russo Partners, LLC 
Ignacio.guerrero-ros@russopartnersllc.com 
David.schull@russopartnersllc.com 
(858) 717-2310 or (646) 942-5604

FAQ

What is IBIO-610 and how does it work?

IBIO-610 is a first-in-class Activin E antibody candidate developed by iBio that targets fat reduction and prevents weight regain after GLP-1 treatment discontinuation.

What were the key results from IBIO's preclinical studies?

IBIO-610 achieved 8.9% body weight loss alone, 26% overall fat reduction, and when combined with GLP-1 therapy, increased to 77% fat reduction in preclinical studies.

When will IBIO-610's non-human primate study results be available?

Initial data from the non-human primate study are expected by early Q4 of 2025.

How does IBIO-610 complement GLP-1 treatments?

IBIO-610 enhances GLP-1-driven weight loss and prevents weight regain after GLP-1 therapy discontinuation, showing synergistic effects in combination therapy.

Where will IBIO present their latest research findings?

iBio will present their findings at the American Diabetes Association's 85th Scientific Sessions on June 23rd, 2025, in Chicago.