OPS-2071 / Otsuka - LARVOL DELTA

Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type (clinicaltrials.gov) - P2 | N=87 | Completed | Sponsor: Otsuka Beijing Research Institute | Recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder

Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Otsuka Beijing Research Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Otsuka Beijing Research Institute

New P2 trial • Gastrointestinal Disorder

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects. (PubMed, Biomedicines) - "Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons...The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI."

Journal • Review • Developmental Disorders • Infectious Disease

In vitro antibacterial activity of OPS-2071 against Gram-positive and Gram-negative enteropathogenic bacteria. (PubMed, J Antimicrob Chemother) - "The broad and potent in vitro antibacterial activity and lower risk of drug resistance suggested that OPS-2071 may be useful for enteric infections caused by major pathogens including quinolone-resistant Campylobacter."

Journal • Preclinical • Infectious Disease

Correction for Oka et al., "In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, against Clostridioides difficile". (PubMed, Antimicrob Agents Chemother) - No abstract available

Journal • Preclinical

Antibacterial and Immunosuppressive Effects of OPS-2071, a Candidate Therapy for Inflammatory Bowel Disease. (PubMed, Dig Dis Sci) - "Our results suggest that OPS-2071 had both immunosuppressive and antibacterial effects. This dual effect makes OPS-2071 a unique and promising candidate for IBD."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CD4 • IL12A • TNFA

Novel Gut Microbiota Modulator, Which Markedly Increases Akkermansia muciniphila Occupancy, Ameliorates Experimental Colitis in Rats. (PubMed, Dig Dis Sci) - "OPS-2071 is expected to be a new therapeutic option for IBD as a gut microbiota modulator by significantly increasing A. muciniphila occupancy."

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

[VIRTUAL] In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, Against Clostridioides difficile (WMF 2021) - "OPS-2071 has the potential to become a new therapeutic option for treating C. difficile infection."

Preclinical • Infectious Disease

[VIRTUAL] In Vitro And In Vivo Antibacterial Activities Of A Novel Quinolone Compound, Ops-2071, Against Clostridioides Difficile (WMF 2021) - "There is no abstract associated with this presentation."

Preclinical

"OPS-2071 from Otsuka Pharmaceutical shows potent in vitro and in vivo activity against Clostridioides difficile #WorldMicrobeForum" (@Cortellis)

Preclinical

In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, Against Clostridioides difficile. (PubMed, Antimicrob Agents Chemother) - "Furthermore, OPS-2071 showed significant in vivo efficacy at 0.0313 mg/kg/day (50% effective doses), 39.0-fold and 52.1-fold lower than those of vancomycin and fidaxomicin, respectively, in a hamster model of C. difficile infection. OPS-2071 has the potential to become a new therapeutic option for treating C. difficile infection."

Journal • Preclinical

Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation (clinicaltrials.gov) - P2; N=3; Terminated; Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; N=240 ➔ 3; Trial completion date: Feb 2021 ➔ Apr 2020; Recruiting ➔ Terminated; Trial primary completion date: Jan 2021 ➔ Apr 2020; Sponsor Decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

OPS-2071 HEALS T CELL MEDIATED COLITIS, MURINE CROHN’S DISEASE MODEL, WITH ANTI-INFLAMMATORY AND ANTI-BACTERIAL ACTIVITY (DDW 2020) - "Two weeks following T cell transfer, OPS-2071, sulfasalazine, anti-IL12/23 p40 antibody were administered for 3 weeks, followed by assessment of efficacy evaluation by histological score and inflammatory index...At high OPS-2071 concentrations, these effects were comparable to prednisolone. The Minimum Inhibitory Concentration against IBD-related bacteria for: OPS-2071, ciprofloxacin, and metronidazole were 0.015 - 0.5, 0.25 - 8, and 0.03 - >128 mg/mL, respectively... OPS-2071 demonstrated significant therapeutic effect on colonic inflammation in the murine T cell-mediated colitis model, suppressed immune response in vitro, and showed in vitro activity against bacteria related to CD. From these in vitro results, it can be concluded that OPS-2071 has anti-inflammatory activity, independent of its antibacterial activity. The dual effects demonstrated by this novel agent, OPS-2071, provided a rationale for exploring the impact of this compound on human CD in clinical trials"

Preclinical • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD44 • IL12A