IBIO-600 / iBio, AstralBio - LARVOL DELTA

Preclinical development of an extended half-life anti-myostatin monoclonal antibody. (PubMed, Sci Rep) - "In aged, obese cynomolgus monkeys, a single administration of IBIO-600 demonstrates an elimination half-life of approximately 52 days and produces sustained improvements in body composition. These findings support further development of IBIO-600 as a differentiated approach to enhance muscle preservation and improve the quality of weight loss achieved with GLP-1RA-based therapies."

Journal • Preclinical • Genetic Disorders • Obesity • TGFB1

iBio Becomes a Clinical-Stage Company with First Participant Dosed in Phase 1 Clinical Trial of IBIO-600 in Adults with Obesity (Yahoo Finance) - "First-in-human study of IBIO-600 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with obesity...Approximately 32 individuals are expected to enroll and will be monitored for approximately nine months following administration, with study completion expected in second half of 2027. Data from the study will help inform potential future development of IBIO-600."

First-in-human • P1 data • Trial status • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: iBio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Genetic Disorders • Obesity

iBio, Inc…announced IBIO-600 has received Clinical Trial Notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA) and ethics approval from a Human Research Ethics Committee (HREC), enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia. (The Manila Times) - "The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult participants. iBio expects to dose the first participant in the second quarter of 2026."

First-in-human • Trial status • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: iBio, Inc.

First-in-human • New P1 trial • Genetic Disorders • Obesity

Preclinical Evaluation of a Long-Acting Anti-Myostatin Therapy for Obesity (OBESITY WEEK 2025) - "These preclinical findings highlight the potential of IBIO-600 as a differentiated therapeutic for obesity, offering robust muscle preservation and enabling high quality weight loss. Its extended half-life may enable infrequent dosing, and its consistent effects across models support further clinical development."

Preclinical • Genetic Disorders • Obesity

iBio Announces Proposed Public Offering (GlobeNewswire) - "iBio intends to use the net proceeds received from the offering to advance its preclinical cardiometabolic programs, including IBIO-610, the myostatin and activin A bispecific, and IBIO-600 programs, through key development milestones, as well as to continue to progress its other preclinical pipeline assets, and the balance, if any, to fund iBio’s working capital requirements and for other general corporate purposes."

Financing • Obesity

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 (GlobeNewswire) - "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; 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."

New trial • Preclinical • Obesity