Upcoming trial to test experimental antibody therapy for Sjögren’s
IBI355, an antibody-based treatment, designed to block activity of key protein
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Innovent Biologics, a China-based biopharmaceutical company, is planning to launch a Phase 2 clinical trial testing its experimental therapy IBI355 in people with Sjögren’s disease.
The study will be conducted in China and is expected to launch in early 2027, according to a press release from Innovent and Spero Therapeutics, its newly announced partner in IBI355’s development. No details about the upcoming trial’s design were provided at this time.
“Sjögren’s disease and other autoimmune conditions impose significant burdens on patients worldwide, with many facing limited treatment options,” said Lei Qian, MD, PhD, chief research and development officer for general biomedicine at Innovent. “By combining Innovent and Spero’s immunology expertise and development commitment, we aim to accelerate the delivery of differentiated therapies to patients living with these chronic conditions.”
IBI355 aims to stop attacks, spare immune cells
Sjögren’s is an autoimmune disorder where the immune system mistakenly starts to attack the body’s own healthy tissues. It characteristically affects the salivary glands and tear ducts, leading to dry mouth and dry eye, but the disease can also affect other parts of the body, giving rise to a wide range of symptoms.
“It is one of the most common autoantibody-driven diseases, yet no approved therapies address its underlying systemic nature,” the release stated.
IBI355, also known as SP001 outside China, is a next-generation antibody-based therapy designed to block the activity of a signaling protein called CD40L. This protein is normally involved in the activation of several types of immune cells that are known to contribute to Sjögren’s.
By suppressing CD40L, IBI355 aims to dampen the disease-driving autoimmune attack without depleting levels of these immune cells, which are also important for defending the body against infections.
We view CD40L as a clinically validated pathway with broad applicability across several immune-mediated diseases.
The therapy has already been tested in early clinical trials, including two Phase 1 studies in healthy volunteers (NCT06110338; NCT06416787) and a Phase 1b trial in people with Sjögren’s (NCT06484855). Phase 1 studies are usually small and geared toward evaluating safety, while Phase 2 studies are larger and designed to look for signs that a treatment may be effective.
Under the newly announced partnership with Spero Therapeutics, Innovent retains rights to develop and sell IBI355 within Greater China, while Spero receives exclusive rights to develop and sell the therapy in the rest of the world. In return, Innovent will receive an upfront payment plus potential milestone payments totaling up to $1.1 billion.
“We are pleased to partner with Spero Therapeutics on IBI355 to advance the development of this CD40L-targeted approach,” Qian said. “Our shared goal is to bring meaningful new options to patients in need, wherever they are.”
Spero is planning to launch a Phase 2 trial next year testing IBI355 in people with IgG4-related disease, another autoimmune disorder with limited treatment options.
“This in-licensing transaction establishes the foundation of our new pipeline and positions Spero to pursue potentially transformative therapies for patients living with chronic, debilitating conditions,” said Esther Rajavelu, Spero’s president and CEO. “We view CD40L as a clinically validated pathway with broad applicability across several immune-mediated diseases.”
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