trichuris suis ova (CNDO-201) / Fortress - LARVOL DELTA

Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova: A Randomized, Double-blinded, Placebo-controlled Clinical Trial (the PROCTO Trial). (PubMed, J Crohns Colitis) - "Compared to placebo, Trichuris suis ova was not superior in achieving clinical remission at week 24 in ulcerative colitis or in achieving clinical Mayo score reduction, complete corticosteroid-free clinical remission or endoscopic remission. However, Trichuris suis ova treatment induced symptomatic temporary remission at week 12."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL ON EFFICACY AND SAFETY OF PROBIOTIC TREATMENT WITH TRICHURIS SUIS OVA IN PATIENTS WITH ULCERATIVE COLITIS (DDW 2023) - "This is the first randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of TSO in moderately active UC patients after 24 weeks of treatment. Consistent with previous findings, TSO induced symptomatic remission after 12 weeks of treatment in CSF patients, but the symptomatic remission was found to be transient. The TSO treatment was not superior compared to placebo in achieving either symptomatic remission or clinical remission of UC at week 24."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PROBIOTIC TREATMENT OF ULCERATIVE COLITIS WITH TRICHURIS SUIS OVA: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED CLINICAL TRIAL (UEGW 2022) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PROBIOTIC TREATMENT OF ULCERATIVE COLITIS WITH TRICHURIS SUIS OVA: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED CLINICAL TRIAL (UEGW 2022) - P2 | "Compared to placebo, TSO treatment was not superior in achieving clinical remission at week 24 in moderate UC patients or in achieving i) clinical MS reduction, ii) complete steroid-free clinical remission or endoscopic remission at week 24 compared to placebo. However, TSO treatment induced symptomatic remission at week 12 but not at week 24 and improved partial MS over time. Of notice, the study may be compromised by a high placebo effect and exposure to corticosteroids."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PROCTO: Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) (clinicaltrials.gov) - P2 | N=119 | Completed | Sponsor: ParaTech A/S | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PROCTO: Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) (clinicaltrials.gov) - P2; N=119; Active, not recruiting; Sponsor: ParaTech A/S; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and tolerability of medicinal parasite ova (Trichuris suis) in healthy Japanese volunteers: A randomized, double-blind, placebo-controlled trial. (PubMed, Parasitol Int) - "Healthy Japanese people tolerated all doses of TSO without any severe adverse events. On the other hand, mild to moderate abdominal symptoms were observed in several participants. This study suggested that the medicinal use of TSO in Japan is relatively safe, and close follow-up is recommended for sustainable usage."

Clinical • Journal • Allergy • Anorexia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Randomized Crossover Feasibility Trial of Helminthic Trichuris Suis Ova vs. Placebo for Repetitive Behaviors in Adult Autism Spectrum Disorder. (PubMed, World J Biol Psychiatry) - P1 | "This proof-of-concept study demonstrates the feasibility of TSO for the treatment of ASD, including a favorable safety profile, and moderate to large effect sizes for reducing repetitive behaviors and irritability."

Clinical • Journal • Allergy • Autism Spectrum Disorder • Food Hypersensitivity • Genetic Disorders • Immune Modulation • Immunology • Inflammation

The Worm-Specific Immune Response in Multiple Sclerosis Patients Receiving Controlled Trichuris suis Ova Immunotherapy. (PubMed, Life (Basel)) - "Using a T. suis antigen-specific T cell expansion assay, we also detected patient-to-patient variation of antigen-specific T cell recall responses and cytokine production. In summary, MS patients receiving TSO treatment established a T. suis-specific T- and B-cell response, however, with varying degrees of T cell responses and cellular functionality across individuals, which might account for the overall miscellaneous clinical efficacy in the studied patients."

Clinical • Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • CD4 • FOXP3 • GATA3

Pre-clinical evaluation of the effect of co-medication with antibiotics and oral steroids in Göttingen Minipigs on the biological activity of the probiotic medicinal product TSO (Trichuris suis ova). (PubMed, Parasitol Res) - "The probiotic medicinal product TSO (Trichuris suis ova) is administered to patients with active ulcerative colitis in an ongoing clinical phase IIb trial where the typical co-medications are steroids (prednisolone or budesonide) and antibiotics (e.g., phenoxymethylpenicillin). The biological activity of TSO was not affected by oral steroids but was reduced by oral antibiotics. Fecal calprotectin, the common marker of intestinal inflammation in patients with UC, did not differ between groups."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Effects of the dietary fibre inulin and Trichuris suis products on inflammatory responses in lipopolysaccharide-stimulated macrophages. (PubMed, Mol Immunol) - "Consumption of fermentable dietary fibres, such as inulin, or administration of helminth products (e.g. Trichuris suis ova) have independently been shown to alleviate inflammation in vivo...In contrast, inulin had little capacity to directly modulate LPS-induced responses. Our results suggest distinct mode-of-actions of T. suis and inulin in regulating inflammatory responses, and that the role of inulin in modulating the response to helminth infection may be dependent on other factors such as production of metabolites by the gut microbiota."

Journal • Immunology

Helminth Therapy - From the Parasite Perspective. (PubMed, Trends Parasitol) - "Here we examine the notion that, because of the complexity of biological symbiosis, intact helminths rather than helminth-derived products are likely to prove more useful for clinical purposes. Further, weighing potential cost/benefit ratios of various helminths along with other factors, such as feasibility of production, we argue that the four helminths currently in use for CIAD treatments in humans were selected more by happenstance than by design, and that other candidates not yet tested may prove superior."

Journal • Review

Move over probiotics, Coronado Biosciences has 'Proparasites' (SeekingAlpha) - Coronado announced plans to begin a P2b trial in Crohn's involving around 200 pts in 2Q 2012; Report European (Falk) P2 Crohn's study in 1Q 2013; Report US P2b Crohn's study in mid 2013

Anticipated P2b trial initiation • Inflammatory Bowel Disease

Coronado Biosciences announces initiation of phase 2 study evaluating TSO in ulcerative colitis (Coronado Biosciences Press Release) - P2, N=120; "Coronado Biosciences...announced today the initiation of a National Institutes of Health (NIH)-sponsored phase 2 study evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC)." Anticipated top-line results from Coronado’s TRUST-I trial in the U.S. and second interim analysis of TRUST-II trial in Europe in Q4 of 2013.

Anticipated P2 data • New P2 trial • Inflammatory Bowel Disease

Coronado Biosciences reports financial results for the fourth quarter and year ended December 31, 2013 (Coronado Biosciences Press Release) - TSO developmenal plan is under evaluaion as TRUST 1 study did not meet its endpoints; "Research and development expenses were $25.7 million for the year ended December 31, 2013...the increase in research and development expenses was due to expenses related to the TSO clinical program..."

Commercial • Pipeline update • Inflammatory Bowel Disease

Coronado Biosciences signs collaboration agreement with Dr. Falk Pharma and OvaMed for the development of TSO for Crohn’s disease (Coronado Biosciences) - Coronado Biosciences announced that the company signed a collaboration agreement with Dr. Falk Pharma GmbH & OvaMed GmbH for the development of TSO (Trichuris suis ova or CNDO-201) for Crohn’s disease; An independent data safety monitoring committee will conduct an interim analysis of clinical data early in Q2 2012 & will communicate their findings to Falk in the form of a blinded recommendation regarding the study; Coronado expects to commence its P2 clinical trial in Crohn’s disease in Q2 2012

Anticipated interim trial analysis • Anticipated P2 trial initiation • Collaboration agreement • Inflammatory Bowel Disease

Prerequisites for the pharmaceutical industry to develop and commercialize helminths and helminth-derived product therapy (Int J Parasitol) - Pubmed ID: 23291462; "Some clinical trials utilizing Trichuris suis or Necator americanus for the treatment of allergic disorders and inflammatory bowel disease have been conducted...In this review article, the hurdles that must be overcome before the pharmaceutical industry might invest in these novel therapies are outlined."

Review • Inflammatory Bowel Disease

Where are we on worms? (Curr Opin Gastroenterol) - "Trials using helminths like hookworm (Necator americanus) or porcine whipworm (Trichuris suis) show that they are safe and may be effective therapies for the control of the aberrant intestinal inflammation seen in Crohn's disease and ulcerative colitis"

Review • Inflammatory Bowel Disease

Coronado Biosciences reports financial results for the fourth quarter and year ended December 31, 2011 (Coronado Biosciences) - Coronado reported a net loss of $6.7M, or $0.52 per share, for Q4 2011 compared to a net loss of $1.6M, or $0.34 per share, for Q4 2010; Coronado Biosciences initiate P2b clinical trial of TSO in CD in the second quarter of this year, in addition to looking forward to the progress of the P2 trial being conducted in Europe by its development partner

Anticipated P2b initiation • Financial update • Inflammatory Bowel Disease

A Therapeutic Misadventure With Helminth Therapy for IBD (ACG 2019) - "Trichuris suis ova (TSO), porcine whipworm, has been evaluated as a possible therapy for IBD, but the most recent meta-analysis of efficacy and safety of this treatment showed no clinically significant benefit in inducing remission...Failing to improve, the patient was eventually started on infliximab infusions and obtained clinical remission...Patient was treated with mebendazole 100 mg and clinical remission was restored...Through an internet search, we identified several vendors marketing helminths for the treatment of IBD and other illnesses. The availability of these products needs to be recognized when treating patients with IBD, and the presence of parasites needs to be tested when diagnosing and treating such patients, even those from regions of the world where these infections are uncommon."

PROCTO: Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: ParaTech A/S; Trial completion date: Feb 2020 ➔ Dec 2021

Trial completion date

Preventive Trichuris suis ova (TSO) treatment protects immunocompetent rabbits from DSS colitis but may be detrimental under conditions of immunosuppression. (PubMed, Sci Rep) - "In contrast, the same TSO treatment exacerbates colitis in immunosuppressed animals. Our data provide further evidence for a therapeutic effect of TSO in IBD, yet caution is required with regard to TSO treatment in immunosuppressed patients."

Journal