Phase 2a exploratory biomarker study in ulcerative colitis underway; Phase 2b placebo controlled clinical trial in the same indication on track to launch in 2024.

SAN FRANCISCO, CA, USA I December 07, 2023 IAltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced the first patient enrolled for the Phase 2a clinical study of the company’s subcutaneously administered immune checkpoint enhancer (ICE), ALTB-268 in ulcerative colitis (UC).

The company’s Phase 2 clinical program consists of a phase 2a open-label study in patients with biologic refractory UC and a phase 2b randomized, placebo-controlled study in patients with moderately to severely active UC.

“We are excited to reach this critical milestone, as we work to bring ALTB-268 to patients with autoimmune inflammatory disorders,” said Dr. Jesse Hall, Chief Medical Officer of AltruBio. “PSGL-1 is upregulated in several autoimmune diseases including UC. This Phase 2a study aims to identify potential biomarkers of ALTB-268 treatment. The unique mechanism of action for supports a truly differentiated therapeutic approach for inflammatory bowel disease.

In addition to the phase 2a study already underway in patients with biologics refractory disease, in 2024 the company aims to start a larger, global phase 2b randomized, placebo controlled study in patients with moderately to severely active UC. The phase 2b study will be open to both advanced therapy experienced and naïve patients.

About ALTB-268
ALTB-268 is a tetravalent PSGL-1 agonist antibody that acts as an immune checkpoint enhancer (ICE) to preferentially downregulate chronically activated T-cells by inhibiting the T-cell effector function, promoting T-cell exhaustion and apoptosis. ALTB-268 helps to restore the immune system to a state of balance without systemic suppression, and by treating immune diseases at their source. Its unique mechanism of action is the same as the bivalent intravenously administered ICE, ALTB-168, which has previously demonstrated promising Phase 2 results in ulcerative colitis, psoriasis, psoriatic arthritis, and SR/TR-aGVHD including improved patient outcomes and clinically meaningful efficacy. ALTB-268 exhibits increased potency in preclinical studies and is formulated for subcutaneous dosage for patient-friendly administration. A Phase 1 study evaluating the safety and tolerability of ALTB-268 in healthy volunteers showed no serious adverse events across all cohorts. A Phase 2 exploratory biomarker clinical study for ALTB-268 in biologics-refractory ulcerative colitis patients is anticipated to begin by end of 2023 and a randomized Phase 2 study in ulcerative colitis is planned to be initiated in 2024. Based on the relevance of T-cell modulation in many immunological diseases, ALTB-268 has broad expansion potential in different indications and hence has significant promise as a “pipeline-in-a-product.”

About AltruBio Inc.
AltruBio is a clinical-stage biotechnology company that specializes in developing novel therapies leveraging immune checkpoint agonism to enhance the function of natural pathways to downregulate an overactivated immune system. It is believed the mechanism of our immune checkpoint enhancers (ICEs) may hold the key to addressing the pressing medical needs of patients with autoimmune and inflammatory disorders. The company’s research team was the first to discover the novel role PSGL-1 plays as an important immune checkpoint regulator and leveraged its ability to downregulate chronic effector T-cell function and promote apoptosis and/or cell exhaustion. Robust clinical data validates proof of mechanism of our ICE therapy, ALTB-168, through enhancement of PSGL-1 function. ALTB-168 preferentially downregulates chronically activated late-stage T-cells in several diseases including ulcerative colitis, steroid refractory acute graft-versus-host disease (SR-aGVHD), psoriatic arthritis, and psoriasis, and was shown to be well tolerated with durable responses. Leveraging the same binding domain and novel mechanism demonstrated for ALTB-168, the company is advancing a more potent tetravalent ICE, ALTB-268, making it suitable for subcutaneous and patient-friendly administration. ​Led by an expert team with successful track records in drug development and commercialization in immunological diseases, AltruBio’s mission is to bring safer, more effective, and durable biologic treatments to improve the lives of patients.

SOURCE: AltruBio