SGM-1019 / Evotec - LARVOL DELTA

Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Second Genome

New P2 trial • Biosimilar • Gastroenterology • Hepatology • Immunology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2; N=9; Terminated; Sponsor: Second Genome; N=100 ➔ 9; Trial completion date: Dec 2019 ➔ May 2019; Recruiting ➔ Terminated; Trial primary completion date: Nov 2019 ➔ May 2019; Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

"some #ILC2019 #EASL19 abstracts * Second Genome SGM-1019 --> $EVT * $IVA lanifibranor PC eval vs other agents w/ activity on PPARs * $GNFT elafibranor combos" (@BiotechRadar)

Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Second Genome; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Second Genome doses first patient in trial for NASH inflammation therapy (Healio) - P2a, N=100; '"There are no approved therapies for NASH at this time, and, while there are many in development, SGM-1019 is directed at the inflammation underlying this condition,' Stephen A. Harrison...said in the release. 'We know that inhibiting P2X7 results in significant reduction in inflammation and fibrosis in preclinical models of disease and look forward to seeing the data from this study. SGM-1019 has the potential to provide a much-needed treatment option for the growing number of patients with NASH.'"

Media quote • P2a data

"* Pledpharma $PLED: PledOx/Aladote ph 1/2 Oral presentation * Second Genome/Evotec $EVT: SGM-1019 poster * AltImmune/Valneva $VLA (IC31): HepTcell ph 1 in HBV poster * Inventiva $IVA at least 1 abstract (couldn't find title)" (@BiotechRadar)

Second Genome doses first patient in phase 2 clinical study of SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH) (PRNewswire) - P=2a, N=100; NCT03676231; Sponsor: Second Genome, Inc.; "Second Genome, Inc....today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH)....'There are no approved therapies for NASH at this time, and, while there are many in development, SGM-1019 is directed at the inflammation underlying this condition,' said Stephen Harrison...The Phase 2a randomized, double-blind, placebo-controlled study of SGM-1019 will enroll 100 patients with NASH at leading treatment centers across the United States....Top line data are expected in the first half of 2020."

Enrollment status • Media quote • P2a data

Evotec receives milestone payment for start of phase II clinical trial (Evotec Press Release) - "Evotec AG...announced today that it has earned a $ 2 m milestone payment from Second Genome, Inc....for the initiation of a Phase II clinical study of SGM 1019...for the treatment of nonalcoholic steatohepatitis (NASH)....The agreement between Evotec and Second Genome triggered an undisclosed upfront payment and Evotec is eligible for clinical and regulatory milestones as well as royalty payments related to commercialisation."

Financing • Licensing / partnership