SOR102 / Sorriso Pharma - LARVOL DELTA

Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. (PubMed, Lancet Gastroenterol Hepatol) - P1 | "The favourable safety profile and preliminary evidence for efficacy support development of SOR102 for treatment of ulcerative colitis."

First-in-human • Journal • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Gynecology • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

ORAL ADMINISTRATION OF SOR102 DELIVERS ANTI-TNF/IL-23 ACTIVITY DIRECTLY TO COLONIC TISSUE AND DRIVES CLINICAL AND PHARMACODYNAMIC RESPONSES IN ULCERATIVE COLITIS PATIENTS (UEGW 2025) - P1 | "High and sustained levels of active monomers in feces confirmed SOR102 is efficiently cleaved, and activity is maintained after oral dosing in UC patients. Levels of SOR102 monomers in sigmoid colonic tissue increased with oral dose, with minimal systemic exposure. In the BID arm, SOR102 demonstrated strong and consistent activity across multiple clinical and tissue PD endpoints in patients with UC."

Clinical • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IFNG • IL10 • IL17A • IL1B • IL23A • IL6 • TNFA

PHASE 1B STUDY OF SOR102, A NOVEL, ORALLY DELIVERED BISPECIFIC ANTI-TNF/ANTI-IL-23 DOMAIN ANTIBODY IN PATIENTS WITH MILD TO SEVERE ULCERATIVE COLITIS (DDW 2025) - P1 | "Efficacy across multiple endpoints was observed in the SOR102 BID arm compared to the QD and placebo arms, despite the relatively short duration of treatment. These results warrant further clinical development of SOR102."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis • CRP • IL23A • TNFA

Sorriso Pharmaceuticals Presents Positive SOR102 Phase 1b Ulcerative Colitis Data at ECCO Conference (EIN Presswire) - P1b | N=22 | NCT06080048 | Sponsor: Sorriso Pharmaceuticals, Inc. | "Safety and Tolerability: : SOR102 exhibited a favorable safety profile, with adverse events predominantly mild to moderate in severity; no new safety signals were observed....Efficacy: In the intent-to-treat (ITT) analysis, Mayo Score and modified Mayo Score clinical response were 56% and 67% in the high-dose SOR102 group compared to 17% and 33% in the placebo group, respectively....Sorriso is advancing SOR102 into Phase 2 trials, expected to begin later this year....'The data reflect not only robust efficacy in reducing disease activity but also demonstrate the convenience of an oral formulation, which may improve patient adherence and quality of life. These results strengthen our commitment to advancing this promising candidate into later-stage clinical trials.'"

New P2 trial • P1 data • Ulcerative Colitis

Phase 1b study of SOR102, a novel, orally delivered bispecific anti-TNF/anti-IL-23 domain antibody in patients with mild to severe ulcerative colitis (ECCO-IBD 2025) - P1 | "Efficacy across multiple endpoints was observed in the SOR102 BID arm compared to QD and placebo, despite the short treatment duration. Further clinical development of SOR102 is warranted."

Clinical • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP • IL23A • TNFA

Sorriso Pharmaceuticals Announces Positive Phase 1b Clinical Trial Results for SOR102 in Ulcerative Colitis (Businesswire) - P1b | N=22 | NCT06080048 | Sponsor: Sorriso Pharmaceuticals, Inc. | "The study met its primary objectives, demonstrating a favorable safety and tolerability profile. Additionally, key exploratory efficacy endpoints showed promising activity of SOR102 across multiple clinical endpoints. This is the first successful demonstration of an orally dosed antibody delivering clinical efficacy....Among patients who completed the study, those in the high-dose SOR102 group achieved statistically significant separation from placebo across multiple clinical endpoints, including Mayo Score clinical response, modified Mayo Score clinical response, symptomatic remission, and mean decreases from baseline in Mayo Score, modified Mayo Score, and UC-100 score. Based on these results, Sorriso Pharmaceuticals plans to initiate a Phase 2 clinical trial in 2025, further evaluating SOR102 in a larger patient population....The detailed study results will be presented at the upcoming 20th Congress of ECCO..."

New P2 trial • P1 data • Ulcerative Colitis

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Sorriso Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Nov 2024

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

FIRST IN HUMAN STUDY OF SOR102, A NOVEL, ORALLY DELIVERED BISPECIFIC ANTI-TNF/ANTI-IL-23 DOMAIN ANTIBODY IN CLINICAL DEVELOPMENT FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (UEGW 2024) - P1 | "SOR102 was well tolerated at all tested doses. Systemic exposure of SOR102 and its monomers was not observed, supporting its gut selectivity. Low levels of intact SOR102 and high levels of SOR102 monomers in faeces confirm that SOR102 is efficiently cleaved after oral dosing, as designed."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Sorriso Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

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

NOVEL ORALLY DELIVERED BISPECIFIC ANTIBODY FOR LOCAL GI ACTIVITY: SOR102, AN ANTI-TNFα/ANTI-IL-23 ANTIBODY IN CLINICAL DEVELOPMENT FOR TREATMENT OF INFLAMMATORY BOWEL DISEASE (DDW 2024) - P1 | "Collectively these data support a low risk of systemic immunosuppression after oral SOR10 dosing in IBD patients. SOR10 is the first orally delivered anti-TNF/anti-IL- 3 dual-specific therapeutic and is currently in a Phase I/Ib clinical trial to assess safety pharmacokinetics and pharmacodynamics in healthy volunteers and UC patients (NCT06080048)."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Sorriso Pharmaceuticals, Inc. | N=42 ➔ 18

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

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Sorriso Pharmaceuticals, Inc.

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

Sorriso Pharmaceuticals Announces First Subject Dosed in Phase 1/1b Clinical Trial of SOR102 (EIN News) - "Sorriso Pharmaceuticals...today announced that the first subject has been dosed in the company’s Phase 1/1b clinical program of SOR102. SOR102 is a dual-acting oral biologic treatment targeting TNF⍺ and IL-23(p19) that is being developed for the treatment of inflammatory bowel disease (IBD)....This Phase 1 trial is a randomized, double-blind study consisting of three parts. Parts 1 and 2 will evaluate safety, tolerability and pharmacokinetics (PK) of single ascending oral doses and multiple oral doses in healthy participants. Part 3 will evaluate safety, tolerability, PK, and clinical and biological activity of multiple oral doses of SOR102 in patients with mild to severe ulcerative colitis. The trial is expected to enroll up to 60 adult participants at sites in the United Kingdom and Europe."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Sorriso Pharmaceuticals, Inc.

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Sorriso Pharmaceuticals Launches with $31 Million to Develop Novel Class of Orally Delivered Cytokine Antibodies to Treat Inflammatory Conditions (PRNewswire) - "Series A Financing Funds Multiple Programs to Phase 1 and IND stage...Sorriso Pharmaceuticals...announced the company has closed on a $31 million Series A financing. The round was co-led by New Enterprise Associates (NEA), and Arix Bioscience plc. The new funding will be used to advance its pipeline of novel oral antibodies to address unmet needs in immune- mediated diseases. Sorriso Pharmaceuticals is a biotechnology company advancing a pipeline of disease-modifying antibodies for the treatment of inflammatory disease, including Crohn's disease and ulcerative colitis."

Financing • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis