FXR314 / Organovo, Eli Lilly - LARVOL DELTA

Organovo Announces Close of the Sale of FXR Program to Eli Lilly and Company (GlobeNewswire) - "Organovo Holdings, Inc...today announced the successful close of the sale of its FXR program, including lead asset FXR314, to Eli Lilly and Company...The transaction was completed on March 25, 2025."

Commercial • Immunology • Inflammatory Bowel Disease

Organovo’s FXR Program, including FXR314, to Be Acquired by Eli Lilly and Company (GlobeNewswire) - "Organovo Holdings...announced that Eli Lilly and Company...('Lilly') will acquire Organovo’s FXR program, including its lead asset, FXR314....Under this transaction, Organovo will receive an upfront payment as well as milestones to be paid as FXR314 achieves key regulatory and commercial milestones. Lilly is acquiring all commercial and intellectual property rights to Organovo’s FXR program for worldwide development."

M&A • Inflammatory Bowel Disease

Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting (GlobeNewswire) - P2a | N=215 | NCT04773964 | Sponsor: Metacrine, Inc. | "Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean percent reduction at end of treatment of 22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and 32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo...Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo. Drug-related treatment discontinuation was low in frequency and similar across groups."

P2a data • Metabolic Dysfunction-Associated Steatohepatitis

Organovo Highlights FXR314 Near Term Value Catalysts at Jones Trading Conference Strong Preclinical and Human Rationale for FXR314 in P2 2 Ulcerative Colitis (GlobeNewswire) - "Organovo Holdings, Inc...announced that Executive Chairman Keith Murphy presented on the company’s near and long-term outlook, operational plans, at the Jones Trading Healthcare Conference in Encinitas, CA....'Completing the trial swiftly is important for our investors and for patients, as we expect to demonstrate activity of FXR314 that matches the strong results we’ve seen in a highly predictive preclinical animal model, as well as the strong data demonstrating the impact of FXR314 to relieve disease aspects in our 3d human models of ulcerative colitis and Crohn’s disease.'"

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Organovo Data Presented at Digestive Disease Week (DDW2024) Demonstrating Potential for FXR314 as Combination Therapy with Tofacitinib for Inflammatory Bowel Disease (GlobeNewswire) - "Organovo Holdings, Inc...announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company’s lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical models. DDW2024 is being held in Washington, D.C. May 18-21, 2024."

Preclinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Evaluate MET642 in Patients With NASH (clinicaltrials.gov) - P2 | N=215 | Completed | Sponsor: Metacrine, Inc. | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn’s and Colitis Congress (GlobeNewswire) - "Organovo Holdings, Inc...today announced the presentation of preclinical data related to the company’s FXR314 development program in its proprietary 3D human tissue models of Crohn’s disease and ulcerative colitis at the Crohn’s and Colitis Congress being held January 25-27, 2024 in Las Vegas, Nevada...The presentation highlights preclinical data characterizing the activity of FXR314 in 3D models of human Crohn’s disease and ulcerative colitis. FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn’s disease donors. In ulcerative colitis, FXR314 improved epithelial barrier function and fibrotic activity in all donors."

Preclinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn’s and Colitis Congress (GlobeNewswire) - "Organovo Holdings, Inc...announced that its data on the activity of FXR314 in its proprietary 3D human tissue models of Crohn’s disease and ulcerative colitis will be presented at the Crohn’s and Colitis Congress to be held January 25-27, 2024 in Las Vegas, Nevada....Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025."

New P2 trial • Preclinical • Trial completion date • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Organovo Highlights FXR314 Combination Therapy Potential and Plan (GlobeNewswire) - "Organovo Holdings, Inc...announced its intention to study combination therapy in inflammatory bowel disease and release data in calendar Q3 2024. The Company believes that the data it can generate can be powerful in establishing a strong use case for FXR314 in patients, and provide support for collaborations with major pharmaceutical companies currently offering IBD treatments....Organovo has previously announced plans for a Phase 2a study of FXR314 in ulcerative colitis, with a readout expected in 1H 2025."

P2a data • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Organovo Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 Data (GlobeNewswire) - "Organovo Holdings, Inc...announced more details about its clinical program for FXR314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis....'We are excited to be charting a path to clinical success in ulcerative colitis...'"

Clinical • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Non-alcoholic Steatohepatitis • Ulcerative Colitis

Organovo Announces FXR Program (GlobeNewswire) - "Organovo Holdings, Inc...announced a clinical program for FXR 314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis....Organovo’s FXR program announcement updates its previous guidance that it would first begin Phase 1 trials in 2025."

New P1 trial • Trial completion • Inflammatory Bowel Disease • Ulcerative Colitis

Equillium to Acquire Metacrine in All-Stock Transaction (Businesswire) - "Equillium, Inc...and Metacrine Inc...announced that the two companies have entered into a definitive merger agreement pursuant to which Equillium will acquire Metacrine in an all-stock transaction. The transaction is anticipated to add $33 million in cash to Equillium’s balance sheet at closing, which is expected to extend the company’s cash runway into 2024....Through the acquisition, Equillium adds Metacrine’s farnesoid X receptor (FXR) platform, including lead molecule MET642, an orally delivered FXR agonist that is a potential first-in-class, non-immunosuppressive treatment for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease."

M&A • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Metacrine Reports First-Quarter 2022 Results (GlobeNewswire) - "R&D Expenses - Research and development expenses were $6.7 million for the three months ended March 31, 2022, as compared to $10.9 million for the prior-year period. The decrease was primarily driven by lower clinical development costs related to the advancement of our MET409 and MET642 programs."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Metacrine Reports Fourth-Quarter 2021 Results (GlobeNewswire) - "Metacrine, Inc...today reported its fourth-quarter 2021 financial results....Phase 2 clinical trial in UC remains on track-Metacrine...expects to begin the study in the second quarter of 2022....Research and development expenses were $9.2 million for the three months ended December 31, 2021, as compared to $6.8 million for the prior-year period. The increase was primarily driven by higher clinical development costs related to the advancement of the Company’s MET409 and MET642 programs."

Commercial • Trial initiation date • Inflammatory Bowel Disease • Ulcerative Colitis

Metacrine Updates IBD Clinical Development Strategy and Implements Restructuring Plan (GlobeNewswire) - "Metacrine, Inc...announced that it remains on track to begin a Phase 2 clinical trial in ulcerative colitis. Metacrine has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 2 trial evaluating MET642 in subjects with inflammatory bowel disease (IBD) and expects to begin the study in the first half of 2022. To support ongoing clinical development of MET642 in IBD, the Company is implementing a restructuring plan to significantly reduce expenses associated with its operations in order to preserve cash...Metacrine believes it has sufficient capital to fund its current operating plan through 2023."

Commercial • New P2 trial • Inflammatory Bowel Disease • Ulcerative Colitis

Metacrine Reports Third-Quarter 2021 Results (GlobeNewswire) - "Metacrine, Inc...today reported its third-quarter 2021 financial results....Research and development expenses were $14.1 million for the three months ended September 30, 2021, as compared to $6.2 million for the prior-year period. The increase was primarily driven by higher clinical development costs related to the advancement of the Company’s MET409 and MET642 programs."

Commercial • Inflammatory Bowel Disease • Ulcerative Colitis

Metacrine Reports Interim Results for MET642 Phase 2a Trial in Patients with NASH and Announces a Strategic Re-Prioritization of Its Clinical Development Programs (GlobeNewswire) - "we have made the decision to focus Metacrine’s clinical development effort and financial resources on moving MET642 into a Phase 2 trial in IBD in the first half of 2022 and to halt future development of the FXR program in NASH."

New P2 trial • Inflammatory Bowel Disease

Study to Evaluate MET642 in Patients With NASH (clinicaltrials.gov) - P2a; N=215; Active, not recruiting; Sponsor: Metacrine, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hepatology • Non-alcoholic Steatohepatitis • FGF19 • MRI

Metacrine to Host Virtual R&D Day for Analysts and Investors on September 15, 2021 (GlobeNewswire) - "Metacrine, Inc...announced it will host a virtual R&D Day for analysts and investors on Wednesday, September 15, 2021 at 12:00 p.m. ET. The event will showcase Metacrine’s programs in...inflammatory bowel disease (IBD), as well as the introduction of a new discovery program."

Clinical • Immunology • Inflammatory Bowel Disease

[VIRTUAL] MET642, an FXR agonist with a unique chemotype, demonstrates a safe, sustained profile in a14-day randomized study in healthy subjects (EASL-ILC 2021) - "MET642, a novel FXR agonist, demonstrated sustained target engagement and an encouraging safetyand tolerability profile- including a lack of adverse LDL-C effects or pruritus−in healthy subjects after 14 days of daily oral dosing."

Clinical • Addiction (Opioid and Alcohol) • Dermatology • Dyslipidemia • Hepatology • Non-alcoholic Steatohepatitis • Pruritus • FGF19

Study to Evaluate MET642 in Patients With NASH (clinicaltrials.gov) - P2a; N=180; Recruiting; Sponsor: Metacrine, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Steatohepatitis • FGF19

[VIRTUAL] COMBINATION OF FXR AGONIST MET642 WITH TOFACITINIB EXHIBITS SYNERGISTIC EFFECTS IN IMPROVING COLITIS IN ADOPTIVE T-CELL TRANSFER IBD MODEL (DDW 2021) - "FXR agonist MET642 exhibited efficacy similar to tofacitinib or anti-IL-12 in the AT model. A combination of sub-efficacious doses of MET642 and tofacitinib synergistically improved colitis. These findings support further development of MET642 as a potential oral therapy for IBD - either as monotherapy or in combination with JAK inhibition."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Transplantation • ABCB1 • IL12A

Metacrine to Present New Preclinical Data on MET642 in Inflammatory Bowel Disease at Digestive Disease Week 2021 Virtual Meeting (GlobeNewswire) - "Metacrine, Inc...announced that it will present new preclinical data demonstrating the synergistic effect of MET642, a farnesoid X receptor (FXR) agonist, when combined with tofacitinib, a JAK inhibitor, in improving inflammatory bowel disease (IBD) at Digestive Disease Week (DDW) 2021. The virtual meeting is being held from May 21-23, 2021."

Preclinical • Inflammatory Bowel Disease

MET642, FXR AGONIST WITH A UNIQUE CHEMOTYPE, DEMONSTRATES A SAFE, SUSTAINED PROFILE IN A 14-DAY RANDOMIZED STUDY IN HEALTHY SUBJECTS (NASH-TAG 2021) - "MET409 repressed daily trough plasma C4 levels and final day area-under-the-curve (↓~53-95%, Table) relative to PBO, with repression observed throughout 24 hours post-dosing. MET642, a novel FXR agonist, demonstrated sustained target engagement and an encouraging safety and tolerability profile – including a lack of adverse LDL-C effects or pruritus − in healthy subjects after 14 days of daily oral dosing."

Clinical • Addiction (Opioid and Alcohol) • Dermatology • Dyslipidemia • Hepatology • Non-alcoholic Steatohepatitis • Pruritus • FGF19

Study to Evaluate MET642 in Patients With NASH (clinicaltrials.gov) - P2a; N=180; Not yet recruiting; Sponsor: Metacrine, Inc.

Clinical • New P2a trial • Hepatology • Non-alcoholic Steatohepatitis • FGF19