Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Euronext Paris  >  Poxel    POXEL   FR0012432516

POXEL

(POXEL)
  Report  
Delayed Quote. Delayed Euronext Paris - 11/15 11:35:26 am
7.55 EUR   +1.07%
10/07POXEL : 3rd quarter earnings
CO
09/18POXEL : Initiates Phase 1b Multiple Ascending Dose Trial for NASH Drug Candidate, PXL065
AQ
08/26POXEL : Half-year results
CO
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector newsAnalyst Recommendations

Poxel : Announces Favorable Results for PXL065 Phase 1a Single Ascending Dose Trial

share with twitter share with LinkedIn share with facebook
share via e-mail
0
04/08/2019 | 12:13pm EST
  • PXL065 observed to have a favorable safety, tolerability and pharmacokinetic profile in the Phase 1a trial
  • PXL065 is advancing into a Phase 1b multiple ascending dose trial to support a pivotal Phase 2 trial in NASH

LYON, France--(BUSINESS WIRE)--

POXEL SA (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 favorable results from the Phase 1a two-part study that included three single doses of PXL065 and a single dose of Actos®* (pioglitazone). PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, is a mitochondrial pyruvate carrier (MPC) inhibitor being developed for the treatment of NASH.

'We are pleased with the outcome of the PXL065 Phase 1a study which supports the preclinical studies and modelling showing 15 mg of PXL065 has the potential to provide an improved therapeutic profile over 45 mg Actos®,' said Thomas Kuhn, CEO of Poxel. 'We are planning to initiate the Phase 1b multiple ascending dose (MAD) trial in healthy subjects during the second quarter of 2019 with completion expected in the third quarter. This study will be important in the development plan of PXL065, and the potential use of the 505(b)(2) regulatory pathway could provide an expedited development approach to a registration program.'

The Phase 1a study evaluated the safety, tolerability and pharmacokinetics (PK) of several doses of PXL065 compared to 45 mg Actos® in a total of 24 healthy subjects. In this study, PXL065 was observed to show a favorable safety and tolerability profile with no serious adverse events. PK assessment showed that PXL065 plasma exposure (Cmax and AUC) increased in a dose-proportional manner up to 22.5 mg following oral administration with moderate inter-individual variability. Furthermore, stabilization of R-pioglitazone with deuterium was confirmed at all doses tested.

'As a hepatologist, I participated in early Phase 2 clinical trials with pioglitazone in biopsy-proven NASH patients. Although pioglitazone has achieved the most compelling treatment effects to date for resolution of NASH without worsening of fibrosis, it is only prescribed by a small percentage of physicians, around 14%1, for biopsy-proven NASH patients. The primary reason for this is pioglitazone's side effect of weight gain,' said Stephen A. Harrison, MD, Visiting Professor of Hepatology, Radcliffe Department of Medicine, University of Oxford, UK. 'I am excited about the potential for an improved therapeutic profile for PXL065 for the treatment of NASH, particularly the opportunity for reduced weight gain.'

Based on the favorable results in the Phase 1a study, the Company is preparing to initiate a Phase 1b MAD trial. This double-blind, randomized, placebo-controlled study will assess the safety, tolerability and PK in healthy subjects after 7 days of dosing with several doses of PXL065 versus 45 mg Actos®.

During the remainder of 2019, preparation for the pivotal Phase 2 program of PXL065 in biopsy-proven NASH patients will also include a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration to discuss the NASH development strategy.

About NASH

Non-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.

About PXL065

PXL065, formerly DRX-065, is deuterium-stabilized R-pioglitazone. Pioglitazone is the most extensively studied drug for NASH and has demonstrated 'resolution of NASH without worsening of fibrosis' in a Phase 4 trial2. 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).3 Pioglitazone's use for NASH, however, has been limited due to the PPARγ-related side effects, which include weight gain, bone fractures and fluid retention.

Pioglitazone is a 1:1 mixture of two mirror-image compounds (R and S-stereoisomers) that interconvert in vivo. Using deuterium, we stabilized each stereoisomer and characterized their dramatically different pharmacological properties. In in vitro studies, PXL065 has been shown to target MPC as an inhibitor. In preclinical models, PXL065 exhibits the anti-inflammatory activity and NASH efficacy associated with pioglitazone with little or no weight gain or fluid retention, side effects which are associated with the S-stereoisomer. Based upon preclinical and Phase 1 results to date, PXL065 is expected to exhibit a better therapeutic profile than pioglitazone for NASH.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH). We have successfully completed the Phase 2 clinical program for our first-in-class lead product, Imeglimin, which targets mitochondrial dysfunction, in the U.S., Europe and Japan. Together, with our partner Sumitomo Dainippon Pharma, we are conducting the Phase 3 Trials of IMeglimin for Efficacy and Safety (TIMES) program for the treatment of type 2 diabetes in Japan. Our partner Roivant Sciences is responsible for Imeglimin's development and commercialization in countries outside of Poxel's partnership with Sumitomo Dainippon Pharma, including the U.S. and Europe. PXL770, a first in class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is in a Phase 2a proof-of-concept program for the treatment of NASH. PXL770 could also have the potential to treat additional metabolic diseases. PXL065 (deuterium-stabilized R-pioglitazone), a mitochondrial pyruvate carrier (MPC) inhibitor, is in Phase 1 and being developed for the treatment of NASH. Poxel also has additional earlier-stage programs, including deuterated drug candidates for metabolic, specialty and rare diseases. We intend to generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, www.poxelpharma.com)

*Actos is the branded version of pioglitazone and a registered trademark of Takeda Chemical Industries, Ltd.

1. Therap Adv Gastroenterol. 2016, 9(1), 4-12
2. Cusi, et al., Ann Intern Med. 2016, 165(5), 305-315
3. J Hepatol. 2016, 64(6),1388-402; Hepatology 2018, 67, 328-357

View source version on businesswire.com: https://www.businesswire.com/news/home/20190408005351/en/

Poxel SA
Jonae R. Barnes
Senior Vice President, Investor Relations and Public Relations
jonae.barnes@poxelpharma.com
+1 (617) 818-2985

Investor relations / Media - EU/US
Trophic Communications
Stephanie May or Joanne Tudorica
may@trophic.eu
+49 89 238 877 34 or +49 171 185 56 82

Investor relations / Media - France
NewCap
Alexia Faure/Nicolas Merigeau
poxel@newcap.eu
+33 1 44 71 94 94

Source: Poxel SA

Released April 8, 2019

Disclaimer

Poxel SA published this content on 08 April 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 08 April 2019 16:12:01 UTC

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on POXEL
10/07POXEL : 3rd quarter earnings
CO
09/18POXEL : Initiates Phase 1b Multiple Ascending Dose Trial for NASH Drug Candidate..
AQ
08/26POXEL : Half-year results
CO
08/06POXEL : Initiates Pharmacokinetic Pharmacodynamic Study as part of the Phase 2a ..
AQ
07/15GLOBAL MARKETS LIVE : Facebook, Gilead, AB Inbev, Boeing…
07/15POXEL : 2nd quarter earnings
CO
06/30POXEL : Half-year report
CO
06/26Poxel and Sumitomo Dainippon Pharma Announce Second Positive Top-Line Results..
AQ
06/25POXEL : and Sumitomo Dainippon Pharma Announce Second Positive Top-Line Results ..
PU
04/10Poxel and Sumitomo Dainippon Pharma Announce Positive Top-Line Results for Im..
AQ
More news
Financials (EUR)
Sales 2019 35,0 M
EBIT 2019 -19,8 M
Net income 2019 -20,0 M
Finance 2019 25,3 M
Yield 2019 -
P/E ratio 2019 -9,64x
P/E ratio 2020 -5,41x
EV / Sales2019 4,86x
EV / Sales2020 7,63x
Capitalization 195 M
Chart POXEL
Duration : Period :
Poxel Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends POXEL
Short TermMid-TermLong Term
TrendsBearishBullishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 3
Average target price 15,13  €
Last Close Price 7,55  €
Spread / Highest target 125%
Spread / Average Target 100%
Spread / Lowest Target 81,5%
EPS Revisions
Managers
NameTitle
Thomas Kuhn Chief Executive Officer & Director
Pierre Legault Chairman
Anne Renevot Chief Financial Officer
Sophie Hallakou-Bozec Senior Vice Chairman-Research & Development
Christophe Arbet-Engels Chief Medical Officer & EVP-Medical Affairs
Sector and Competitors
1st jan.Capitalization (M$)
POXEL48.33%216
GILEAD SCIENCES4.03%82 323
VERTEX PHARMACEUTICALS26.61%53 950
REGENERON PHARMACEUTICALS-7.67%37 702
WUXI APPTEC CO., LTD.81.65%22 459
GENMAB39.63%14 493