Global multi-arm Phase 2 clinical trial expected to launch in 2024

SAN FRANCISCO, CA, USA I September 26, 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 clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of the company’s subcutaneously administered immune checkpoint enhancer (ICE), ALTB-268 in ulcerative colitis.

“We’re thrilled to advance our subcutaneous ICE, ALTB-268 to Phase 2 trials as it’s a significant milestone of progressing our novel PSGL-1 agonist antibodies through the clinic and closer to patients in need,” said Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio. “Over the past year, AltruBio has demonstrated remarkable progress in achieving our clinical milestones, including successfully completing our Phase 1 trial and announcing positive topline data for ALTB-268. Notably, we were selected for an oral presentation as well as earned a Poster of Merit designation at the Federation of Clinical Immunology Societies Meeting. Our clinical data was also recognized with the prestigious Blue Ribbon Distinguished Poster Award at this year’s Crohn’s and Colitis Congress, a testament to the promise of ICEs to address diseases like ulcerative colitis. With the momentum we’ve garnered and the strong backing of the scientific community and renowned KOLs, we have the utmost confidence in our innovative approach that naturally restores immune balance, treating immune disorders at their source. We look forward to initiating studies in patients with ulcerative colitis by the end of 2023.”

The Phase 2 trials consist of an open-label exploratory biomarker clinical trial of ALTB-268 in patients with biologics-refractory ulcerative colitis and a randomized global multi-arm study evaluating two active doses of ALTB-268 (high and low) with placebo. The exploratory biomarker study is expected to start by the end of 2023 and the randomized study is expected to enroll patients in 2024.

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