A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

Start Date29 Jul 2019

Sponsor / Collaborator

Gilead Sciences, Inc.

[+1]

ACTRN12619000655145 / CompletedPhase 1

A Phase 1 Open-Label, Parallel-Group, Two-Treatment, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9674 and GS-0976 in Subjects with Normal Renal Function and Severe Renal Impairment

Start Date24 Jul 2019

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT03449446 / CompletedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

The primary objectives of this study are:
To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH
To evaluate changes in liver fibrosis, without worsening of NASH

Start Date21 Mar 2018

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Firsocostat

100 Translational Medicine associated with Firsocostat

100 Patents (Medical) associated with Firsocostat

Literatures (Medical) associated with Firsocostat

10 Jan 2024·Antimicrobial agents and chemotherapy

Repurposing a human acetyl-CoA carboxylase inhibitor firsocostat to treat fungal candidiasis alone and in combination

Article

Author: Zeng, Liping ; Xu, Jingchen ; Feng, Ganzhu ; Luo, Peipei ; Yao, Jing ; Hang, Xudong ; Liu, Genyan ; Chen, Tianyu ; Quan, Keao ; Bi, Hongkai ; Tong, Qian

ABSTRACT:

Opportunistic fungal infections, particularly caused by Candida albicans , remain a common cause of high morbidity and mortality in immunocompromised patients. The escalating prevalence of antifungal drug resistance necessitates the immediate exploration of alternative treatment strategies to combat these life-threatening fungal diseases. In this study, we investigated the antifungal efficacy of firsocostat, a human acetyl-CoA carboxylase (ACC) inhibitor, against C. albicans . Firsocostat alone displayed moderate antifungal activity, while combining it with voriconazole, itraconazole, or amphotericin B exhibited synergistic effects across almost all drug-sensitive and drug-resistant C. albicans strains tested. These observed synergies were further validated in two mouse models of oropharyngeal and systemic candidiasis, where the combination therapies demonstrated superior fungicidal effects compared to monotherapy. Moreover, firsocostat was shown to directly bind to C. albicans ACC and inhibit its enzymatic activity. Sequencing spontaneous firsocostat-resistant mutants revealed mutations mapping to C. albicans ACC, confirming that firsocostat has retained its target in C. albicans . Overall, our findings suggest that repurposing firsocostat, either alone or in combination with other antifungal agents, holds promising potential in the development of antifungal drugs and the treatment of candidiasis.

01 May 2023·Journal of clinical pharmacology

Effect of Renal Impairment on the Pharmacokinetics of Firsocostat, an Acetyl‐Coenzyme A Carboxylase Inhibitor, and Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist

Article

Author: Weber, Elijah ; Nelson, Cara ; Ding, Dora ; Qin, Ann ; Xiao, Deqing ; Watkins, Timothy R. ; Younis, Islam R. ; Othman, Ahmed A.

Abstract:

Firsocostat, a liver‐targeted acetyl‐coenzyme A carboxylase inhibitor, and cilofexor, a nonsteroidal farnesoid X receptor agonist, are being developed in combination for treatment of nonalcoholic steatohepatitis. This phase 1 study evaluated firsocostat and cilofexor pharmacokinetics and tolerability in participants with severe renal impairment (SRI) and healthy matched controls (HMCs). Ten participants with SRI (estimated glomerular filtration rate by Modification of Diet in Renal Disease <30 mL/min/1.73 m2), and 10 HMCs received single oral doses of firsocostat (20 mg) on day 1 and cilofexor (100 mg) on day 7 in a fasted state. Plasma concentrations of firsocostat (and nonactive metabolite GS‐834773) and cilofexor (and nonactive metabolites GS‐716070 and GS‐1056756) were collected over 96 hours and quantified; plasma exposures (area under the concentration‐time curve [AUC] and peak concentration [Cmax]) and plasma protein binding were characterized. Firsocostat AUC was ≈40% higher in SRI versus HMC, while Cmax was 8% lower. Observed exposures of the firsocostat metabolite were ≈4.6‐fold higher in SRI participants versus HMC. Exposures (AUC and Cmax) of cilofexor and metabolites and percentages of protein binding of all analytes were similar between SRI and HMC groups. Treatment‐emergent adverse events were generally mild and not considered related to study drug. A <50% increase in firsocostat exposure was observed among SRI participants but was deemed not clinically relevant. There was no apparent effect of SRI on cilofexor exposure. Based on this trial, firsocostat and cilofexor dosing are not expected to require modification in patients who are renally impaired.

01 Mar 2023·Journal of lipid research

Acetyl-CoA carboxylase inhibitor increases LDL-apoB production rate in NASH with cirrhosis: prevention by fenofibrate

Article

Author: Kim, Rachael ; Huss, Ryan S ; Mohammed, Hussein ; Mann, Sabrina ; Myers, Robert P ; Han, Julia ; Hellerstein, Marc ; Billin, Andrew N ; Zhu, Kaiyi ; Chung, Chuhan ; Li, Kelvin ; Chuang, Jen-Chieh ; Dandan, Mohamad

Treatment with acetyl-CoA carboxylase inhibitors (ACCi) in nonalcoholic steatohepatitis (NASH) may increase plasma triglycerides (TGs), with variable changes in apoB concentrations. ACC is rate limiting in de novo lipogenesis and regulates fatty acid oxidation, making it an attractive therapeutic target in NASH. Our objectives were to determine the effects of the ACCi, firsocostat, on production rates of plasma LDL-apoB in NASH and the effects of combined therapy with fenofibrate. Metabolic labeling with heavy water and tandem mass spectrometric analysis of LDL-apoB enrichments was performed in 16 NASH patients treated with firsocostat for 12 weeks and in 29 NASH subjects treated with firsocostat and fenofibrate for 12 weeks. In NASH on firsocostat, plasma TG increased significantly by 17% from baseline to week 12 (P = 0.0056). Significant increases were also observed in LDL-apoB fractional replacement rate (baseline to week 12: 31 ± 20.2 to 46 ± 22.6%/day, P = 0.03) and absolute synthesis rate (ASR) (30.4-45.2 mg/dl/day, P = 0.016) but not plasma apoB concentrations. The effect of firsocostat on LDL-apoB ASR was restricted to patients with cirrhosis (21.0 ± 9.6 at baseline and 44.2 ± 17 mg/dl/day at week 12, P = 0.002, N = 8); noncirrhotic patients did not change (39.8 ± 20.8 and 46.3 ± 14.8 mg/dl/day, respectively, P = 0.51, N = 8). Combination treatment with fenofibrate and firsocostat prevented increases in plasma TG, LDL-apoB fractional replacement rate, and ASR. In summary, in NASH with cirrhosis, ACCi treatment increases LDL-apoB100 production rate and this effect can be prevented by concurrent fenofibrate therapy.

News (Medical) associated with Firsocostat

12 Feb 2024

·medcitynews.com

Gilead’s $4.3B CymaBay Acquisition Adds Liver Disease Drug Under FDA Review

Gilead Sciences is acquiring biotech company CymaBay Therapeutics in a $4.3 billion deal that comes with a drug candidate currently under FDA review in a rare liver disease with few treatments. According to deal terms announced Monday, Gilead will pay $32.50 cash for each share of CymaBay. That price is a 27% premium to CymaBay’s closing stock price on Friday. The acquisition marks a comeback for the company and its drug, which just a few years ago faced an uncertain future amid safety questions. The main asset of CymaBay is seladelpar, a drug that the Newark, California-based company has developed for treating primary biliary cholangitis (PBC), a rare and progressive autoimmune condition that destroys the bile ducts of the liver. But this small molecule was at one time among the leading drug candidates for nonalcoholic steatohepatitis (NASH), a fatty liver disease that has no FDA-approved treatments. In 2019, a safety signal led CymaBay to stop a mid-stage test of seladelpar in NASH as well as a recently started study in primary sclerosing cholangitis, another chronic liver disorder. The FDA subsequently placed a formal clinical hold on the drug. The hold also stalled the development of the drug in PBC. The FDA cleared the company to resume testing of the drug in 2020, but CymaBay elected to continue development only in PBC. PBC is a chronic disorder that mainly affects women over the age of 40, impairing liver function. Common early symptoms include severe pruritus (itching) and fatigue. PBC can progress to cirrhosis and liver failure. The first-line drug treatment for PBC is ursodeoxycholic acid, or ursodiol, an old drug for dissolving gallstones that in 1996 won an additional approval as a treatment for PBC. The Intercept Pharmaceuticals drug Ocaliva was approved in 2016 as a second-line therapy for PBC. Intercept, which was acquired late last year by Italian company Alfasigma, reported $240.4 million in sales for the drug in the nine months ended Sept. 30, 2023. CymaBay’s seladelpar is a small molecule designed to bind to and activate peroxisome proliferator activated receptor delta (PPAR delta), a receptor that regulates genes involved in the synthesis of bile acids, metabolism, inflammation, and fibrosis. In its placebo-controlled Phase 3 clinical trial, results showed treatment with the drug led to statistically significant normalization of enzymes indicative of liver disease as well as improvement in pruritus. Late last year, CymaBay submitted a new drug application seeking approval of seladelpar as a treatment for patients who are inadequate responders to or intolerant of ursodiol. CymaBay announced Monday that the FDA will evaluate the application under priority review, setting an Aug. 14 target date for a regulatory decision. Gilead’s portfolio of liver disease drugs include the hepatitis B drugs Vemlidy and Viread as well as hepatitis C drug Harvoni. The Foster City, California-based drugmaker is also in the chase for NASH (now also called MASH, for metabolic associated steatohepatitis) with cilofexor and firsocostat, which are in Phase 2 testing as part of a combination treatment with Novo Nordisk’s semaglutide. “Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement. CymaBay licensed seladelpar from Johnson & Johnson in a 2006 deal. If it’s approved, J&J is in line to receive royalties from sales. The CymaBay pipeline also includes MBX-2982, a molecule in Phase 2a testing for treating hypoglycemia in patients with type 1 diabetes. In a note sent to investors, William Blair analyst Andy Hsieh wrote that the CymaBay acquisition validates the clinical performance and commercial potential of seladelpar in PBC. He called the acquisition “poetic closure” for the company following the molecule’s previous clinical trial setbacks “We commend management’s resilience and persistence that ultimately led to seladelpar demonstrating the best-in-class clinical profile in PBC, and we expect the drug to benefit thousands of patients living with PBC as soon as later this year,” Hsieh said. Hsieh said the Gilead offer is fair and it is unlikely another bidder will emerge. The transaction requires the majority of CymaBay shareholders to tender their shares. The companies expect to close the transaction in the current quarter.

Phase 2AcquisitionClinical ResultPhase 3Drug Approval

06 Sep 2023

·www.biospace.com

Nimbus Secures $210M in Private Funding on Heels of $4B Takeda Deal

Pictured: Illustration of money exchanging hands/iStock, MagicVectorCreation Nimbus Therapeutics announced Wednesday that it raised $210 million to advance its next wave of small-molecule medicines, making it one of 2023’s larger rounds of private financing. The Boston biotech company will be putting the cash towards a variety of initiatives including its ongoing clinical development of NDI-101150, a hematopoietic progenitor kinase 1 inhibitor in patients with solid tumors. New programs are targeting Werner syndrome helicase and an as-yet undisclosed immune target, as well as novel targeted therapies that activate adenosine monophosphate-activated protein kinase (AMPK) to treat metabolic disorders in a nearly $500 million deal with Eli Lilly. This is not Nimbus’ first successful round of fundraising. The company raised $125 million in late 2022, bringing in Bain Life Sciences and SV Health Investors. The latest funding drive announcement on Wednesday brought in some big new investors as well as some old standbys. In particular, the funding round was co-led by Google Ventures—a new investor to Nimbus—as well as existing investors SR One and Atlas Venture. The funding round also brought in another unnamed investor, which Nimbus described in the announcement as “a U.S.-based life sciences-focused fund,” alongside existing investors including Bain Capital Life Sciences, BVF Partners, Gates Frontier, Lightstone Ventures, Pfizer Ventures, RA Capital Management and SV Health Investors. It’s one of the bigger investments in biopharma this year. The industry has seen significant ups and downs in recent years: 2021 was a banner year, building off enthusiasm for COVID-19 vaccines and treatments, before a serious drop-off occurred in 2022. This fundraising round marks the latest good news for Nimbus. At the close of 2022, Phase IIb data for NDI-034858, an allosteric tyrosine 2 kinase inhibitor being developed to treat autoimmune disease, showed that it had met its primary efficacy endpoint—a statistically significant increase in the number of patients hitting a 75% improvement in skin lesions. Two weeks later, Takeda announced it would be buying both the Nimbus therapy and wholly-owned subsidiary Nimbus Lakshmi. Nimbus CEO Jeb Keiper said at the time the results demonstrated NDI-034858 had “the potential to be a best-in-class medicine in multiple disease areas.” The initial $4 billion deal could be worth as much as $6 billion: two milestone payments of $1 billion each kick in at $4 billion and $5 billion in annual net drug sales. Keiper told BioSpace at the time that Nimbus’ focus was on designing breakthrough medicines before partnering with multinational pharma companies to bring them to commercialization. They inked a similar deal in 2016, when Gilead Sciences acquired the company’s lead clinical program, firsocostat, in nonalcoholic steatohepatitis. Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

Phase 2AcquisitionClinical ResultVaccine

26 Jun 2023

·www.prnewswire.com

Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023

HANGZHOU and SHAOXING, China, June 25, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces the poster presentation of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B (CHB) patients with 12-week treatment at European Association for the Study of the Liver (EASL) CONGRESS 2023. The summary of the abstract is shown as below: Title: A phase 2 study of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B patients with 12-week treatment Presenter: Jinzi J. Wu, Ph.D. Principal Investigator: Prof. Jinlin Hou, Nanfang Hospital of Southern Medical University Poster Number: SAT-201 Category: Viral Hepatitis B and D Study Design: This Phase 2 trial (NCT05107778) was a multi-center, randomized, single-blind, placebo-controlled study conducted in China. Forty-three HBeAg negative, hepatitis B virus (HBV) DNA Results: In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. One subject in 15 mg ASC42 cohort experienced a grade 3 serious AE (SAE) of liver function injury with a final outcome of recovered. Pruritus is the most common AE, and study drug-related pruritus was reported in 1 (6.7%), 7 (50%) and 0 (0%) subjects in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively. Pruritus rate of 10 mg ASC42 (6.7%) is lower than other FXR agonists in non-alcoholic steatohepatitis (NASH) patients. Conclusion: In CHB patients, 12-week treatment of 10 mg ASC42 in combination of PEG-IFN-α-2a and ETV was safe and well-tolerated and showed minimum and mild pruritus (6.7%). Previous study indicated that in healthy subjects, 14-day treatment of ASC42 alone demonstrated 471%~1,780% increase of fibroblast growth factor 19 (FGF19) and 53%~91% decrease of 7α-hydroxy-4-cholesten-3-one (C4) at a dose range of 5 mg~15 mg. Data suggest that at the therapeutic dose of 10 mg, the novel FXR agonist ASC42 is differentiated from other FXR agonists in terms of pruritus. [1]. Data on file [2]. Younossi Z.M., Ratziu V., Loomba R., et al. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial [J]. The Lancet, 2019, 394(10215): 2184-96.DOI: 10.1016/s0140-6736(19)33041-7 [3]. Lau G.K., Piratvisuth T., Luo K.X., et al. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B [J]. N Engl J Med, 2005, 352(26): 2682-95.DOI: 10.1056/NEJMoa043470 [4]. Loomba R., Noureddin M., Kowdley K.V., et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH [J]. Hepatology, 2021, 73(2): 625-43.DOI: 10.1002/hep.31622 [5]. Anstee Q.M., Lucas K.J., Francque S., et al. Tropifexor plus cenicriviroc combination versus monotherapy in non-alcoholic steatohepatitis: Results from the Phase 2b TANDEM study [J]. Hepatology, 2023.DOI: 10.1097/hep.0000000000000439 About EASL EASL, the European Association for the Study of the Liver, founded in 1966, is a medical association dedicated to pursuing excellence in liver research, to the clinical practice of liver disorders, and to providing education to all those interested in hepatology. As of 2022, EASL serves 4,900 members from 112 countries. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 23 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . SOURCE Ascletis Pharma Inc.

Clinical ResultPhase 2Phase 3

100 Deals associated with Firsocostat

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D11640	-	-	DB16166

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Compensated cirrhosis	Phase 2	US	Gilead Sciences, Inc.	21 Mar 2018
Compensated cirrhosis	Phase 2	AU	Gilead Sciences, Inc.	21 Mar 2018
Compensated cirrhosis	Phase 2	CA	Gilead Sciences, Inc.	21 Mar 2018
Compensated cirrhosis	Phase 2	HK	Gilead Sciences, Inc.	21 Mar 2018
Compensated cirrhosis	Phase 2	NZ	Gilead Sciences, Inc.	21 Mar 2018
Compensated cirrhosis	Phase 2	PR	Gilead Sciences, Inc.	21 Mar 2018
Fibrosis	Phase 2	US	Gilead Sciences, Inc.	21 Mar 2018
Fibrosis	Phase 2	AU	Gilead Sciences, Inc.	21 Mar 2018
Fibrosis	Phase 2	CA	Gilead Sciences, Inc.	21 Mar 2018
Fibrosis	Phase 2	HK	Gilead Sciences, Inc.	21 Mar 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03987074 (Pubmed \| J Hepatol) Manual	Phase 2	Nonalcoholic Steatohepatitis	108	Semaglutide+Cilofexor tromethamine	hqfzvnujtd(qllbwsmgac) = Treatments were well tolerated - the incidence of adverse events was similar across groups (73-90%) and most events were gastrointestinal in nature. hhgbhgxxuy (thlauqrprw ) View more	Positive	16 Apr 2022
				Semaglutide+Firsocostat+Cilofexor tromethamine
NCT02781584 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 2	Hypertriglyceridemia \| Nonalcoholic Steatohepatitis	66	Fenofibrate+Cilofexor tromethamine+FirsocostatFirsocostat	okrpnrbcez(anhtpbtlun) = most treatment-emergent adverse events were Grade 1 to 2 severity jpwyarvjkb (ljndiyldgw ) View more	Positive	06 Jan 2022
				Icosapent Ethyl+Cilofexor tromethamine+Firsocostat
NCT03987074 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	109	Semaglutide (Semaglutide)	lcikyhjduu(udtezecace) = yywwoclewr knercavfkw (tygytucnam, ipdlceytgp - dkiptgiowm) View more	-	15 Jul 2021
				Semaglutide+Firsocostat (Semaglutide + Firsocostat 20 mg)	lcikyhjduu(udtezecace) = zmjgserwgx knercavfkw (tygytucnam, weobuypbrl - yfechsfseb) View more
NCT03449446 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis \| Compensated cirrhosis	395	Placebo to match SEL	gnjdbkhsgo(tdgbgjtlfl) = hjrcsdajts stagvpsrdm (nmfoqgyfvx, oxtvaqinrw - vgahwmtzik) View more	-	03 Dec 2020
NCT02856555 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	127	placebo+Firsocostat (Firsocostat 5 mg)	fssffninif(akauzgdgdz) = gfmivvsmcx kgzyrfezmw (adretstawz, hldrqirqyn - rljpakwkhs) View more	-	24 Jul 2020
				placebo+Firsocostat (Firsocostat 20 mg)	fssffninif(akauzgdgdz) = epwkvrkwuh kgzyrfezmw (adretstawz, evhefajarz - lybjksiyes) View more
EASL2019	Not Applicable	Nonalcoholic Steatohepatitis	20	GS-0976 20 mg + GS-9674 30 mg	wfmoywbxjp(othrffnfiw) = dvbrjksmdb wxmfuumnip (jxqsrwiskn ) View more	-	13 Apr 2019
				GS-0976 20 mg	wfmoywbxjp(othrffnfiw) = zllzxogbod wxmfuumnip (jxqsrwiskn ) View more
NCT02856555 (Pubmed \| J Laparoendosc Adv Surg Tech A)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	126	GS-0976 20 mg	vsdcglzaiu(qggnyzfouv) = pwufgmxnjv gccfqjnrxh (dfublmrthn )	-	01 Nov 2018

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