- \n
- Imeglimin Japanese New Drug Application (J-NDA) under review following submission by Poxel\u2019s partner, Sumitomo Dainippon Pharma,with product launch anticipated in 20211<\/sup><\/b><\/li>\n
- Successful completion of PXL770 Phase 2a STAMP-NAFLD trial in NASH with new data demonstrating greater response in high-risk patients with co-existing type 2 diabetes (T2DM), estimated to affect about 50% of NASH patients2<\/sup><\/b><\/li>\n
- 52-week Phase 2b trial evaluating up to two doses of PXL770 in approximately 100 patients per study arm with biopsy-proven NASH and pre-diabetes or T2DM expected to commence in H2 2021<\/b><\/li>\n
- PXL065 Phase 2 study underway with topline data readout expected mid-2022<\/b><\/li>\n
- Financial position strengthened through capital increase of EUR 17.7 million in May 2020 and EUR 6 million in October 2020 in non-dilutive funding in the form of a French Government Guarantee Loan (Pr\u00eats Garantis par l\u2019Etat or PGE) in the context of the COVID-19 pandemic. This loan has an initial term of one year, with a five-year extension option. The Company already decided to activate the extension option<\/b><\/li>\n
- As of December 31, 2020, cash and cash equivalents were EUR 40.2 million (USD 49.4 million)<\/b><\/li>\n<\/ul>\n
LYON, France–(BUSINESS WIRE<\/a>)–POXEL SA<\/a> (Euronext: POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced its results for the year ended December 31, 2020 and provided a corporate update.\n<\/p>\n
\n\u201cLooking back, 2020 was a strong year for Poxel in which we achieved critical clinical milestones to advance our key programs PXL770 and PXL065 into late-stage development with promising data readouts, and further asserted ourselves as an industry leader in metabolic diseases,\u201d commented Thomas Kuhn, CEO of Poxel. \u201cFurther, with the submission of the J-NDA for Imeglimin for the treatment of T2DM we are in a strong position and moving toward a potential market launch in Japan in 20212<\/sup>. We were also able to present additional results from our Phase 3 TIMES 2 and TIMES 3 clinical trials at the 56th<\/sup> EASD Annual Meeting, highlighting Imeglimin\u2019s unique position and strong therapeutic profile both as a monotherapy and in combination with standard of care available in Japan, including DPPIV inhibitors, a notable feature considering that this drug class is the market leader in Japan and is prescribed to approximately 80% of treated T2DM patients3<\/sup>. In parallel with this, we are pursuing the development of our two NASH candidates, PXL770 and PXL065. Results from our Phase 2a trial with PXL770 showed consistently greater response in patients with coexisting T2DM, highlighting its potential in this high-risk and underserved patient population. Despite the pandemic, recruitment for the PXL065 Phase 2 trial has been progressing as planned. Taken together, all of these achievements show the tremendous potential of the pipeline we are proud to build upon and the future we are headed toward as we expand our AMPK activation and TZD platforms.\u201d\n<\/p>\n
\n\u201c2021 will be a very special year for Poxel. We have built the Company to bring novel treatments to patients with chronic metabolic disorders and this vision will become a reality once Imeglimin is approved in Japan, anticipated this year. We will also complete PXL065 Phase 2 recruitment and are planning to initiate a Phase 2b study for PXL770 in biopsy-proven NASH patients. We remain committed to advancing our programs alone and together with partners in an effort to bring tangible solutions to patients living with metabolic diseases,\u201d continued Mr. Kuhn.\n<\/p>\n
Clinical Development Updates<\/b><\/p>\n
Imeglimin (Type 2 Diabetes)<\/b><\/p>\n
- \n
- \nIn November 2020, Poxel announced that, for strategic reasons, its partner Metavant would not be moving forward with the Imeglimin development program. This decision was not based on any efficacy, safety or other data generated through the partnership. Poxel regained all rights to Imeglimin at the end of January 2021.\n<\/li>\n
- \nIn September 2020, Poxel presented Imeglimin Phase 3 TIMES results at the 56th<\/sup> European Association for the Study of Diabetes Annual Meeting. Phase 3 TIMES 2 and TIMES 3 trial results demonstrated Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.\n<\/li>\n
- \nIn July 2020, Poxel announced the submission of the Imeglimin J-NDA for the treatment of T2DM by its partner, Sumitomo Dainippon Pharma. The submission triggered a JPY500 million (EUR 4.1 million, USD 4.7 million)4<\/sup> development milestone payment to Poxel with the potential for a JPY 1.75 billion (approximately EUR 13.8 million, USD 16.9 million)5<\/sup> milestone payment upon product approval. The target product launch date is anticipated in 20216 <\/sup>which will trigger the potential for sales-based payments and escalating double-digit royalties on product sales.\n<\/li>\n
- \nIn April 2020, Poxel announced the publication of Imeglimin clinical study results in Clinical Pharmacokinetics<\/i>. The two clinical studies evaluated the potential for drug-drug interactions of Imeglimin with two widely prescribed medications, metformin or sitagliptin. Imeglimin was observed to be safe and well-tolerated in both studies.\n<\/li>\n<\/ul>\n
PXL770 (NASH)<\/b><\/p>\n
- \n
- \nIn December 2020, Poxel announced additional positive Phase 2a results showing greater response in high-risk patients with coexisting T2DM, and a Phase 2b Plan for PXL770, an oral first-in-class AMPK activator, in NASH7<\/sup>.\n<\/li>\n
- \nIn November 2020, Poxel presented new preclinical data for PXL770 at the AASLD The Liver Meeting\u00ae<\/sup> 2020. PXL770 revealed the potential for direct effects on key components of NASH as both a mono- and combination therapy producing anti-inflammatory effects in mouse liver and adipose tissue and in human immune cells as well as specific biomarkers related to improvements involving mitochondria in mouse liver.\n<\/li>\n
- \nIn October 2020, Poxel announced positive results from its Phase 2a NASH trial with PXL770. The trial met its primary efficacy endpoint and was observed to be safe and well tolerated.\n<\/li>\n
- \nIn September 2020, Poxel presented PXL770 preclinical cardio-renal results at the 56th<\/sup> European Association for the Study of Diabetes Annual Meeting. PXL770 was observed to improve renal and cardiac disease in a preclinical model which revealed its utility for not only NASH co-morbidities but also additional indications driven by metabolic dysfunction.\n<\/li>\n
- \nIn June 2020, Poxel announced positive pharmacokinetic (PK) \/ pharmacodynamic (PD) study results for PXL770.\n<\/li>\n<\/ul>\n
PXL065 (NASH)<\/b><\/p>\n
- \n
- \nPXL065 is currently being evaluated in DESTINY-1, a Phase 2 study in biopsy-proven NASH patients, which seeks to identify the optimal dose or doses for a Phase 3 registration trial.\n<\/li>\n
- \nThe recruitment for the DESTINY-1 Phase 2 study is expected to be completed in 2021.\n<\/li>\n
- \nIn November 2020, Poxel presented Phase 1b clinical results for PXL065 at the AASLD The Liver Meeting\u00ae 2020. Analysis of results from the study predicts efficacy at 15 mg once-daily is equivalent to 45 mg Actos\u00ae8<\/sup>, with little to no PPAR\u03b3-related side effects, such as weight gain.\n<\/li>\n<\/ul>\n
Early Stage Development <\/b><\/p>\n
- \n
- \nIn November 2020, at ALD Connect, the Company presented new results in cell-based and in vivo<\/i> preclinical models of adrenoleukodystrophy. These data showed that both PXL770 and PXL065 produced significant improvements in disease-associated pathology, providing a rationale to pursue this indication with next generation molecules derived from both platforms.\n<\/li>\n
- \nThe potential of PXL770 and PXL065 with other agents in development continues to be assessed in preclinical studies. Further preclinical studies are ongoing to evaluate direct adenosine monophosphate-activated protein kinase (AMPK) activation and mitochondrial pyruvate carrier (MPC) inhibition in additional metabolic, specialty and rare diseases.\n<\/li>\n<\/ul>\n
Corporate Updates<\/b><\/p>\n
- \n
- \nIn October 2020, Poxel received EUR 6 Million in non-dilutive financing guaranteed by the French government.\n<\/li>\n
- \nIn May 2020, Poxel successfully raised EUR 17.7 million in a capital increase. The proceeds will enable the acceleration of development plans for PXL770 and PXL065 for treatment of NASH, the pursuit of development activities in other metabolic diseases and will be used for general corporate purposes.\n<\/li>\n
- \nIn January 2020, Poxel appointed David E. Moller, MD, as CSO. Dr. Moller is an industry leader in the discovery and development of new therapeutic agents, particularly in diabetes and metabolic disorders.\n<\/li>\n<\/ul>\n
Significant Events after the Period<\/b><\/p>\n
- \n
- \nIn February 2021, Poxel announced the resolution of the arbitration procedure with Merck Serono.\n<\/li>\n
- \nIn January 2021, Poxel regained Imeglimin rights from Metavant. Metavant has returned all rights to Imeglimin to Poxel in addition to all data, materials and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payments from Poxel as part of the return.\n<\/li>\n
- \nImeglimin\u2019sinnovative MOA and Phase 2b\/3 results in Japan were published in peer reviewed journals.\n<\/li>\n<\/ul>\n
\n___________________
\n
*Actos is the branded version of pioglitazone and a registered trademark of Takeda Chemical Industries, Ltd.\n<\/p>\nFinancial Statements for Full Year 2020 (IFRS Standards)<\/b><\/p>\n
Revenue<\/b><\/p>\n
\nPoxel reported revenues of EUR 6.8 million for the year ended December 31, 2020, as compared to EUR 26.6 million during the corresponding period in 2019.\n<\/p>\n
\nThe revenues for 2020 include the JPY 500 million (EUR 4.0 million) milestone payment that Poxel received from Sumitomo Dainippon Pharma for the submission of the Imeglimin J-NDA. To a lesser extent, it also includes an allocated portion of the EUR 36.0 million upfront payment received from Sumitomo Dainippon Pharma relating to the strategic corporate partnership announced on October 30, 2017, as well as the residual Imeglimin Phase 3 program costs in Japan incurred in 2020 that were re-invoiced to Sumitomo Dainippon Pharma. Both the allocated portion of the upfront payment and the re-invoiced costs of the Phase 3 T<\/b>rials of IM<\/b>eglimin for E<\/b>fficacy and S<\/b>afety (TIMES) program have been recognized based on the accounting percentage of the completion of this program, which has been fully completed, and therefore led to the decrease in revenue in 2020.\n<\/p>\n
- \nThe potential of PXL770 and PXL065 with other agents in development continues to be assessed in preclinical studies. Further preclinical studies are ongoing to evaluate direct adenosine monophosphate-activated protein kinase (AMPK) activation and mitochondrial pyruvate carrier (MPC) inhibition in additional metabolic, specialty and rare diseases.\n<\/li>\n<\/ul>\n
- \nIn November 2020, at ALD Connect, the Company presented new results in cell-based and in vivo<\/i> preclinical models of adrenoleukodystrophy. These data showed that both PXL770 and PXL065 produced significant improvements in disease-associated pathology, providing a rationale to pursue this indication with next generation molecules derived from both platforms.\n<\/li>\n
- \nIn November 2020, Poxel presented new preclinical data for PXL770 at the AASLD The Liver Meeting\u00ae<\/sup> 2020. PXL770 revealed the potential for direct effects on key components of NASH as both a mono- and combination therapy producing anti-inflammatory effects in mouse liver and adipose tissue and in human immune cells as well as specific biomarkers related to improvements involving mitochondria in mouse liver.\n<\/li>\n
- \nIn July 2020, Poxel announced the submission of the Imeglimin J-NDA for the treatment of T2DM by its partner, Sumitomo Dainippon Pharma. The submission triggered a JPY500 million (EUR 4.1 million, USD 4.7 million)4<\/sup> development milestone payment to Poxel with the potential for a JPY 1.75 billion (approximately EUR 13.8 million, USD 16.9 million)5<\/sup> milestone payment upon product approval. The target product launch date is anticipated in 20216 <\/sup>which will trigger the potential for sales-based payments and escalating double-digit royalties on product sales.\n<\/li>\n
- Successful completion of PXL770 Phase 2a STAMP-NAFLD trial in NASH with new data demonstrating greater response in high-risk patients with co-existing type 2 diabetes (T2DM), estimated to affect about 50% of NASH patients2<\/sup><\/b><\/li>\n
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