{"id":47785,"date":"2022-08-30T08:01:41","date_gmt":"2022-08-30T06:01:41","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/poxel-announces-positive-results-from-phase-2-nash-trial-destiny-1-for-pxl065-a-novel-proprietary-deuterium-stabilized-r-stereoisomer-of-pioglitazone\/"},"modified":"2022-08-30T08:01:41","modified_gmt":"2022-08-30T06:01:41","slug":"poxel-announces-positive-results-from-phase-2-nash-trial-destiny-1-for-pxl065-a-novel-proprietary-deuterium-stabilized-r-stereoisomer-of-pioglitazone","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/poxel-announces-positive-results-from-phase-2-nash-trial-destiny-1-for-pxl065-a-novel-proprietary-deuterium-stabilized-r-stereoisomer-of-pioglitazone\/","title":{"rendered":"Poxel Announces Positive Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, A Novel, Proprietary Deuterium-Stabilized R-Stereoisomer of Pioglitazone"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<b>The Phase 2 trial for the treatment of NASH met its primary efficacy endpoint; PXL065-treated patients achieved statistically significant improvements in the relative decrease in liver fat content measured by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) at 36-weeks for all doses.<\/b>\n<\/li>\n<li>\n<b>Key secondary measures in PXL065-treated patients included a statistically significant improvement in Pro-C3, a biomarker of fibrogenesis.<\/b>\n<\/li>\n<li>\n<b>PXL065 was observed to be safe and well tolerated with no dose dependent increase in body weight and no increased lower extremity edema vs. placebo. Safety profile is consistent with reduced PPARg-mediated side effects vs. published results of pioglitazone.<\/b>\n<\/li>\n<li>\n<b>Histology results pending in September, along with the positive initial readout, will inform the next steps of PXL065 in NASH, including the potential for Phase 3 development.<\/b>\n<\/li>\n<\/ul>\n<p>LYON, France&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.poxel.com%2F&amp;esheet=52837841&amp;newsitemid=20220829005747&amp;lan=en-US&amp;anchor=POXEL+SA&amp;index=1&amp;md5=62d4dd28c015a520f4fd7aea58a46a59\" rel=\"nofollow noopener\" shape=\"rect\">POXEL SA<\/a> (Euronext : POXEL &#8211; FR0012432516), clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced positive top-line results for DESTINY-1 (Deuterium-stabilized R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH), the dose-ranging Phase 2 trial of PXL065 for the treatment of NASH. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which has reduced PPAR<span>\u03b3<\/span> activity but retains non-genomic thiazolidinedione (TZD) actions.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220829005747\/en\/729413\/4\/Logo_Without_Background.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220829005747\/en\/729413\/21\/Logo_Without_Background.jpg\"><\/a><\/p>\n<p>\n<i>\u201cPioglitazone has a good record of efficacy in NASH with 6 clinical trials in NASH patients to-date having demonstrated substantial benefits on liver histology that compare favorably to other oral molecules in development,\u201d <\/i>said Stephen Harrison, MD, President, Summit Clinical Research.<i> \u201cDESTINY-1 was designed to show that PXL065 could achieve a similar efficacy profile as PPAR<\/i><i><span>\u03b3<\/span><\/i><i> targets, but with reduced adverse effects of body weight increase and edema. As the principal investigator of this important trial, I am pleased by the data we\u2019ve seen so far and am looking forward to reviewing the pending histology results soon.\u201d<\/i>\n<\/p>\n<p>\n<i>\u201c<\/i><i>The data we\u2019ve seen to-date support our hypothesis \u2013 that deuterium modification of the pioglitazone R-enantiomer produces differentiated pharmacology \u2013 by reducing PPAR<\/i><i><span>\u03b3<\/span><\/i><i> activity and related adverse effects while retaining aspects of pioglitazone-like efficacy,\u201d <\/i>said Pascale Fouqueray, MD, PhD, Executive Vice President, Clinical Development and Regulatory Affairs at Poxel.<i> \u201cPositive effects on liver fat content and a well-recognized biomarker of fibrogenesis are reassuring. We are excited to soon review the histology results from this study.\u201d<\/i>\n<\/p>\n<p>\n<i>\u201cThese <\/i><i>Phase 2 results in NASH are an important milestone for Poxel and add to our track record of executing successful clinical trials. With the addition of the histology data from the DESTINY-1 trial, PXL065 could be advanced into a pivotal Phase 3 program for NASH \u2013 representing a large unmet need and market opportunity,\u201d <\/i>stated Thomas Kuhn, Chief Executive Officer of Poxel. <i>\u201cToday\u2019s results also validate the concept of the d-TZD platform, which could be utilized in additional diseases such as ALD. We remain fully committed to improve the health and well-being of patients through the development of innovative treatments for serious chronic metabolic diseases.\u201d<\/i>\n<\/p>\n<p>\n<b>Summary of Phase 2 NASH (DESTINY-1) PXL065 Study Results<\/b>\n<\/p>\n<p>\nDESTINY-1 is a Phase 2, 36-week, randomized, dose-ranging, double-blind, placebo-controlled, parallel group study designed to assess the efficacy and safety of PXL065 in patients with noncirrhotic biopsy-proven NASH across multiple clinical sites in the US. The primary endpoint of the study measured the relative change in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). The study also assessed the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers. Histology results are expected in September.\n<\/p>\n<p>\nTop-line results available at present include:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n117 subjects were randomized to one of 4 daily (QD) treatment arms (7.5 mg, 15 mg, 22.5 mg, placebo).\n<\/li>\n<li>\nThe primary efficacy endpoint was achieved: a statistically significant (p=0.024 to p=0.008) mean relative decrease vs. placebo of 21% to 25% in liver fat content from baseline to 36 weeks was observed at all PXL065 doses. 40% of patients who received PXL065 at the 22.5 mg dose achieved a &gt;30% relative reduction in liver fat content.\n<\/li>\n<li>\nNon-invasive biomarker results to-date included: dose-dependent decreases in fibrogenesis markers Pro-C3 (significant vs. placebo at the 22.5 mg dose; p=0.02) and enhanced liver fibrosis (ELF) index. Trends in least-square mean ALT decreases up to 18.4 IU\/L vs. baseline were observed. However, this parameter did not reach statistical significance. Further data analysis is ongoing.\n<\/li>\n<li>\nThere was no dose dependent increase in body weight: a minimal least-square mean increase of 0.68 kg was observed at the top dose of 22.5 mg vs. placebo. The incidence of edema did not show an observed treatment or dose relation when compared to placebo. With respect to other safety measures, PXL065 was observed to be generally safe and well tolerated; the number of patients presenting with treatment-emergent serious adverse events (TESAEs) were similar among all groups including placebo without dose effect.\n<\/li>\n<li>\nAs predicted, pharmacokinetic measurements showed dose-proportional drug levels with the desired degree of higher exposure to the pioglitazone R-stereoisomer and reduced exposure to the (PPARg active) S-stereoisomer.\n<\/li>\n<\/ul>\n<p>\nAdditional data from histology results are expected in September. The full Phase 2 results will be submitted for presentation at an upcoming scientific meeting.\n<\/p>\n<p>\n<b>About PXL065<\/b>\n<\/p>\n<p>\nPXL065 is a novel, proprietary deuterium-stabilized R-pioglitazone. Although pioglitazone is not approved by the FDA for the treatment of NASH, it is the most extensively studied drug for NASH and has demonstrated \u201cresolution of NASH without worsening of fibrosis\u201d in a Phase 4 trial<sup>1<\/sup>. Pioglitazone is the only drug recommended for biopsy-proven NASH patients by the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL)<sup>2<\/sup>.<sup> <\/sup>Pioglitazone\u2019s off-label use for NASH, however, has been limited due to the PPAR\u03b3-related side effects, which include weight gain, bone fractures and fluid retention.\n<\/p>\n<p>\nPioglitazone is a 1:1 mixture of two mirror-image compounds (R- and S-stereoisomers) that interconvert <i>in vivo<\/i>. Using deuterium, Poxel stabilized each stereoisomer and characterized their different pharmacological properties. In <i>in vitro<\/i> studies, PXL065 has been shown to target non-genomic pathways including mitochondrial pyruvate carrier (MPC) and acyl-CoA synthetase 4 (ACSL4). In preclinical animal models, PXL065 exhibits the anti-inflammatory and NASH activity associated with pioglitazone with little or no weight gain or fluid retention, side effects which are associated with the S-stereoisomer<sup>3<\/sup>. NASH Phase 2 (DESTINY 1 trial) results available to-date show statistically significant effects of PXL065 on liver fat content and a biomarker of liver fibrogenesis. Relative to published data for pioglitazone, reduced potential for weight gain and edema was also evident. Based upon preclinical, Phase 1 and preliminary Phase 2 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH and may also have suitable properties for further development in other indications including adrenoleukodystrophy (ALD).\n<\/p>\n<p>\n<b>About NASH<\/b>\n<\/p>\n<p>\nNon-alcoholic steatohepatitis (NASH) is a metabolic disease with no clear disease origin that is quickly becoming a worldwide epidemic. It is characterized by the accumulation of fat in the liver causing inflammation and fibrosis. The disease can be silent for a long period of time, but once it accelerates, severe damage and liver cirrhosis can occur, which can significantly impact liver function or can even result in liver failure or liver cancer. Typical risk factors for NASH include obesity, elevated levels of blood lipids (such as cholesterol and triglycerides) and type 2 diabetes. Currently no curative or specific therapies are available.\n<\/p>\n<p>\n<b>About Poxel SA<\/b>\n<\/p>\n<p>\nPoxel is a <b>clinical stage biopharmaceutical company<\/b> developing <b>innovative treatments for chronic serious diseases with metabolic pathophysiology<\/b>, including <b>non-alcoholic steatohepatitis (NASH)<\/b> and rare disorders. Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated TZD platforms targeting chronic and rare metabolic diseases. For the treatment of NASH, <b>PXL065<\/b> (deuterium-stabilized <i>R<\/i>-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). <b>PXL770<\/b>, a first-in-class direct AMPK activator, has successfully completed a Phase 2a proof-of-concept trial for the treatment of NASH, which met its objectives<i>. <\/i>For the rare inherited metabolic disorder, adrenoleukodystrophy (ALD), the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN). <b>TWYMEEG<sup>\u00ae<\/sup><\/b> (Imeglimin), Poxel\u2019s first-in-class lead product that targets mitochondrial dysfunction, is approved and marketed for the treatment of type 2 diabetes in Japan<i>.<\/i> Poxel expects to receive from Sumitomo Pharma royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.\n<\/p>\n<p>\nFor more information, please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.poxelpharma.com&amp;esheet=52837841&amp;newsitemid=20220829005747&amp;lan=en-US&amp;anchor=www.poxelpharma.com&amp;index=2&amp;md5=ab95efd11e98c9cd81b4376091c109b4\" rel=\"nofollow noopener\" shape=\"rect\">www.poxelpharma.com<\/a>\n<\/p>\n<p>\nAll statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company\u2019s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as \u201ctarget,\u201d \u201cbelieve,\u201d \u201cexpect,\u201d \u201caim,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cplan,\u201d \u201cproject,\u201d \u201cwill,\u201d \u201ccan have,\u201d \u201clikely,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccould\u201d and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company\u2019s control that could cause the Company\u2019s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.\n<\/p>\n<p>\n<sup>1<\/sup> Cusi, et al., Ann Intern Med. 2016, 165(5), 305-315).<br \/>\n<br \/><sup>2<\/sup> J Hepatol. 2016, 64(6),1388-402; Hepatology 2018, 67, 328-357.<br \/>\n<br \/><sup>3<\/sup> Jacques et al. Deuterium\u2010Stabilized (R)\u2010Pioglitazone (PXL065) is responsible for pioglitazone efficacy in NASH yet exhibits little to no PPAR\u03b3 activity\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Investor relations \/ Media<\/b><br \/>Aur\u00e9lie Bozza<br \/>\n<br \/>Investor Relations &amp; Communication Senior Director<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x61;&#x75;r&#x65;&#108;i&#x65;&#46;&#x62;&#111;z&#x7a;&#97;&#64;&#x70;&#111;&#x78;&#101;l&#x70;&#104;&#x61;&#x72;m&#x61;&#46;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x61;&#x75;&#x72;&#101;&#108;ie&#x2e;&#x62;&#x6f;&#x7a;&#122;&#97;&#64;p&#x6f;&#x78;&#x65;&#108;&#112;&#104;ar&#x6d;&#x61;&#x2e;&#99;&#111;m<\/a><br \/>+33 6 99 81 08 36\n<\/p>\n<p>\nElizabeth Woo<br \/>\n<br \/>Senior Vice President, Investor Relations &amp; Communication<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#97;&#x69;&#x6c;&#116;&#111;&#x3a;&#x65;&#108;&#105;&#x7a;&#x61;&#98;&#101;&#x74;&#x68;&#46;&#119;&#x6f;&#x6f;&#64;&#112;&#x6f;&#x78;&#101;&#108;&#x70;&#x68;&#97;&#114;&#x6d;&#x61;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#101;&#x6c;i&#122;&#x61;b&#101;&#x74;h&#46;&#x77;o&#111;&#x40;p&#111;&#x78;e&#108;&#x70;h&#97;&#x72;m&#97;&#x2e;c&#111;&#x6d;<\/a>\n<\/p>\n<p>\nNewCap<br \/>\n<br \/>Emmanuel Huynh or Arthur Rouill\u00e9<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#111;&#x3a;&#112;&#x6f;x&#x65;l&#64;&#x6e;&#101;&#x77;c&#x61;&#x70;&#46;&#x65;u\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#x6f;&#120;&#101;l&#x40;&#x6e;&#x65;&#119;ca&#x70;&#x2e;&#101;&#117;<\/a><br \/>+33 1 44 71 94 94\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Phase 2 trial for the treatment of NASH met its primary efficacy endpoint; PXL065-treated patients achieved statistically significant improvements in the relative decrease in liver fat content measured by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) at 36-weeks for all doses. Key secondary measures in PXL065-treated patients included a statistically significant improvement &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/poxel-announces-positive-results-from-phase-2-nash-trial-destiny-1-for-pxl065-a-novel-proprietary-deuterium-stabilized-r-stereoisomer-of-pioglitazone\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47785","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Poxel Announces Positive Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, A Novel, Proprietary Deuterium-Stabilized R-Stereoisomer of Pioglitazone - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/poxel-announces-positive-results-from-phase-2-nash-trial-destiny-1-for-pxl065-a-novel-proprietary-deuterium-stabilized-r-stereoisomer-of-pioglitazone\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Poxel Announces Positive Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, A Novel, Proprietary Deuterium-Stabilized R-Stereoisomer of Pioglitazone - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"The Phase 2 trial for the treatment of NASH met its primary efficacy endpoint; PXL065-treated patients achieved statistically significant improvements in the relative decrease in liver fat content measured by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) at 36-weeks for all doses. Key secondary measures in PXL065-treated patients included a statistically significant improvement ... 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