iBio Targets First-Quarter Myostatin Data, Activin E Dosing as It Advances Obesity Pipeline

Key Points

• Two clinical milestones are approaching: iBio expects first-quarter data from its Phase 1 myostatin inhibitor IBIO-600, including safety and half-life results, and plans to begin dosing in its Activin E antibody study during the same period.
• The early Activin E study will focus on safety and pharmacokinetics, while also exploring body composition; it is not designed to establish weight loss. iBio sees potential use alongside GLP-1 drugs or for weight maintenance, but those benefits remain unproven.
• iBio says its cash runway extends into the second quarter of 2028 and should fund several near-term development milestones. Executives may consider raising capital or partnering assets after clinical data become available.

iBio NASDAQ: IBIO expects to report initial data from its clinical-stage myostatin program in the first quarter of the next calendar year and begin dosing patients in a separate Activin E study during the same period, executives said at the Guggenheim Healthcare Innovation Conference.

Chief Financial Officer Felipe Duran said the company became clinical-stage during the year and has cash to fund operations into the second quarter of 2028. He said iBio expects to consider raising capital sometime in the next year.

Activin E Study to Focus on Safety

Chief Executive Officer and Chief Scientific Officer Martin Brenner said iBio plans to file in Australia for a first-in-human study of IBIO-610, its Activin E antibody, by year-end. The company anticipates initial human data in the first half of the following year.

The Phase 1a study will primarily assess safety and pharmacokinetics, or how the drug moves through the body, Brenner said. Researchers also plan to examine pathway inhibition and body composition in patients with obesity, although the trial will not be long enough to establish whether the treatment produces weight loss.

Brenner said non-human primate data presented at the European diabetes meeting showed that adding an Activin E treatment to a GLP-1 shifted weight loss toward fat rather than muscle. Further body-weight data from the 28-week monkey study were scheduled for presentation shortly after the conference.

The CEO said iBio sees the greatest potential for IBIO-610 in combination with a GLP-1 or as a weight-maintenance treatment. He also described a possible limited role as a stand-alone therapy for patients who may be vulnerable to muscle loss. Those uses remain unproven.

Myostatin Readout Planned

iBio has completed dosing in the single-ascending-dose portion of its Phase 1 study of IBIO-600, a long-acting inhibitor of myostatin and GDF11, Brenner said. The first-quarter readout is expected to include safety and half-life data, and could include body-composition findings if they show a directional effect.

Brenner said the study data had not yet been unblinded, but that adverse effects observed so far had been benign. He identified the drug’s dual inhibition and potential long half-life as its main differentiators and said iBio is interested in patients who need to lose fat but cannot afford to lose muscle.

Earlier Programs and Funding Plans

For IBIO-800, a myostatin and Activin A bispecific antibody, iBio is pursuing pulmonary hypertension associated with heart failure with preserved ejection fraction, or PH-HFpEF, as an initial indication. Brenner said the company is conducting manufacturing and safety work and expects animal-model data around the end of the second quarter next year, close to its planned Australian submission to begin Phase 1 testing.

He said the company hopes the candidate could offer a safer approach than existing treatments, but acknowledged that the program remains early and that safety studies are ongoing.

iBio is also developing antibody-based amylin candidates with different receptor profiles. Brenner said the company hopes to select a development candidate around the middle of next year, followed by an estimated nine to 12 months of manufacturing and toxicology work before entering the clinic.

Duran said iBio will weigh raising capital against partnering individual assets after Phase 1 data become available. He added that the company’s current cash runway is expected to support the myostatin readout, interim Activin E and IBIO-800 data, and advancement of the amylin program through manufacturing and toxicology.

About iBio (NASDAQ:IBIO)

iBio, Inc. NASDAQ: IBIO is a biotechnology company focused on discovering and developing next-generation antibody therapeutics. The company uses artificial intelligence, machine learning and computational biology to identify and optimize antibody candidates for potential use in cancer and other serious diseases. iBio's discovery capabilities are built around proprietary antibody-design and profiling technologies, including platforms intended to improve the speed and quality of therapeutic antibody development.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.