Insilico Medicine to present three abstracts at the 2026 Crohn’s & Colitis Congress highlighting clinical, preclinical safety, and efficacy data for ISM5411, a novel gut-restricted PHD1/2 inhibitor fo

Presentations include first-in-human Phase 1 results in healthy volunteers, 13-week repeat-dose toxicology in two species, and disease mitigation in a chronic T cell transfer-induced colitis model

2026-01-22

(Press-News.org) Presentations include first-in-human Phase 1 results in healthy volunteers, 13-week repeat-dose toxicology in two species, and disease mitigation in a chronic T cell transfer-induced colitis model

CAMBRIDGE, Mass. and SHANGHAI — January 22, 2026 — Insilico Medicine (“Insilico”, HKEX: 03696), a clinical-stage AI-driven biotechnology company, today announced it will present three abstracts at the 2026 Crohn’s & Colitis Congress 2026 in Las Vegas, USA on January 23, 2026 featuring new data supporting the continued development of ISM5411 (also referenced as ISM012-042), an orally administered, gut-restricted small-molecule inhibitor of prolyl hydroxylase domain proteins 1/2 (PHD1/2) for inflammatory bowel disease (IBD).

ISM5411 is designed to stabilize hypoxia-inducible factor (HIF)-1α locally in the gastrointestinal tract, promoting expression of genes protective of the intestinal mucosa and supporting maintenance and repair of mucosal integrity with the goal of reducing inflammation while limiting systemic exposure.

“These data reinforce ISM5411 as a novel, AI-driven approach to inflammatory bowel disease that targets both epithelial integrity and inflammatory pathways involved in mucosal healing,” said Carol Satler, Senior V.P. of Clinical Development at Insilico Medicine. “By reinforcing gut barrier integrity while regulating inflammation, we believe this mechanism is well suited to support both induction and long-term maintenance in IBD treatment without systemic liabilities.”

Featured data at 2026 Crohn’s & Colitis Congress

1) First-in-human Phase 1 (Australia): safety, tolerability, and pharmacokinetics consistent with gut restriction

Presentation: Poster Hall Reception | Poster #: P029 | Date/Time: Friday January 23, 2026 5:00PM-6:30PM|

Insilico will present results from a randomized, double-blind, placebo-controlled Phase 1 study in healthy subjects conducted at a single site in Australia (NCT06012578), evaluating single ascending doses (50–1000 mg) and multiple ascending doses (200, 400, 800 mg once daily for 14 days).

Key findings reported in the abstract include:

76 subjects dosed; no serious adverse events (SAEs) or deaths reported at any dose

One discontinuation due to a grade 1 rectal hemorrhage, judged not related to ISM5411

Treatment-emergent adverse event (TEAE) incidence: 25.0% for ISM5411 pooled cohort vs 55.0% for placebo; all TEAEs in ISM5411 cohorts were Grade 1

Pharmacokinetics: Oral ISM5411 resulted in very low plasma exposure and >30% excreted in feces in prototypic form, supporting a gut-restricted profile.

Biomarkers: Post-dose erythropoietin (EPO) changes largely within or near normal range; no clear trend observed in systemic VEGF across cohorts; both support a gut-restricted profile with minimal expression of systemic HIF-1α stabilization biomarkers.

2) 13-week repeat-dose toxicology (rats and dogs): favorable profile and NOAEL at highest dose tested

Presentation: Poster Hall Reception | Poster #: P145 | Date/Time: Friday January 23, 2026 5:00PM-6:30PM|

A second abstract reports results from 13-week repeat-dose oral toxicology studies in Sprague-Dawley rats (0, 100, 300, 1000 mg/kg/day) and Beagle dogs (0, 25, 80, 1000 mg/kg/day), each followed by a 28-day recovery period.

Key findings reported in the abstract include:

ISM5411 was well tolerated in both species, with no test article-related adverse findings.

Findings were limited to moderate, reversible increases in erythroid parameters in dogs (≤+30.34% in RBC count, hemoglobin, hematocrit), which fully resolved after recovery and were not considered adverse based on lack of associated pathology/histopathology.

ISM5411 demonstrates approximately 100-fold higher exposure in colon tissue versus plasma across preclinical species, supporting a gut-restricted, localized pharmacology profile with minimal systemic exposure.

No observed adverse effect level (NOAEL): 1000 mg/kg/day in both species, supporting clinical advancement and informing dose selection and safety monitoring.

3) Chronic T cell transfer-induced colitis model: preventive and therapeutic mitigation, including with anti-TNF

Presentation: Poster Hall Reception | Poster #: P147 | Date/Time: Friday January 23, 2026 5:00PM-6:30PM|

A third abstract evaluates ISM012-042 (ISM5411) in a chronic T cell transfer-induced colitis mouse model, using both preventive (days 0–42 post-colitis induction) and therapeutic (days 21–42) dosing paradigms, alone and in combination with anti-TNF-α.

Key findings reported in the abstract include:

Preventive ISM012-042 (10 or 30 mpk, PO QD) or anti-TNF-α reduced disease severity across endpoints including body weight loss, disease activity index (DAI), and colon morphology, and reduced inflammatory mucosal cytokines such as IFN-γ, TNF-α, and IL-6, along with decreases in inflammatory T cell subsets in mesenteric lymph nodes.

Histology showed less crypt damage, inflammatory infiltration, and fibrosis with administration of ISM012-042 (ISM5411) with and without anti-TNF-α.

Therapeutic dosing post-induction (and combination with anti-TNF-α) reduced DAI, colon density, and mucosal cytokines including IL-6, IFN-γ, TNF-α, and IL-17A.

Abstract titles (as submitted)

ISM5411, a novel gut-restricted PHD1/2 inhibitor for inflammatory bowel disease: a randomized, double-blind, placebo-controlled, first-in-human Phase I study to evaluate safety, tolerability and PK profiles

Preclinical Toxicology Evaluation of ISM5411: 13-Week Oral Administration in Rats and Beagle Dogs

ISM012-042 (ISM5411), a PHD1/2 inhibitor, preventatively and therapeutically mitigates T cell transfer-induced colitis in mice

By integrating advanced AI and automation technologies, Insilico has significantly improved the efficiency of early-stage drug development in real-world practices, setting a benchmark for AI-driven drug discovery. Whereas traditional early-stage drug discovery typically requires 2.5 to 4 years, more than 20+ of Insilico’s internal programs initiated between 2021 and 2024 achieved PCC nomination in just 12 to 18 months on average, with only about 60–200 molecules synthesized and tested per program.

About Insilico Medicine

Insilico Medicine is a pioneering global biotechnology company dedicated to integrating artificial intelligence and automation technologies to accelerate drug discovery, drive innovation in the life sciences, and extend health longevity to people on the planet. The company was listed on the Main Board of the Hong Kong Stock Exchange on December 30, 2025, under the stock code 03696.HK.

By integrating AI and automation technologies and deep in-house drug discovery capabilities, Insilico is delivering innovative drug solutions for unmet needs, including fibrosis, oncology, immunology, pain, obesity and metabolic disorders. Additionally, Insilico extends the reach of Pharma.AI across diverse industries, including advanced materials, agriculture, nutritional products, and veterinary medicine. For more information, please visit www.insilico.com

Media Contact

Andrew Korda
InSilico Medicine
media@insilicomedicine.com
Office: 475-225-0843

Forward-Looking Statements:

This press release contains forward-looking statements relating to the likely future developments in the business of the Company and its subsidiaries, such as expected future events, business prospects or financial performance. The words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends”, “visions”, “schedule” and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company at the time of this press release in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company currently believes are appropriate under the circumstances. However, whether actual results and developments will meet the current expectations and predictions of the Company is uncertain. Actual results, performance and financial condition may differ materially from the Company’s expectations.

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The Company, its Board, the employees and the agents of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this press release; and (b) no liability for any losses in the event that any of the forward-looking statements do not materialise or turn out to be incorrect.

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