This finding resulted from a preclinical study that was the subject of a poster presentation titled, “Anti-inflammatory properties of recombinant human alpha-fetoprotein (rhAFP) in the model of TNBS-induced colitis,” presented at the World Congress of Gastroenterology 2017, held in collaboration with The American College of Gastroenterology in Orlando, Florida.
The protein hAFP is produced only by embryos during fetal development. It has the ability to regulate the immune responses of the mother, protecting the embryo from harmful attacks from the mother’s immune cells.
During pregnancy, women with autoimmune disorders, including myasthenia gravis and multiple sclerosis, can present signs of disease remission, an effect that’s been associated with the rise and fall of hAFP levels. This observation suggests the protein may hold potential as an immune modulator for autoimmune illnesses.
A previous clinical study tested the therapeutic effects of hAFP compared to a placebo in 78 patients with IBD.
This study showed that daily administration of hAFP for 30 days could significantly reduce disease symptoms, colonic inflammation and ulcerative lesions.
In addition, Phase 1 and 2 clinical studies in other diseases or disorders involving more than 300 patients have demonstrated that administration of hAFP is as safe as a placebo.
Researchers at Intestinal Biotech Development of Lille Medical School in France conducted a preclinical study to assess the efficacy of ACT-101 compared to currently used anti-TNFα therapies, such as Humira (adalimumab) and Remicade (infliximab), in a mouse model of induced colitis.
Daily administration of ACT-101 was able to significantly reduce bowel inflammation by 53% in the mice compared to placebo. Its anti-inflammatory effects were more effective than those observed with anti-TNFα therapy, which only achieved a reduction in inflammation of about 45% compared to placebo.
“ACT-101 seems to be a very promising compound. Indeed, ACT-101 showed very high anti-inflammatory activity in the gold standard model of colitis,” Dr. Christel Rousseaux, lead investigator of the study, said in a press release.
A profile analysis of gene levels confirmed that treatment with ACT-101 could induce the production of anti-inflammatory proteins such as IL-10 while reducing pro-inflammatory proteins such as TNFα, IL-1b, IFN-gamma, and IL-6.
No significant toxic adverse side effects were observed with ACT-101, demonstrating a safety profile consistent with that reported in previous clinical studies.
“These results provide strong evidence of ACT-101 ability to reduce autoimmune inflammation safely and without typical side effects of currently used treatment modalities, such as immunosuppressive drugs or steroids,” said Dr. Igor Sherman, CEO of ACT. “We are continuing our development efforts to make this novel therapy for autoimmune diseases available to patients as soon as possible.”
These preclinical data, along with previous clinical trial results, support the development of ACT-101 as a potentially safe therapeutic option for the treatment of IBD patients with similar or greater effectiveness than anti-TNFα therapies
ACT is currently planning a follow-up study to evaluate the viability of an oral formulation of ACT-101 for the treatment of chronic IBD.
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