A Randomized Open-label Phase 2a Study to Assess PXL770 After 12 Weeks of Treatment in Male Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

开始日期2023-09-01

申办/合作机构

Poxel SA

NL-OMON51808

/ Withdrawn临床2期

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN) - PXL770-011 / START770

开始日期2022-03-15

申办/合作机构-

NCT05441904

/ Completed临床1期

A Phase I, Two-part, Single and Optional Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 500 and 750 mg PXL770 in Healthy Subjects

The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety, tolerability find out the side effects and blood levels of the PXL770.

开始日期2021-03-08

申办/合作机构

Poxel SA

100 项与 PXL-770 相关的临床结果

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100 项与 PXL-770 相关的转化医学

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100 项与 PXL-770 相关的专利（医药）

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项与 PXL-770 相关的文献（医药）

2023-05-01·Kidney International

A novel direct adenosine monophosphate kinase activator ameliorates disease progression in preclinical models of Autosomal Dominant Polycystic Kidney Disease

Article

作者: Steinberg, Gregory R ; Hallakou-Bozec, Sophie ; Blockken, Laura ; Kraus, Andre ; Buchholz, Bjoern ; Dagorn, Pascale Gluais ; Batchuluun, Battsetseg ; Bange, Hester ; Moller, David E

Autosomal dominant polycystic kidney disease (ADPKD) mainly results from mutations in the PKD1 gene, which encodes polycystin 1. It is the most common inherited kidney disease and is characterized by a progressive bilateral increase in cyst number and size, often leading to kidney failure. The cellular energy sensor and regulator adenosine monophosphate stimulated protein kinase (AMPK) has been implicated as a promising new therapeutic target. To address this hypothesis, we determined the effects of a potent and selective clinical stage direct allosteric AMPK activator, PXL770, in canine and patient-derived 3D cyst models and an orthologous mouse model of ADPKD. PXL770 induced AMPK activation and dose-dependently reduced cyst growth in principal-like Madin-Darby Canine Kidney cells stimulated with forskolin and kidney epithelial cells derived from patients with ADPKD stimulated with desmopressin. In an inducible, kidney epithelium-specific Pkd1 knockout mouse model, PXL770 produced kidney AMPK pathway engagement, prevented the onset of kidney failure (reducing blood urea by 47%), decreased cystic index by 26% and lowered the kidney weight to body weight ratio by 35% compared to untreated control Pkd1 knockout mice. These effects were accompanied by a reduction of markers of cell proliferation (-48%), macrophage infiltration (-53%) and tissue fibrosis (-37%). Thus, our results show the potential of direct allosteric AMPK activation in the treatment of ADPKD and support the further development of PXL770 for this indication.

2022-08-01·The Journal of Pharmacology and Experimental Therapeutics

Beneficial Effects of the Direct AMP-Kinase Activator PXL770 in In Vitro and In Vivo Models of X-Linked Adrenoleukodystrophy

Article

作者: Parasar, Parveen ; Singh, Jaspreet ; Moller, David E ; Theurey, Pierre ; Monternier, Pierre-Axel ; Bolze, Sébastien ; Gluais Dagorn, Pascale ; Hallakou-Bozec, Sophie ; Fouqueray, Pascale ; Kaur, Navtej ; Nagaraja, Tavarekere N

X-linked adrenoleukodystrophy (ALD) is a severe orphan disease caused by mutations in the peroxisomal ABCD1 transporter gene, leading to toxic accumulation of Very Long-Chain Fatty Acids (VLCFA - in particular C26:0) resulting in inflammation, mitochondrial dysfunction and demyelination. AMP-activated protein kinase (AMPK) is downregulated in ALD, and its activation is implicated as a therapeutic target. PXL770 is the first direct allosteric AMPK activator with established clinical efficacy and tolerability. Methods: We investigated its effects in ALD patient-derived fibroblasts/lymphocytes and Abcd1 KO mouse glial cells. Readouts included VLCFA levels, mitochondrial function and mRNA levels of proinflammatory genes and compensatory transporters (ABCD2-3). After PXL770 treatment in Abcd1 KO mice, we assessed VLCFA levels in tissues, sciatic nerve axonal morphology by electronic microscopy and locomotor function by open-field/balance-beam tests. Results: In patients' cells and Abcd1 KO glial cells, PXL770 substantially decreased C26:0 levels (by ∼90%), improved mitochondrial respiration, reduced expression of multiple inflammatory genes and induced expression of ABCD2-3 In Abcd1 KO mice, PXL770 treatment normalized VLCFA in plasma and significantly reduced elevated levels in brain (-25%) and spinal cord (-32%) versus untreated (P < 0.001). Abnormal sciatic nerve axonal morphology was also improved along with amelioration of locomotor function. Conclusion: Direct AMPK activation exerts beneficial effects on several hallmarks of pathology in multiple ALD models in vitro and in vivo, supporting clinical development of PXL770 for this disease. Further studies would be needed to overcome limitations including small sample size for some parameters, lack of additional in vivo biomarkers and incomplete pharmacokinetic characterization. SIGNIFICANCE STATEMENT: Adrenoleukodystrophy is a rare and debilitating condition with no approved therapies, caused by accumulation of very long-chain fatty acids. AMPK is downregulated in the disease and has been implicated as a potential therapeutic target. PXL770 is a novel clinical stage direct AMPK activator. In these studies, we used PXL770 to achieve preclinical validation of direct AMPK activation for this disease - based on correction of key biochemical and functional readouts in vitro and in vivo, thus supporting clinical development.

2022-07-01·Molecular Metabolism

Defective AMPK regulation of cholesterol metabolism accelerates atherosclerosis by promoting HSPC mobilization and myelopoiesis

Article

作者: Kemp, Bruce E ; Onda, Danise-Ann ; Murphy, Andrew J ; Lin, Xuzhu ; Cooney, Olivia D ; Loh, Kim ; Galic, Sandra ; Edlund, Thomas ; Meikle, Peter J ; Dragoljevic, Dragana ; Nadarajah, Shaktypreya ; Huynh, Kevin ; Fullerton, Morgan D ; Lee, Man K S

OBJECTIVESDysregulation of cholesterol metabolism in the liver and hematopoietic stem and progenitor cells (HSPCs) promotes atherosclerosis development. Previously, it has been shown that HMG-CoA-Reductase (HMGCR), the rate-limiting enzyme in the mevalonate pathway, can be phosphorylated and inactivated by the metabolic stress sensor AMP-activated protein kinase (AMPK). However, the physiological significance of AMPK regulation of HMGCR to atherogenesis has yet to be elucidated. The aim of this study was to determine the role of AMPK/HMGCR axis in the development of atherosclerosis.METHODSWe have generated a novel atherosclerotic-prone mouse model with defects in the AMPK regulation of HMGCR (Apoe^-/-/Hmgcr KI mice). Atherosclerotic lesion size, plaque composition, immune cell and lipid profiles were assessed in Apoe^-/- and Apoe^-/-/Hmgcr KI mice.RESULTSIn this study, we showed that both male and female atherosclerotic-prone mice with a disruption of HMGCR regulation by AMPK (Apoe^-/-/Hmgcr KI mice) display increased aortic lesion size concomitant with an increase in plaque-associated macrophages and lipid accumulation. Consistent with this, Apoe^-/-/Hmgcr KI mice exhibited an increase in total circulating cholesterol and atherogenic monocytes, Ly6-C^hi subset. Mechanistically, increased circulating atherogenic monocytes in Apoe^-/-/Hmgcr KI mice was associated with enhanced egress of bone marrow HSPCs and extramedullary myelopoiesis, driven by a combination of elevated circulating 27-hydroxycholesterol and intracellular cholesterol in HSPCs.CONCLUSIONSOur results uncovered a novel signalling pathway involving AMPK-HMGCR axis in the regulation of cholesterol homeostasis in HSPCs, and that inhibition of this regulatory mechanism accelerates the development and progression of atherosclerosis. These findings provide a molecular basis to support the use of AMPK activators that currently undergoing Phase II clinical trial such as O-3O4 and PXL 770 for reducing atherosclerotic cardiovascular disease risks.

项与 PXL-770 相关的新闻（医药）

2025-01-31

·Business Wire

Poxel’s partner Sumitomo Pharma reports TWYMEEG® gross sales in Japan for Q4 2024 and FY 2024 sales forecast

LYON, France--( BUSINESS WIRE )--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today reports TWYMEEG ® gross sales in Japan for Q4 2024 and sales forecast shared by its partner Sumitomo Pharma as part of its Q3 FY2024 financial results 1 . “ We believe TWYMEEG ® is an important asset in our existing diabetes franchise and are committed to support its sales trajectory. Based on the safety and tolerability profile observed from TWINKLE study, we are conducting discussions with the regulatory authorities in Japan, on revising TWYMEEG ® package insert for patients with renal impairment, ” stated Koichi Kozuki, Executive Officer, Corporate Regulatory Compliance & Quality Assurance Division, Senior Vice President, Head of Corporate Regulatory Compliance & Quality Assurance Division of Sumitomo Pharma . For the quarter ending December 2024, TWYMEEG ® gross sales in Japan increased by 17% to JPY 2.1 billion (EUR 13 million) 3 over the prior quarter sales of JPY 1.8 billion (EUR 11.2 million)3 as reported by Sumitomo Pharma. As announced on January 20, 2025, TWYMEEG ® achieved JPY 5 billion net sales in Japan in Sumitomo Pharma’s fiscal year 2024 1 , making Poxel eligible for royalties equaling 10% of all TWYMEEG ® net sales for 2024 and a one-time sales-based payment of JPY 500 million (EUR 3.1 million 3 ). Based on the royalty monetization agreement with OrbiMed, these proceeds for FY2024, net of Poxel's obligation to Merck Serono, will be directed to the reimbursement of the bond issue. During FY 2024 1 , Sumitomo Pharma now expects TWYMEEG ® net sales in Japan to reach JPY 7.9 billion (EUR 48.4 million 3 ), compared to the previous forecast of JPY 11.3 billion (EUR 69.2 million 3 ) published on May 14, 2024, which would represent an increase by 72% over FY 2023 sales (JPY 4.6 billion). This revision is driven by Sumitomo Pharma’s internal restructuring initiative as well as an evolving competitive landscape in Japan. To support TWYMEEG ® sales trajectory going forward, Sumitomo Pharma has implemented measures to minimize potential impact from this internal restructuring initiative and continues to work on expanding the TWYMEEG ® package insert. As announced on August 7, 2024, topline results obtained from the post-marketing clinical study, TWINKLE ( TW YMEEG ® in d i abetic patients with re n al impairment: A post-mar k eting l ong-t e rm study) conducted by Sumitomo Pharma in Japanese type 2 diabetic patients with renal impairment confirmed TWYMEEG ® ’s safety and tolerability profile, which is consistent with prior clinical studies in the general type 2 diabetes population. Based on these results, Sumitomo Pharma is conducting discussions with the regulatory authorities in Japan for revising TWYMEEG ® package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m 2 and expects outcome in the first half of 2025. Next Financial Press Release: Fourth Quarter 2024 Cash and Revenue update, on February 19, 2025 About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology , including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770 , a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: www.poxelpharma.com All 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’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” 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’s control that could cause the Company’s 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. Glossary You will find below a list of words and/or expressions that are used in this press release or in Poxel’s communication, with the aim of bringing clarification and transparency: Sumitomo Pharma fiscal year runs April to March. As an example, Fiscal Year 2024 is April 1, 2024, through March 31, 2025. TWYMEEG royalties: As per the Sumitomo Pharma’s agreement, Poxel is entitled to receive royalties from the sales of TWYMEEG (Imeglimin) in Japan Sumitomo Pharma communicates gross sales of TWYMEEG, while TWYMEEG royalties are calculated on net sales. Net sales represent the amount of gross sales to which are deducted potential rebates, allowances, and costs such as prepaid freight, postage, shipping, customs duties and insurance charges. Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG net sales from Sumitomo Pharma. Positive net royalties : as part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG, independent of the level of sales. All royalties that Poxel receives from TWYMEEG net sales above that 8% level are considered as positive net royalties. Net royalties will therefore be positive for Poxel when TWYMEEG net sales exceed JPY 5 billion in a fiscal year and royalties reach 10% and above. 1 Sumitomo Pharma fiscal year 2024 ends March 31, 2025 2 As per Sumitomo Pharma FY2024 forecast published on January 31, 2025 3 Converted at the exchange rate as of December 31, 2025. 4 As per Sumitomo Pharma FY2024 forecast published on May 14, 2024

临床结果引进/卖出财报临床2期

2025-01-20

·Business Wire

Poxel Announces the Grant of Patent in China Protecting the Use of Imeglimin for Type-2 Diabetic Patients with Renal Impairment

LYON, France--( BUSINESS WIRE )--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announced that China's National Intellectual Property Administration (“CNIPA”) has granted Poxel patent ZL201980015603.X for Imeglimin, a first-in-class drug targeting mitochondrial dysfunction and marketed in Japan for the treatment of type-2 diabetes. This new patent protects the use of Imeglimin for type-2 diabetic patients with moderate to severe renal impairment until 2039. The granting of the patent further supports ongoing discussions initiated by Poxel to develop and market Imeglimin in China, following the Company's recovery of the rights to this product in Asian countries other than Japan 1 from Sumitomo Pharma. The Company also holds 3 additional patents in China covering Imeglimin’s synthesis process. The prevalence of diabetic patient with chronic kidney disease is high in China, corresponding to around 27% of the country's diabetic population, or nearly 32 million patients 2 . Diabetes is also the leading cause of end-stage renal failure in this country, i.e. requiring dialysis or a kidney transplant. China is one of Poxel's priority targets for the development and marketing of Imeglimin, where the decisions taken by the Japanese Agency for Pharmaceuticals and Medical Devices, could potentially reduce future regulatory and development times. “ The granting of this patent by the Chinese authorities is in line with our corporate development strategy and represents a partnering opportunity for a biotech company in this strategic territory. Indeed, the medical needs of the Chinese sub-population of type-2 diabetic patients with renal impairment are huge, and this sub-population is in great demand for a safe and efficacious therapeutic solution. We are pursuing our discussions with a view to a strategic partnership for the development and commercialization of Imeglimin, focusing primarily on China, South East Asian countries, as well as other very specific territories enabling us to maximize the approval of Imeglimin already achieved in Japan, thereby reducing the development efforts to be undertaken on a country-by-country basis ”, stated Thomas Kuhn, Chief Executive Officer of Poxel . About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology , including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770 , a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: www.poxelpharma.com All 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’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” 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’s control that could cause the Company’s 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. 1 China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia and Lao People's Democratic Republic. 2 Source: Chen et al. (2009) Nephrol Dial Transplant, Atkins et al. (2005) Kidney International, Robbins (2005) BMC public health

临床2期上市批准临床结果

2025-01-20

·Business Wire

Poxel to receive sales-based payment and higher level of royalties from Sumitomo Pharma in Q1 2025 for TWYMEEG® Achieving JPY 5 billion Net Sales in Japan

LYON, France--( BUSINESS WIRE )--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announced that net sales of TWYMEEG ® in Japan reached JPY 5 billion (EUR 30.6 million 2 ) in Sumitomo Pharma's fiscal year 2024, making Poxel eligible for positive net royalties on net sales of the product and a sales-based payment of JPY 500 million. TWYMEEG ® is Poxel’s first-in-class product marketed for the treatment of type 2 diabetes in Japan. “ We are particularly proud that our product has reached this contractual sales threshold in Japan, paving the way for Poxel to receive positive royalties net of royalties payments to Merck Serono and a sales-based payment from our partner Sumitomo Pharma. Based on the agreement signed between Poxel and OrbiMed in September 2024, these funds will be used to repay the bonds issued to OrbiMed. Given the strong commercial momentum and Sumitomo Pharma's ongoing discussions with the Japanese authorities to revise TWYMEEG ® 's package insert for Type-2 Diabetic patients with renal impairment, we are confident of receiving escalating positive net royalties beyond 2024 ”, stated Thomas Kuhn, Chief Executive Officer of Poxel . Poxel has been informed by its partner Sumitomo Pharma that net sales of TWYMEEG ® in Japan exceeded the contractual threshold of JPY 5 billion (EUR 30.6 million 2 ) as of December 31, 2024, making Poxel eligible for royalties equaling 10% of all TWYMEEG ® net sales achieved in Japan during Sumitomo Pharma's 2024 fiscal year, and a sales-based payment of JPY 500 million (EUR 3.1 million 2 ). In accordance with the royalty monetization agreement signed with OrbiMed in September 2024, all these revenues for fiscal year 2024, after deduction of Poxel's obligation to Merck Serono, i.e. the payment of an 8% fixed royalty based on net sales, will be used to repay the bond issue. In addition, the residual amount of USD 5.0 million (EUR 4.8 million 2 ) from the reserve deposit account opened at the time of the agreement with OrbiMed, from which USD 1.25 million was withdrawn quarterly to repay the bonds issued until OrbiMed received sales-based payments and royalties based on TWYMEEG ® sales in Japan, will be used to repay the debt contracted with IPF Partners. As a result, Poxel expects that as of March 31, 2025, the level of IPF Partners' debt will be around EUR 9.3 million, including the residual amount of EUR 4.8 million from the reserve deposit account and capitalized interest. The Company's cash runway remains until the end of Q1 2025, following the non-adoption of the financial resolutions at the Company's last Combined General Meeting, held on November 28, 2024. Beyond 2024, Poxel expects to receive escalating double-digit royalties, as well as additional sales-based payments upon achievement of contractual based sales thresholds. About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology , including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770 , a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: www.poxelpharma.com All 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’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” 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’s control that could cause the Company’s 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. Glossary You will find below a list of words and/or expressions that are used in this press release or in Poxel’s communication, with the aim to bring clarification and transparency: Sumitomo Pharma fiscal year runs April to March. As an example, Fiscal Year 2024 is April 1, 2024, through March 31, 2025. TWYMEEG royalties: As per the Sumitomo Pharma’s agreement, Poxel is entitled to receive royalties from the sales of TWYMEEG (Imeglimin) in Japan Sumitomo Pharma communicates gross sales of TWYMEEG, while TWYMEEG royalties are calculated on net sales. Net sales represent the amount of gross sales to which are deducted potential rebates, allowances, and costs such as prepaid freight, postage, shipping, customs duties and insurance charges. Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG net sales from Sumitomo Pharma. Positive net royalties : as part of the Merck Serono licensing agreement, Poxel pays Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG, independent of the level of sales. All royalties that Poxel receives from TWYMEEG net sales above that 8% level are considered as positive net royalties. Net royalties will therefore be positive for Poxel when TWYMEEG net sales exceed JPY 5 billion in a fiscal year and royalties reach 10% and above. 1 Sumitomo Pharma fiscal year 2024 ends March 31, 2025 2 Converted at the exchange rate on December 31, 2024

引进/卖出临床2期上市批准

100 项与 PXL-770 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床1期	英国	Poxel SA	2021-03-08
非酒精性脂肪肝	临床1期	美国	Poxel SA	2019-03-29
代谢性疾病	临床1期	英国	Poxel SA	2017-08-21
常染色体显性多囊肾病	临床前	法国	Poxel SA	2023-02-18
肾上腺脑白质营养不良	药物发现	-	Poxel SA	2023-09-01
2型糖尿病	药物发现	法国	Poxel SA	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESC2021	N/A	-	-	PXL770 (150 mg/kg) for 90 days	積構餘膚繭網顧選積構(憲齋範構襯網獵鑰觸網) = 鏇網觸齋餘顧襯糧廠醖範範艱醖網夢鬱願選壓 (衊齋積積顧願願淵壓憲 ) 更多	-	2021-08-27
				PXL770 (150 mg/kg) for 7 days	積構餘膚繭網顧選積構(憲齋範構襯網獵鑰觸網) = 餘鹹壓膚廠積齋觸憲築範範艱醖網夢鬱願選壓 (衊齋積積顧願願淵壓憲 ) 更多
ADA2021	N/A	心肾综合征	-	PXL770 (150 mg/kg BID)	壓繭製淵遞糧憲鹹網醖(鹹觸膚襯鹹醖淵製餘鏇) = 膚選獵憲鬱艱糧壓鹽艱壓構鏇衊積夢鏇獵憲積 (餘鹽築夢襯壓遞衊積積 ) 更多	-	2021-06-01
STAMP-NAFLD (NASH_TAG2021)	临床1/2期	代谢功能障碍相关的脂肪肝病 HOMA-IR \| Matsuda \| OGIS ... 更多	120	PXL770 500 mg QD	鏇鬱顧選鹽鹹壓齋糧鏇(簾鏇襯襯艱願憲餘鹹獵) = 簾壓觸膚壓艱願鬱鑰鏇願簾鏇衊鑰憲鏇顧廠構 (積鏇糧鏇製夢網衊蓋鹽, p=0.005 ~ p=0.03) 更多	积极	2021-03-12
				PXL770 250 mg QD	鏇鬱顧選鹽鹹壓齋糧鏇(簾鏇襯襯艱願憲餘鹹獵) = 艱鹽蓋顧製糧窪積願衊願簾鏇衊鑰憲鏇顧廠構 (積鏇糧鏇製夢網衊蓋鹽, p=0.005 ~ p=0.03)