A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Start Date11 Nov 2020

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

CTR20201054

/ CompletedPhase 1

一项评价MK-3655在中国健康男性受试者中单剂量和多剂量给药的安全性、耐受性、药代动力学和药效学研究

[Translation] A study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-3655 in healthy Chinese male subjects after single and multiple doses

主要目的：评价中国健康受试者在接受单次和多次MK-3655皮下注射(SC)后的安全性和耐受性。次要目的：评价中国健康受试者在接受单剂量和多剂量（每周一次）MK-3655皮下注射后的血清药代动力学。第三目的：了解单次和多次MK-3655皮下注射对中国健康受试者的药效学终点的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of single and multiple subcutaneous (SC) injections of MK-3655 in healthy Chinese subjects. Secondary objective: To evaluate the serum pharmacokinetics of single and multiple (once weekly) SC injections of MK-3655 in healthy Chinese subjects. Tertiary objective: To understand the effects of single and multiple SC injections of MK-3655 on pharmacodynamic endpoints in healthy Chinese subjects.

Start Date10 Aug 2020

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

NCT03298464

/ CompletedPhase 1

A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat

The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants

Start Date11 Sep 2017

Sponsor / Collaborator

NGM Biopharmaceuticals, Inc.

100 Clinical Results associated with NGM-313

100 Translational Medicine associated with NGM-313

100 Patents (Medical) associated with NGM-313

Literatures (Medical) associated with NGM-313

01 Jan 2026·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Efficacy and safety of fibroblast growth factor 21 analogs in metabolic dysfunction–associated steatotic liver disease and metabolic dysfunction–associated steatohepatitis: A systematic review and network meta-analysis

Review

Author: Abouelmagd, Khaled ; Taha, Nouran A ; Fareed, Areeba ; Keshk, Menna ; Taha, Amira Mohamed ; Ali, Shujaat ; Khan, Misha ; Hasan, Mohammed Tarek ; Abdelkader Saed, Sara Adel ; Abdeljawad, Marwa Muhammed

Metabolic dysfunction-associated steatotic liver disease has emerged as a global public health concern. Fibroblast growth factor 21, a liver hormone, is gaining interest because of its ability to regulate metabolism and improve metabolic dysfunction-associated steatotic liver disease. In this network meta-analysis, we investigated the efficacy of these treatments in treating metabolic dysfunction-associated steatotic liver disease. A comprehensive search was conducted across electronic databases, including PubMed, Scopus, the Cochrane Library, and Web of Science, till August 2025. We used R software to analyze data using a random effects model. Heatmaps were used to visualize the included interventions' ranking. We included 9 clinical trials comprising 1277 patients. Among them, 284 received efruxifermin, 263 received pegbelfermin, 151 received pegozafermin, 65 received efimosfermin, 139 received MK-3655, and 375 received a placebo. Pegozafermin and efruxifermin were effective in improving liver fibrosis (RR, 3.89-3.93, P < .05; RR, 2.23-1.91, P < .05, respectively), whereas the other interventions did not yield statistical significance. Efimosfermin α, efruxifermin, and pegozafermin improved different metabolic parameters, including adiponectin, hemoglobin A1c, and non-high-density lipoprotein. However, no significant differences were observed in body weight and low-density lipoprotein. For liver enzymes, efimosfermin α had the greatest reduction of alanine aminotransferase and aspartate aminotransferase, whereas efruxifermin was most effective in reducing γ-glutamyl transferase levels. The odds of adverse events were higher in pegozafermin, efimosfermin, and efruxifermin groups, mainly attributed to mild to moderate gastrointestinal adverse events. In conclusion, efruxifermin and pegozafermin are promising therapeutic options with a tolerable adverse event profile; meanwhile, efimosfermin α showed promising results in improving metabolic parameters, with histologic results yet to be published. SIGNIFICANCE STATEMENT: This meta-analysis evaluates the efficacy of fibroblast growth factor 21 analogs in improving metabolic dysfunction-associated steatotic liver disease. Efruxifermin and pegozafermin were the most significant in improving liver fibrosis; moreover; significant improvements in some metabolic parameters were observed with efimosfermin α, efruxifermin, and pegozafermin.

News (Medical) associated with NGM-313

19 Dec 2024

·www.globenewswire.com

NGM Bio and KdT Ventures Enter into Worldwide License Agreement for NGM313, a Phase 2-ready FGFR1c/β-Klotho Agonist Drug Candidate

KdT has formed a new company to develop NGM313 in a rare disease indicationNGM Bio will receive up to $608 million in upfront and potential development, regulatory and sales milestone payments, as well as tiered royalties on net sales and equity in the new company SOUTH SAN FRANCISCO, Calif. and AUSTIN, Texas, Dec. 19, 2024 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) and KdT Ventures today announced the signing of a worldwide license agreement for NGM313, a Phase 2-ready FGFR1c/β-Klotho receptor complex agonistic antibody. NGM313 was discovered by NGM Bio and has been studied in more than 300 subjects, including patients with metabolic dysfunction-associated steatohepatitis, demonstrating clinical proof of concept for target engagement and a favorable tolerability profile. KdT Ventures has formed a new company (NewCo) to develop NGM313 in a rare disease, representing the first non-metabolic indication for which NGM313 will be evaluated. NewCo plans to initiate a Phase 2 proof-of-concept study in 2025. Under the terms of the agreement, NGM Bio will provide a worldwide exclusive license to NewCo for research, development and commercialization of NGM313. NGM Bio will receive equity in the NewCo, an upfront payment and potential development, regulatory and sales milestone payments of up to $608 million and tiered royalties on net sales. “As a biology-centric company, NGM has a strong heritage elucidating novel disease-driving pathways and using creative approaches to modulate them. We’re delighted to extend this legacy through our partnership with KdT and its establishment of a biotech company anchored in the planned development of this NGM-discovered FGFR1c/β-klotho agonist drug candidate for a new indication and serious unmet need,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “We look forward to collaborating with KdT, a like-minded, science-led organization, and we’re excited for NGM313’s next chapter under the stewardship of KdT’s new venture.” "Our partnership with NGM Bio to advance NGM313 into clinical development for an important and chronically underserved patient population reflects KdT’s commitment to backing transformative science that meaningfully impacts patients' lives. In addition to our conviction in this drug candidate’s strong scientific foundation and established safety and efficacy profile, we are privileged to partner with a team as accomplished as NGM. We look forward to sharing more details in the coming months on the new company we have formed to progress this promising program," said Cain McClary, M.D., Founder and Managing Partner at KdT Ventures. About NGM BioNGM Biopharmaceuticals, Inc. (NGM Bio), a wholly owned subsidiary of NGM Bio Holdings, Inc., a clinical-stage, privately held biotechnology company, is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. NGM Bio’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates, enable their rapid advancement into proof-of-concept studies and address high unmet patient need. Visit us at http://www.ngmbio.com for more information. About KdT VenturesKdT Ventures is an early-stage venture capital firm focused on investing in science-driven companies at the intersection of technology and the physical world. Based in Austin, TX, and Research Triangle, NC, KdT partners with founders across biotechnology, healthcare, sustainability, and beyond, offering deep technical and strategic support to build transformative companies. For more information visit www.kdtvc.com. Follow us @KdT_Ventures. NGM Bio Media Contact:Liz Meloneliz@melonecomm.comORmedia@ngmbio.com KdT Ventures Media Contact:kaitlyn@kdtvc.com

License out/inPhase 1

19 Dec 2024

·endpts.com

Gilead deepens its stake in Assembly Biosciences; NGM licenses out MASH drug

Plus, news about Abilita Therapeutics, Orion, Novartis, XGEN Venture, Palleon, Henlius, TigaTx, HERVolution Therapeutics and Krystal Biotech: Gilead now owns 30% of Assembly Biosciences: The drugmaker made a $20.1 million equity investment in Assembly Bio, in addition to awarding $10 million in funding. The companies began working together in late 2023. Assembly Bio expects to share data for its experimental hepatitis D treatment in the first half of next year. Its stock $ASMB jumped 16% on Thursday morning. — Jaimy Lee NGM Bio licenses out drug: KdT Ventures, an Austin, TX-based venture firm, will dole out up to $608 million in upfront payments and biobucks for NGM313, which had been studied in MASH patients. KdT, which recently raised a new fund , set up a new company to house the drug, which will be tested in a Phase 2 trial next year for an undisclosed, non-metabolic indication. NGM was taken private earlier this year and then raised a $122 million funding round in July. — Kyle LaHucik Abilita’s antibody deal: The San Diego biotech inked a licensing and research collaboration with Orion in oncology and pain for up to $785 million. — Kyle LaHucik Novartis closes two MorphoSys sites: The MorphoSys facilities are located in the US and Germany, and the closures come after the drugmaker bought the German biotech for $2.9 billion in February. The factories are expected to shutter by the end of 2025 and will “impact” 330 employees, a Novartis spokesperson told Endpoints News . R&D programs at the two sites will be integrated into Novartis, the company added. — Anna Brown Milan VC closes fund: XGEN Venture closed its life sciences fund at €180 million. Earlier this year, it said it had targeted €200 million . — Kyle LaHucik Palleon, Henlius team up: The Boston-area biotech will work with Shanghai-based Henlius Biotech on glycan editing for autoimmune diseases. Henlius gets the exclusive license to Palleon’s E-602 in China in exchange for paying up to $95.3 million. — Kyle LaHucik TigaTx bags $35.5M to develop cancer treatment: The Boston-based biotech plans to use the cash to take its lead asset, TIGA-001, into the clinic. The company was awarded up to $33.5 million by the Advanced Research Projects Agency for Health as well as a $2 million grant from the National Cancer Institute. — Ayisha Sharma Dark genome biotech raises $11.7M in Series A: HERVolution Therapeutics expects to use the funds to advance its lead candidate, IPT-001, into human studies in 2025. The preclinical immune therapy asset targets a human endogenous retrovirus and is in development for both pancreatic and prostate cancer. The fundraise was led by the Serum Institute of India. — Ayisha Sharma Pittsburgh drugmaker shares early lung cancer data: In a Phase 1/2 study, Krystal Biotech’s inhaled candidate, called KB707, produced a 27% objective response rate and a 73% disease control rate in patients with advanced non-small cell lung cancer. The company has added two cohorts to the trial evaluating the drug in combination with a PD-1 or a PD-1 plus chemotherapy. — Ayisha Sharma

License out/inImmunotherapyAcquisition

19 Dec 2024

·www.biopharmadive.com

A venture firm breathes new life into an old NGM drug

KdT Ventures is launching a new biotechnology startup based on a drug its licensing from NGM Biopharmaceuticals, the companies announced Thursday.The deal hands the Austin-based venture firms currently unnamed startup worldwide rights to an experimental drug called NGM313, which will be developed for an unspecified rare disease. NGM Bio will get a stake in the new company, an undisclosed upfront cash payment and potentially up to $608 million in future payouts should NGM313 hit certain development, regulatory and sales targets. NGM Bio could also receive sales royalties if the drug eventually gets to market.The deal represents a revival for NGM313, an antibody drug that activates a cluster of proteins involved in metabolism. NGM once developed the drug for diabetes and a liver condition now known as metabolic dysfunction-associated steatohepatitis, or MASH and, in 2019, licensed it to Merck & Co. as part of a longstanding partnership. Merck stopped testing in 2023 and returned ownership rights, however, after the drug didnt reach the pharmaceutical companys threshold for effectivenessin a Phase 2 trial.Still, in Thursdays statement, NGM Bio and KdT noted how NGM313 has been studied in more than 300 trial volunteers, demonstrating proof that it works as intended and has a favorable tolerability profile. Those characteristics have led KdT to form a startup around it and evaluate the drug in a non-metabolic disease. A Phase 2 trial is expected to start next year.Our partnership with NGM Bio to advance NGM313 into clinical development for an important and chronically underserved patient population reflects KdTs commitment to backing transformative science that meaningfully impacts patients' lives, Cain McClary, KdTs founder and managing partner, said in the statement.The deal also marks the latest turn in whats been a roller coaster ride for NGM Bio. Launched in 2007, the company raised nearly $300 million in private funding and parlayed its relationship with Merck into a pipeline of drugs for several different conditions as well as an initial public offering in 2019. But the companys fortunes changed once publicly traded,as two of its candidates failed mid-stage trials in MASH and geographic atrophy.The company laid off a third of its workforce in 2023 and a year later, agreed to be taken private againin a deal with affiliates of The Column Group. The firm led a $122 million Series A round in July to help fund a revamped research plan for NGM, which includes a pair of Phase 2 tests in the chronic liver disease primary sclerosing cholangitis and hyperemesis gravidarum, a rare condition of pregnancy.[W]ere excited for NGM313s next chapter under the stewardship of KdTs new venture, said NGM Bio CEO David Woodhouse, in the statement.Additional details on the new startup will be shared in the coming months, McClary added. '

Phase 2License out/in

100 Deals associated with NGM-313

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	Italy	-	20 Oct 2020
Insulin Resistance	Phase 1	United States	NGM Biopharmaceuticals, Inc.	11 Sep 2017
Obesity	Phase 1	Australia	NGM Biopharmaceuticals, Inc.	01 Feb 2016
Metabolic dysfunction-associated steatotic liver disease	Preclinical	United States	NGM Biopharmaceuticals, Inc.	12 Apr 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04583423 (MK-3655-001 \| 3655-001 \| EudraCT: 2019-003048-63, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	183	MK-3655 (MK-3655 50 mg)	tyiazntuqg = itjjpmsayx pcxctuccyk (nbiafxlrgy, tnqqdipywo - bugiyufatp) View more	-	29 Apr 2024
	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	183	MK-3655 (MK-3655 100 mg)	tyiazntuqg = iadkbdkthk pcxctuccyk (nbiafxlrgy, tmkbvczyca - cbdqapcoqd) View more	-	29 Apr 2024
NASH_TAG2019	Phase 1	Metabolic Dysfunction Associated Steatohepatitis adiponectin	83	NGM313	eyzpkdvqds(enfvwbjowq) = Significant increases in adiponectin were rapidly achieved and persisted beyond 28 days; a dose response was not apparent at the three highest doses mckzydobdz (hlceptuzzt ) View more	Positive	03 Jan 2019

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