A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

Start Date24 Oct 2023

Sponsor / Collaborator

Sorriso Pharmaceuticals, Inc.

100 Clinical Results associated with Sorriso Pharmaceuticals, Inc.

0 Patents (Medical) associated with Sorriso Pharmaceuticals, Inc.

Literatures (Medical) associated with Sorriso Pharmaceuticals, Inc.

Scientific ReportsQ3 · CROSS-FIELD

Preclinical development of a bispecific TNFα/IL-23 neutralising domain antibody as a novel oral treatment for inflammatory bowel disease

Q3 · CROSS-FIELD

ArticleOA

Author: Rodrigues-Duarte, Lurdes ; Cubitt, Marion F ; Carlton, Timothy M ; West, Michael R ; Maggiore, Luana ; Clare, Simon ; Harcourt, Katherine ; Roberts, Kevin J ; Vossenkämper, Anna ; MacDonald, Thomas T ; Ray, Keith P ; Chai, Ray ; Crowe, J Scott

AbstractAnti-TNFα and anti-IL-23 antibodies are highly effective therapies for Crohn’s disease or ulcerative colitis in a proportion of patients. V56B2 is a novel bispecific domain antibody in which a llama-derived IL-23p19-specific domain antibody, humanised and engineered for intestinal protease resistance, V900, was combined with a previously-described TNFα-specific domain antibody, V565. V56B2 contains a central protease-labile linker to create a single molecule for oral administration. Incubation of V56B2 with trypsin or human faecal supernatant resulted in a complete separation of the V565 and V900 monomers without loss of neutralising potency. Following oral administration of V900 and V565 in mice, high levels of each domain antibody were detected in the faeces, demonstrating stability in the intestinal milieu. In ex vivo cultures of colonic biopsies from IBD patients, treatment with V565 or V900 inhibited tissue phosphoprotein levels and with a combination of the two, inhibition was even greater. These results support further development of V56B2 as an oral therapy for IBD with improved safety and efficacy in a greater proportion of patients as well as greater convenience for patients compared with traditional monoclonal antibody therapies.

Hepatology Communications

Safety, tolerability, and efficacy of maralixibat in adults with primary sclerosing cholangitis: Open-label pilot study

Article

Author: Bowlus, Christopher L. ; Levy, Cynthia ; Cheung, Angela C. ; McKibben, Andrew ; Hirschfield, Gideon M. ; Vig, Pamela ; Dorenbaum, Alejandro ; Moylan, Cynthia A. ; Pockros, Paul J. ; Baek, Marshall ; Kennedy, Ciara ; Forman, Lisa M. ; Thorburn, Douglas ; Eksteen, Bertus ; Chien, Elaine ; Jaecklin, Thomas

Background:Primary sclerosing cholangitis (PSC) is frequently associated with pruritus, which significantly impairs quality of life. Maralixibat is a selective ileal bile acid transporter (IBAT) inhibitor that lowers circulating bile acid (BA) levels and reduces pruritus in cholestatic liver diseases. This is the first proof-of-concept study of IBAT inhibition in PSC.Methods:This open-label study evaluated the safety and tolerability of maralixibat ≤10 mg/d for 14 weeks in adults with PSC. Measures of pruritus, biomarkers of BA synthesis, cholestasis, and liver function were also assessed.Results:Of 27 enrolled participants, 85.2% completed treatment. Gastrointestinal treatment-emergent adverse events (TEAEs) occurred in 81.5%, with diarrhea in 51.9%. TEAEs were mostly mild or moderate (63.0%); 1 serious TEAE (cholangitis) was considered treatment related. Mean serum BA (sBA) levels decreased by 16.7% (−14.84 µmol/L; 95% CI, −27.25 to −2.43; p = 0.0043) by week 14/early termination (ET). In participants with baseline sBA levels above normal (n = 18), mean sBA decreased by 40.0% (−22.3 µmol/L, 95% CI, −40.38 to −4.3; p = 0.004) by week 14/ET. Liver enzyme elevations were not significant; however, increases of unknown clinical significance in conjugated bilirubin levels were observed. ItchRO weekly sum scores decreased from baseline to week 14/ET by 8.4% (p = 0.0495), by 12.6% (p = 0.0275) in 18 participants with pruritus at baseline, and by 70% (p = 0.0078) in 8 participants with ItchRO daily average score ≥3 at baseline.Conclusions:Maralixibat was associated with reduced sBA levels in adults with PSC. In participants with more severe baseline pruritus, pruritus improved significantly from baseline. TEAEs were mostly gastrointestinal related. These results support further investigation of IBAT inhibitors for adults with PSC-associated pruritus. ClinicalTrials.gov: NCT02061540.

News (Medical) associated with Sorriso Pharmaceuticals, Inc.

18 Sep 2024

·www.globenewswire.com

SoCalBio’s 26th Annual Two-Day Investor Partnership Conference hosted at the Hyatt Regency Newport Beach for the Medical Device and Biotechnology Industry

Annual Conference in Orange County Will Showcase Latest Bioscience Advancements in AI, Diagnostics, Therapeutics, Digital Health, Implantable and Wearable Medical DevicesLOS ANGELES, Sept. 18, 2024 (GLOBE NEWSWIRE) -- SoCalBio (the Southern California Biomedical Council) today announced the full lineup of speakers and presenting companies for its 26th Annual SoCalBio Investor & Partnership Conference, which will be held September 25-26 at the Hyatt Regency Newport Beach. Since 1995, SoCalBio has served as the voice and advocate for the bioscience, medical devices, and digital health industries across the Greater Los Angeles region. Now in its 26th year, the Annual Investor & Partnership Conference is the region’s premier local showcase for innovation in a range of market segments, from medical devices, diagnostics, therapeutics, and regenerative medicine to drug delivery, healthcare informatics, and AI. For the first time, SoCalBio is bringing the conference to Orange County – a part of greater Los Angeles with significant bioscience industry growth. Orange County is home to world-class R&D, investors, and more than 65,000 industry professionals employed at 2,000-plus companies. The conference will start with an economic report from Ryan Helwig of TEConomy highlighting trends to watch within the life science industry including investments, employment data, and NIH regional funding totals versus national data. Also, plenary sessions ranging from a workforce development panel focusing on “Demystifying Apprenticeships” to sessions examining the latest innovations for “Medical Devices of Tomorrow” and “The Future of Targeted Therapy.” Other conference highlights include a session by SoCalBio’s W3 (Women, Work & Wisdom) group focused on go-to-market strategies for disruptive products. This year’s conference will also introduce investors and potential partners to 30 carefully selected emerging and mid-stage companies with the potential to deliver breakthrough innovations (see list below). Los Angeles-based VCs OCV and Westlake Village Bio Partners will be part of the at least 20 VCs in attendance (see agenda). “SoCalBio’s annual conference showcases life science innovation (MedTech & BioTech) from across Southern California and Canada and explores pathways to bring that innovation to market,” said SoCalBio President & CEO Walid Sabbagh, Jr., PhD. “It is a signature event designed for industry professionals, investors, researchers, educators, policymakers, and service providers to support our local companies and also foster the next generation of emerging companies in Greater Los Angeles.” List of Presenting Companies: Airware (blood sugar monitoring via handheld sensors)Amberstone Biosciences (Tumor Microenvironment Acidity-activated Therapeutic (T-MATE) T-cell engagers)Aureka Biotechnologies (therapy discovery platform integrating high-throughput digital biology and generative AI)AutoMedicus Corporation (medical devices to decrease morbidity and mortality by controlling blood pressure during surgery and in the ICU)Chimera Therapeutics (cell-based allogeneic therapy for sickle cell disease)Cobionix (smart robotic labor solutions to scale healthcare delivery)EarlyDx (non-invasive liquid biopsy tests for early cancer detection and precision medicine)Elle, MD Biotechnologies Inc. (non-hormonal contraceptive devices)Finally Quiet (noise-canceling wireless communication system for dental clinics)Lidavex (LiDAR-based devices for monitoring cervical dilation and effacement)Materia Bioworks (insights and expertise to launch sustainable products using biomaterials)MAX BioPharma (oxysterol-based drug candidates with unique biological and therapeutic properties)Nura Health (diagnostic blood test for endometriosis that shortens the path to diagnosis)Orpyx (Orpyx SI® Sensory Insole platform for the prevention of diabetic foot ulcers and amputations)PlantForm (proprietary plant-based expression system to develop antibody and protein-based therapeutics)Proteas Health (technology to identify people at risk of a heart attack before symptoms appear)Rubato Life (AI-powered, biometrically personalized music therapy for seniors suffering from dementia and cognitive impairment)Shift Pharmaceuticals (targeted mRNA therapeutics for rare and debilitating genetic disorders)SLAM BioTherapeutics (antibodies and antibody-drug conjugates (ADCs) against the signaling lymphocytic activation molecule (SLAM) protein family)Sorriso Pharmaceuticals (disease-modifying antibodies for the treatment of immune-mediated diseases, including Crohn’s disease and ulcerative colitis)Sundaze (heated therapy garments to relieve period pain) The full conference agenda and information about presenting companies, speakers, and attendee registration is available at https://socalbio.org/events/socalbio-26th-annual-conference/. SoCalBio acknowledges the support of conference sponsors including Avantor, Canada, Perkins Coie, and CBIZ. About SoCalBio:SoCalBio is a nonprofit, member-supported trade association that promotes bioscience research, development, manufacturing, job creation, and overall economic growth in the Greater Los Angeles region. The Council’s programs help local firms access capital, potential partners, and business support services. The annual SoCalBio Conference has grown to become the region’s premier showcase for emerging life-science companies and technologies. SoCalBio also promotes technology transfer and workforce training while informing policymakers and the public at large about the benefits of the region’s life-science industry. More information about SoCalBio is available at www.socalbio.org. Contact:ExcelPR Group (for SoCalBio) Erik Deutsch, 323-851-2300 x112erikd[at]excelpr[dot]com

100 Deals associated with Sorriso Pharmaceuticals, Inc.

100 Translational Medicine associated with Sorriso Pharmaceuticals, Inc.

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Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

SOR-101 ( TNF-α )	Colitis More	Phase 2
SOR-102 ( IL-23 x TNF-α )	Colitis, Ulcerative More	Phase 1
SOR-104 ( IL-7Rα )	-	Preclinical
US11667719 ( IL-7Rα )	Inflammatory Bowel Diseases More	Discovery

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