Galectin Therapeutics Broadcasts the Finish of Enrollment of NAVIGATE, its Seamless, Adaptive Part 2b/3 Research of Belapectin in Sufferers with Liver Cirrhosis Brought on by Non-Alcoholic Steatohepatitis
NORCROSS, Ga., Jan. 05, 2023 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ: GALT), the main developer of therapeutics that concentrate on galectin-3, introduced immediately that in late December 2022, it ended enrollment of NAVIGATE, its seamless, adaptive, section 2b/3 examine of belapectin in sufferers with liver cirrhosis attributable to non-alcoholic steatohepatitis (NASH). NAVIGATE is the primary examine of its variety and is a world effort that recruited sufferers in 14 international locations and on 5 continents. The primary efficacy goal is the first prevention of esophageal varices. Sufferers enrolled within the examine have cirrhosis attributable to NASH and, due to the advancing cirrhotic course of, have already developed portal hypertension however haven’t but developed dilated veins within the esophagus generally known as esophageal varices, a complication of portal hypertension. Portal hypertension is the consequence of the unrelented inflammatory and fibrotic course of occurring within the liver and dramatically will increase the danger of growing esophageal varices, a doubtlessly life-threatening complication of liver cirrhosis.
Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, stated: “the Part 2b portion of NAVIGATE was designed to review roughly 315 sufferers, randomized (1 to 1 to 1) both to 2 mg/kg of Lean Physique Mass (LBM) or 4 mg/kg LBM of belapectin or placebo. We have been happy to shut out the screening for this trial in December 2022. At present, 309 sufferers have been randomized, and with the remaining sufferers in screening complete randomizations are anticipated to succeed in 325 to 340 sufferers. The ultimate affected person is anticipated to be randomized no later than early March. The therapy interval is eighteen months; due to this fact, the outcomes of the interim evaluation are anticipated within the fourth quarter of 2024.”
Dr. Stephen A. Harrison, co-principal investigator for NAVIGATE and Chairman, Summit Medical Analysis, acknowledged: “finishing enrollment in NAVIGATE is a crucial milestone. This can be a essential examine for sufferers with NASH cirrhosis. Demonstrating prevention of development to esophageal varices in these sufferers has essential implications for long-term affected person outcomes. As well as, the first consequence measure of efficacy, versus liver biopsies, is each sensible and clinically related.”
Mr. Joel Lewis, the Firm’s president and Chief Government Officer stated: “we’re gratified to succeed in this essential milestone. Finishing enrollment will enable us to deal with effectively executing our program and different acknowledged targets for this yr. I wish to personally thank our investigators and their groups, together with all of the sufferers within the trial for taking part on this modern examine.”
About Belapectin
Belapectin is a posh carbohydrate drug that targets galectin-3, a essential protein within the pathogenesis of NASH and fibrosis. Galectin-3 performs a significant position in illnesses that contain scarring of organs, together with fibrotic issues of the liver, lung, kidney, coronary heart and vascular system. Belapectin binds to galectin-3 and disrupts its operate. Preclinical knowledge in animals have proven that belapectin has strong therapy results in reversing liver fibrosis and cirrhosis. A Part 2 examine confirmed belapectin could forestall the event of esophageal varices in NASH cirrhosis, and these outcomes present the premise for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled “A Seamless Adaptive Part 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, Worldwide Research Evaluating the Efficacy and Security of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis,” is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a major position in most cancers, and the Firm has supported a Part 1b examine in mixed immunotherapy of belapectin and KEYTRUDA in superior melanoma and in head and neck most cancers. This trial offered a powerful rationale for shifting ahead right into a Firm-sponsored Part 2 improvement program, which the corporate is exploring.
About Fatty Liver Illness with Superior Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH) has turn out to be a standard illness of the liver with the rise in weight problems and different metabolic illnesses. NASH is estimated to have an effect on as much as 28 million folks within the U.S. It’s characterised by the presence of extra fats within the liver together with irritation and hepatocyte injury (ballooning) in individuals who devour little or no alcohol. Over time, sufferers with NASH can develop extreme fibrosis, or scarring of the liver, and in the end liver cirrhosis. It’s estimated that as many as 1 to 2 million people within the U.S. will develop cirrhosis on account of NASH, for which liver transplantation is the one healing therapy accessible. Roughly 9,000 liver transplants are carried out yearly within the U.S. There aren’t any drug therapies authorised for the therapy of liver fibrosis or cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is devoted to growing novel therapies to enhance the lives of sufferers with power liver illness and most cancers. Galectin’s lead drug belapectin (previously generally known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein, which is instantly concerned in a number of inflammatory, fibrotic, and malignant illnesses, for which it has Quick Monitor designation by the U.S. Meals and Drug Administration. The lead improvement program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, probably the most superior type of NASH-related fibrosis. That is the commonest liver illness and one of many largest drug improvement alternatives accessible immediately. Extra improvement packages are in therapy of mixture immunotherapy for superior melanoma and different malignancies. Development of those extra scientific packages is essentially depending on discovering an acceptable accomplice. Galectin seeks to leverage in depth scientific and improvement experience in addition to established relationships with exterior sources to realize cost-effective and environment friendly improvement. Extra data is obtainable at www.galectintherapeutics.com.
Ahead Trying Statements
This press launch comprises forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995. These statements relate to future occasions or future monetary efficiency, and use phrases reminiscent of “could,” “estimate,” “might,” “anticipate” and others. They’re based mostly on administration’s present expectations and are topic to components and uncertainties that might trigger precise outcomes to vary materially from these described within the statements. These statements embrace these relating to the hope that Galectin’s improvement program for belapectin will result in the primary remedy for the therapy of fatty liver illness with cirrhosis and people relating to the hope that our lead compounds might be profitable in most cancers immunotherapy and in different therapeutic indications. Elements that might trigger precise efficiency to vary materially from these mentioned within the forward-looking statements embrace, amongst others, findings of security of a drug candidate are usually not indicative of the drug candidate’s efficacy; that trial endpoints required by the FDA is probably not achieved; Galectin is probably not profitable in growing efficient remedies and/or acquiring the requisite approvals for the usage of belapectin or any of its different medicine in improvement; the Firm is probably not profitable in scaling up manufacturing and assembly necessities associated to chemistry, manufacturing and management issues; the Firm’s present scientific trial and any future scientific research as modified to satisfy the necessities of the FDA could not produce constructive leads to a well timed style, if in any respect, and will require bigger and longer trials, which might be time consuming and dear; plans relating to improvement, approval and advertising of any of Galectin’s medicine are topic to alter at any time based mostly on the altering wants of the Firm as decided by administration and regulatory businesses; whatever the outcomes of any of its improvement packages, Galectin could also be unsuccessful in growing partnerships with different firms or elevating extra capital that will enable it to additional develop and/or fund any research or trials. Galectin has incurred working losses since inception, and its means to efficiently develop and market medicine could also be impacted by its means to handle prices and finance persevering with operations. International components reminiscent of coronavirus could proceed to affect NASH affected person populations across the globe and additional have an effect on the trial and considerably affect related prices. For a dialogue of extra components impacting Galectin’s enterprise, see the Firm’s Annual Report on Kind 10-Ok for the yr ended December 31, 2021, and subsequent filings with the SEC. You shouldn’t place undue reliance on forward-looking statements. Though subsequent occasions could trigger its views to alter, administration disclaims any obligation to replace forward-looking statements.
Firm Contact:
Jack Callicutt, Chief Monetary Officer
(678) 620-3186
[email protected]
Galectin Therapeutics and its related brand is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned title for Galectin Therapeutics’ galectin-3 inhibitor belapectin (GR-MD-02).
