In a Phase 1 clinical study, researchers wanted to understand whether ALTB-268, developed by clinical-stage biotechnology company AltruBio Inc., could be effective in treating ulcerative colitis. The study first examined the therapy’s mechanism of action and biological activity in healthy individuals. According to a news release from AltruBio, positive topline data from the study is now available.
ALTB-268 is a second generation of ALTB-168. This subcutaneously administered multivalent PSGL-1 agonist antibody and immune checkpoint enhancer helps to balance the immune system. In ulcerative colitis, an unnatural immune response caused by overactivated (and chronically activated) T cells contributes to continued inflammation and ulceration. ALTB-268 targets these T cells, downregulating them and causing apoptosis (cell death) in some cells. In the past, there have been issues with therapies targeting the immune system. For example, attempting to downregulate certain cells or tamp down the body’s immune response is broader and more systemic, leading to other health issues.
Within the trial, researchers evaluated the therapy’s safety, pharmacokinetics, pharmacodynamics, tolerability, and immunogenicity. Immunogenicity is essentially how well a therapy can induce an immune response. The trial explored varying doses as well and identified an ideal dose for future studies. AltruBio reports that ALTB-268 was safe and well-tolerated in the healthy trial participants. The therapy did not have a strong immune suppressive response, allowing for a more targeted treatment path. It also showed more activity than its prior formulation (ALTB-168).
Moving forward, AltruBio plans on holding at least two additional clinical studies for ALTB-268. The first will focus on people with ulcerative colitis whose condition is refractory to biologic treatment, which means that their condition does not respond well to that treatment. Next year, the company also hopes to begin a Phase 2 study more focused on evaluating the therapy’s ideal dose.
Understanding Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that causes the large intestine to become damaged and inflamed. It occurs as the result of an overactive immune system. In short, the immune system (mistakenly) identifies a threat, activating and leading to the formation of sores and ulcers. But doctors believe that heredity and environmental factors may also play a role.
Ulcerative colitis is more common in people who have family members with IBD, those of Jewish heritage, young adults between ages 15 and 30, and people over 60 years old. Symptoms often develop over time. This means that you may not feel more intense symptoms until the condition has progressed. Without treatment, ulcerative colitis can lead to serious and even life-threatening complications. Treatment options include antibiotics and aminosalicylates, immunomodulators and biologics, and corticosteroids. Surgery may also be used in severe situations.
Symptoms of ulcerative colitis may include:
- Loose bowel movements
- Bloody stool
- Unintentional weight loss
- Feeling like you need to urgently pass a bowel movement
- Anemia (low red blood cell count)
- Fatigue
- Rapid heart rate
- Nausea
- Abdominal pain and cramping
- Joint pain
- Rashes
