ciclosporin CR minicapsule (ST-0529) / Sublimity Therap - LARVOL DELTA

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=235; Terminated; Sponsor: Sublimity Therapeutics Holdco Limited; Trial completion date: Dec 2021 ➔ Apr 2021; Recruiting ➔ Terminated; Trial primary completion date: Dec 2021 ➔ Apr 2021; The Sublimity Board of Directors carefully evaluated the IA data: the 9.6% treatment remission difference for 75mg BID vs placebo (due to an increase in placebo response rate) was determined not sufficient to continue to fund the study

Clinical • Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] COMPARATIVE BIOAVAILABILITY OF NOVEL CYCLOSPORINE FORMULATIONS VERSUS REFERENCE ORAL CYCLOSPORINE IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS (UEGW 2020) - "Introduction: A novel formulation of cyclosporine (CyCol) was designed to deliver active drug directly to the colon, thus allowing for precise targeting of inflamed mucosal epithelium typical for ulcerative colitis (UC) while limiting systemic toxicity. All formulations were safe and well tolerated, with no major side effects and similar safety profiles, particularly with respect to the number of subjects reporting TEAEs. The results show that the delayed colon release CyCol formulations are associated with less absorption and lower systemic exposure of drug when compared to the reference."

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

[VIRTUAL] COMPARATIVE BIOAVAILABILITY OF NOVEL CYCLOSPORINE FORMULATIONS VERSUS REFERENCE ORAL CYCLOSPORINE IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS (UEGW 2020) - "Introduction: A novel formulation of cyclosporine (CyCol) was designed to deliver active drug directly to the colon, thus allowing for precise targeting of inflamed mucosal epithelium typical for ulcerative colitis (UC) while limiting systemic toxicity. All formulations were safe and well tolerated, with no major side effects and similar safety profiles, particularly with respect to the number of subjects reporting TEAEs. The results show that the delayed colon release CyCol formulations are associated with less absorption and lower systemic exposure of drug when compared to the reference."

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

[VIRTUAL] COMPARATIVE BIOAVAILABILITY OF NOVEL CYCLOSPORINE FORMULATIONS VERSUS REFERENCE ORAL CYCLOSPORINE IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS (UEGW 2020) - "Introduction: A novel formulation of cyclosporine (CyCol) was designed to deliver active drug directly to the colon, thus allowing for precise targeting of inflamed mucosal epithelium typical for ulcerative colitis (UC) while limiting systemic toxicity. All formulations were safe and well tolerated, with no major side effects and similar safety profiles, particularly with respect to the number of subjects reporting TEAEs. The results show that the delayed colon release CyCol formulations are associated with less absorption and lower systemic exposure of drug when compared to the reference."

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

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Sublimity Therapeutics Holdco Limited; Trial completion date: Nov 2020 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Dec 2021

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

PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Sigmoid Pharma; Active, not recruiting -> Completed

Trial completion • Biosimilar

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of a Targeted Release Oral Cyclosporine Formulation in the Treatment of Mild to Moderate Ulcerative Colitis: Influence of Immunosuppressants at Baseline (ACG 2019) - "Introduction: Patients (pts) with ulcerative colitis (UC) who have failed immunosuppressants (IM) and biologics have demonstrated poorer response to subsequent therapies.1 Cyclosporine (CsA) could be an alternative option since it has similar efficacy and safety to infliximab for severe UC,2 but its use is limited due to concerns regarding systemic toxicity...The poorer response in the IM treated group was potentially a function of severity or refractory disease and/or concomitant use of UC medication (prednisone < 10mg/day, 5-ASAs or purine analogues) at baseline. Table 1 shows the influence of baseline medications on the improvement of DAI scores in subjects with moderate UC, and tables 2 and 3, the impact of IM on the analyzed parameters. Safety was balanced for the overall population. This analysis showed that clinical improvement and composite subscores were influenced by baseline medication in pts with moderate UC."

Clinical

ST-0529 IN MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS: LESSONS LEARNED AND PERSPECTIVES (UEGW 2019) - "Although cyclosporine (CsA) has similar safety and efficacy to infliximab for acute severe UC management, its use is limited due to its serious systemic side effects (SSE). Orally administered ST-0529 represents a novel approach to attaining therapeutically relevant tissue concentrations of CsA in the colon and may offer an alternative for inadequate clinical response to traditional therapies. The results from this trial will help identify the appropriate dose(s) of ST-0529 for use in phase 3 clinical studies."

Targeted Release Oral Cyclosporine (ST-0529) As a Potential New Therapy for Ulcerative Colitis: Phase I Study Results (DDW 2019) - "Cyclosporine (CsA) has shown similar efficacy and safety to infliximab when administered by intravenous (IV) injection followed by oral therapy in the treatment of acute severe UC. These results suggest that ST-0529 has potential to provide similar or enhanced efficacy to IV or oral CsA formulations and may be better tolerated long-term in patients with UC. Future clinical trials are warranted to determine whether colon-specific delivery of ST-0529 can impact induction and maintenance of remission in UC."

P1 data

A randomised, multi-centre, double-blind, placebo-controlled study of a targeted release oral cyclosporine formulation in the treatment of mild-to-moderate ulcerative colitis: efficacy Results (ECCO-IBD 2019) - "Background Cyclosporine (CsA) is an effective treatment for patients with acute severe ulcerative colitis (UC), and studies have shown that it has an impact on disease activity comparable to the anti-TNF agent, infliximab.1,2 Concerns regarding systemic toxicities have limited its role to short-term induction therapy and as a bridge to other therapies. In the post hoc analysis, differences in the clinical response between treatment subgroups achieved statistical significance in some subgroups, the largest clinical response rate in moderate UC patients taking 5-aminosalicylates and/or steroids. These preliminary data, added to the data from a Phase 1 study, support further development of ST-0529 as a treatment for the induction and maintenance of remission in UC patients with moderate to severe disease."

Clinical

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis (clinicaltrialsregister.eu) - P2; N=280; Ongoing; Sponsor: Sublimity Therapeutics (Hold Co) Ltd.

Clinical • New P2 trial

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Sublimity Therapeutics Holdco Limited

Clinical • New P2 trial

TARGETED RELEASE ORAL CYCLOSPORINE FORMULATION AS A POTENTIAL NEW THERAPY FOR ULCERATIVE COLITIS (CCCongress 2019) - "Infliximab has long been a standard therapy for moderate to severe UC. The study demonstrated ST-0529 achieved similar or higher colonic tissue concentrations than continuous IV CsA infusion with substantially lower systemic exposure. These data suggest that ST-0529 may provide similar or enhanced efficacy to IV or oral CsA formulations with an improved tolerance profile and thus support further development as a treatment for the induction and maintenance of remission in UC."

Sublimity Therapeutics receives Investigational New Drug (IND) clearance from U.S. Food and Drug Administration (FDA) (GlobeNewswire) - "Sublimity Therapeutics...announced today that the company has received FDA clearance to proceed with its phase 2b clinical trial of the company’s lead drug candidate, ST-0529. The aim of this multicenter, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the safety, efficacy and tolerability of ST-0529 for patients with moderate to severe ulcerative colitis."

IND

"Thank you @brightonargus for the coverage today! https://t.co/eQmdwMli1Y @Rockinghorse67 @riseuk @sussexbeacon @GBSSupport @thectsbrighton @alzheimerssoc & Nkuringo Foundation #share7 #givingback @brightonchamber @WiredSussex @agencycollectve" (@SearchSeven)