PHD1/2

Garutadustat:

Treatment of Inflammatory Bowel Disease

(Gut-restricted)

Current Stage: Phase IIa

Wholly-owned and Available for Licensing

Indication

Inflammatory bowel disease (IBD) is characterized by the inflammation of the colon and small intestine, leading to ulcerative colitis, and Crohn's disease. Ulcerative colitis primarily affects the colon and the rectum, whereas Crohn's disease affects the whole gastrointestinal tract.

These diseases are characterized by chronic inflammation and wounding of the mucosa and loss of the intestinal epithelial barrier function.

About ISM5411

Two separate Phase I studies conducted in Australia and in China indicate that ISM5411 was generally safe and well tolerated in all dose groups, demonstrating a favorable PK profile in validating gut-restrictive properties.

Supported by Insilico's commercially-available generative AI platform Chemistry42, the preclinical candidate (PCC) nomination of ISM5411 took only 12 months, during which approximately 115 molecules were synthesised and screened.

Assays Completed

• Enzymatic

• Toxicology studies

• In vitro cell-based

• Developability/CMC

• In vitro ADME studies

• In vivo PK studies

• In vivo efficacy studies with single agent

• In vivo efficacy studies Combo study with Mesalamine, Anti-TNFα antibody and CsA