Sagimet Biosciences Announces Completion of Phase 1 Hepatic Impairment Study with FASN Inhibitor Denifanstat
- Successful completion of Phase 1 hepatic impairment study for denifanstat
- 38 subjects enrolled in the study, including different categories of hepatic impairment
- Denifanstat well-tolerated with no reported safety signals
- Pharmacokinetic results expected to support Phase 3 program for denifanstat in MASH
- None.
The completion of the Phase 1 hepatic impairment study by Sagimet Biosciences for their drug denifanstat is a significant milestone in the drug development process. Denifanstat's potential to treat metabolic dysfunction-associated steatohepatitis (MASH), a condition that currently has few effective treatments, is of particular interest. The successful assessment of the drug in patients with varying degrees of liver impairment is essential, as liver function can significantly affect drug metabolism and safety profiles.
From a research perspective, the absence of safety signals in this early phase is promising. However, the real test of the drug's efficacy and safety will come in later stage trials. The pharmacokinetics data will be important for determining appropriate dosing for patients with different levels of hepatic function. It's important to note that Phase 1 studies are primarily focused on safety and while positive, they do not guarantee success in later phases that assess efficacy more rigorously.
For stakeholders, the progression to Phase 3 trials could mean a significant increase in investment into the company as it moves closer to potential commercialization. However, they should be aware of the risks inherent in drug development, particularly in the competitive field of metabolic diseases, where many drugs fail to make it to market.
Metabolic dysfunction-associated steatohepatitis represents a growing healthcare concern, correlating with the rising prevalence of obesity and type 2 diabetes. The economic implications of introducing a new treatment option like denifanstat could be substantial. Currently, the cost burden of MASH on the healthcare system is significant, due to the lack of targeted therapies and the potential progression to cirrhosis or liver cancer.
If denifanstat proves to be effective, it could reduce long-term healthcare costs by preventing disease progression and the need for more expensive interventions, like liver transplants. Moreover, the development of treatments for MASH is likely to attract attention from healthcare providers and payers looking to manage this costly condition more effectively.
On the other hand, the high costs associated with bringing a new drug to market could lead to a high price tag for denifanstat, which might affect its adoption and reimbursement by insurance companies. Payers will closely scrutinize its cost-effectiveness compared to existing treatments and the overall impact on healthcare expenditure.
The announcement regarding denifanstat's Phase 1 study completion is a key indicator of Sagimet Biosciences' potential trajectory in the pharmaceutical market. The market for MASH treatments is relatively untapped, providing ample opportunity for first-movers like Sagimet. Investors should monitor the development of denifanstat closely, as a successful Phase 3 trial could position the company as a leader in this niche market.
It is important to consider the competitive landscape, as other companies are also aiming to capitalize on the demand for effective MASH therapies. The timing of denifanstat's entry into the market, pending regulatory approval, could be a decisive factor in its market share capture. Additionally, strategic partnerships or licensing agreements could be beneficial in scaling production and distribution capabilities to meet global demand.
Investors should also be mindful of the volatility of biotech stocks, which are highly sensitive to clinical trial outcomes and regulatory news. While the completion of the Phase 1 study is a positive development, the long-term success of Sagimet Biosciences hinges on the outcomes of future trials and the eventual market acceptance of denifanstat.
SAN MATEO, Calif., March 27, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the completion of a Phase 1 hepatic impairment study with denifanstat, a selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
This study was designed to assess the safety and pharmacokinetics of denifanstat in subjects with hepatic impairment, a typical requirement of development programs in MASH. A total of 38 subjects were enrolled and completed this non-randomized, parallel group study. The study population included 8 subjects in each category of mild, moderate or severe hepatic impairment, and 14 healthy subjects with normal hepatic function demographically matched to the subjects with hepatic impairment for age, body weight, and gender. All subjects received oral denifanstat 50 mg once a day for 4 days.
Denifanstat was well-tolerated and no safety signals were reported. The pharmacokinetic results from this study are anticipated to support the planned Phase 3 program for denifanstat in MASH.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.
About MASH
MASH is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to metabolic dysfunction-associated steatohepatitis (MASH). Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions.
The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat or any other drug candidates Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials, including its FASCINATE-2 Phase 3 clinical trial; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact:
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
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