GlobeNewswire

Novelion Therapeutics Announces Presentation of Positive Metreleptin Data at American Diabetes Association Scientific Sessions

Del

Data Show Leptin Replacement Therapy Sustainably Decreased Weight Over Time in Patients with Low Baseline Leptin Levels

Company plans to initiate Phase 2 proof of concept study in hypoleptinemic metabolic disorder (HMD) by year-end

VANCOUVER, British Columbia, June 25, 2018 (GLOBE NEWSWIRE) -- Novelion Therapeutics Inc. (NASDAQ:NVLN), a biopharmaceutical company dedicated to developing and commercializing therapies for individuals living with rare diseases, today announced that clinical data from a metreleptin study assessing weight loss in overweight and obese adults with low leptin levels will be featured in a poster presentation at the American Diabetes Association's (ADA) 78th Scientific Sessions, being held June 22-26, 2018 in Orlando.  

The study, titled "Efficacy of Metreleptin for Weight Loss in Overweight and Obese Adults With Low Leptin Levels," was conducted in adults with low baseline leptin, defined as <16 ng/mL in females and <5 ng/mL in males, and Body Mass Index (BMI) levels between 27.5 and 38.0 kg/m2. The study assessed weight levels in these patients (n=267) following once-daily subcutaneous doses of 10 mg metreleptin, 20 mg metreleptin, or placebo over 24 weeks.

Patients with low leptin who received the 10 mg dose (n=74) or 20 mg dose (n=72) of metreleptin showed greater decreases in weight from baseline over the 24-week period compared to patients who received placebo (n=111). In addition, patients treated with the 20 mg dose displayed statistically significant weight loss by weeks 8-10, regardless of whether they had the highest or the lowest baseline levels of leptin. Notably, weight loss was maintained across dose levels for the entire six-month duration of the study, and patients with the lowest leptin levels benefitted most from metreleptin treatment.

Metreleptin was generally well-tolerated at both doses. The most common adverse events (AEs) were injection-site reactions, headache, fatigue, gastrointestinal events, and upper respiratory tract infection. Most AEs were mild to moderate in severity.

"We are very pleased with the data indicating metreleptin's activity in a population of overweight and obese adults with low baseline leptin levels, who are in need of options to help them lose weight and control the metabolic complications associated with their disease," said Dr. Murray Stewart, Executive Vice President, Head of Research and Development for Novelion. "This is encouraging because it suggests that leptin replacement shows promise in the treatment of overweight and obese adult patients suffering from hypoleptinemic metabolic disorders who are characterized by very low leptin levels. Based on this data, we look forward to initiating a Phase 2 proof of concept study in HMD before year-end."

The study was conducted by Alex DePaoli, M.D., Alison Long, M.D., Ph.D., Gregory Fine, M.S., Murray Stewart, M.D., and Sir Stephen O'Rahilly FRS FRCP.

Presentation Details

Title: Efficacy of Metreleptin for Weight Loss in Overweight and Obese Adults With Low Leptin Levels
Presenter:
 Dr. Alex M. DePaoli, Sansum Diabetes Research Institute
Abstract Number: 296-LB
Date: 
Monday, June 25, 2018 at 12:00 PM 

About Hypoleptinemic Metabolic Disorder (HMD)

HMD is a spectrum of metabolic sequelae secondary to underlying leptin deficiency.  These patients differ from epidemic "lifestyle" diseases such as common obesity, type 2 diabetes mellitus/insulin resistance and dyslipidemia, in that low leptin may be the driver of the metabolic dysfunction. Metreleptin is not intended to treat common obesity or adult onset diabetes; however, it may be a potential treatment option in a small segment of this population, specifically those patients with very low leptin levels.

Metreleptin is not currently approved for use in HMD. Metreleptin is only approved by the U.S. Food and Drug Administration as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. In addition, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorization, under exceptional circumstances, for metreleptin as an adjunct to diet, as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients with confirmed congenital generalized LD or acquired generalized LD in adults and children 2 years of age and above; or with confirmed familial partial LD or acquired partial LD, in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

IMPORTANT SAFETY INFORMATION

Highlights of Safety Information from U.S. Prescribing Information for MYALEPT (metreleptin U.S. brand name)

WARNING:  RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA

See  full prescribing information  for complete boxed warning.

Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during MYALEPT treatment.

T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of MYALEPT treatment in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.

MYALEPT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYALEPT REMS PROGRAM.

CONTRAINDICATIONS

MYALEPT is contraindicated in general obesity not associated with congenital leptin deficiency and in patients with hypersensitivity to metreleptin.

WARNINGS AND PRECAUTIONS

Anti-metreleptin antibodies with neutralizing activity: Could inhibit endogenous leptin action and/or result in loss of MYALEPT efficacy.  Test for neutralizing antibodies in patients with severe infections or loss of efficacy during MYALEPT treatment.

T-cell lymphoma:  Carefully consider benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.

Hypoglycemia:  A dose adjustment, including possible large reductions, of insulin or insulin secretagogue may be necessary. Closely monitor blood glucose in patients on concomitant insulin, or insulin secretagogue.

Autoimmunity:  Autoimmune disorder progression has been observed in patients treated with MYALEPT.  Carefully consider benefits and risks of MYLEPT treatment in patients with autoimmune disease.

Hypersensitivity reactions (e.g., anaphylaxis, urticaria or generalized rash) have been reported.  Patients should promptly seek medical advice about discontinuation of MYALEPT if a hypersensitivity reaction occurs.

Benzyl Alcohol Toxicity:  Preservative-free Water for Injection is recommended for use in neonates and infants.

ADVERSE REACTIONS

Most common adverse reactions (> / = 10%) in clinical trials were headache, hypoglycemia, decreased weight, and abdominal pain.

USE IN SPECIAL POPULATIONS

MYALEPT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  No adequate and well-controlled studies have been conducted with metreleptin in pregnant women. Nursing Mothers should discontinue drug or nursing.

For additional information, please see the  U.S. Prescribing Information  including Box Warning for MYALEPT.

About Novelion Therapeutics

Novelion Therapeutics is a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases. Novelion has a rare disease product portfolio through its subsidiary, Aegerion Pharmaceuticals, Inc. The Company seeks to advance its portfolio of rare disease therapies by investing in science and clinical development.

Forward Looking Statements

Certain statements in this press release constitute "forward-looking statements" of Novelion within the meaning of applicable laws and regulations and constitute "forward-looking information" within the meaning of applicable securities laws. Any statements contained herein which do not describe historical facts, including statements regarding our plans to initiate a Phase 2 proof of concept study in HMD and our expectations and beliefs about leptin replacement showing promise in the treatment of overweight and obese adult patients suffering from hypoleptinemic metabolic disorders who are characterized by very low leptin levels, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, that clinical data, such as the data included in the poster presentation, does not mean that metreleptin will have success in the planned Phase 2 proof of concept study in HMD or subsequent, later stage clinical trials and those risks identified in our filings with the U.S. Securities and Exchange Commission (the "SEC"), including under the heading "Risk Factors" in our Annual Report on Form 10-K filed on March 16, 2018, and subsequent filings, with the SEC, available on the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect our results of operations and cash flows, which would, in turn, have a significant and adverse impact on our stock price. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, we undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. 

Investors and others should note that we communicate with our investors and the public using our company website, www.novelion.com, including, but not limited to, company disclosures, investor presentations and FAQs, SEC filings, press releases, public conference call transcripts and webcast transcripts. The information that we post on this website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

CONTACT:

Amanda Murphy, Director, Investor Relations & Corporate Communications
Novelion Therapeutics
857-242-5024
amanda.murphy@novelion.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novelion Therapeutics Inc. via Globenewswire

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Bio-Fence announces a breakthrough in Food Safety18.1.2019 08:11Pressemelding

The company have successfully completed a field trial of its new anti-microbial coating technology. The trials demonstrated a significant reduction in bacterial contamination during sensitive food production processes ASHDOD, Israel, Jan. 18, 2019 (GLOBE NEWSWIRE) -- Bio-Fence innovating coating technology announced today the successful completion of an intensive field trial on its innovative anti-microbial technology Pentagon. The trial was held in "Milouoff" (http://www.milouoff.co.il), one of the largest Ready to Eat poultry production sites in Israel and demonstrated superior results for Bio-Fence technology compared to alternatives. According to Mrs. Shiran Davidi, QA manager at Milouoff: “Bio-Fence technology seems to have clear benefits over existing antimicrobial solution. It is safe, highly potent and rechargeable.” The trial involved monitoring the performance of an epoxy floor coated with Bio-Fence anti-microbial technology compared to either commercial Silver Ion coating an

ERYTECH Presents TRYbeCA-1 Trial-in-Progress Poster at the 2019 ASCO GI Annual Meeting18.1.2019 07:00Pressemelding

LYON, France and CAMBRIDGE, Mass., Jan. 18, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced that a poster entitled “TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)” will be presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in San Francisco. The poster (Abstract # TPS471) will be available at www.erytech.com after presentation at the conference. In September 2018, the TRYbeCA-1 trial was initiated. The Trial-in-Progress poster will provide an update on the study progress with investigators sites that have been initiated in multiple countries and actively recruiting patients. The trial is planned to enroll approximately 500 patients with

Fossil Group Enters Agreement To Sell Select Smartwatch Technology To Google17.1.2019 18:30Pressemelding

Transaction Unlocks Growth Opportunities for Fossil Group’s Wearables Business RICHARDSON, Texas, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Today, Fossil Group (NASDAQ:FOSL) announced its plan to sell to Google for $40 million intellectual property (IP) related to a smartwatch technology currently under development by Fossil Group. As part of the transaction, a portion of Fossil Group’s research and development (R&D) team currently supporting the transferring IP will join Google. Fossil Group retains more than 200 R&D team members to focus on innovation and product development. The transaction showcases Fossil Group and Google’s shared investment in the wearables industry. In recent years, smartwatches have become Fossil Group’s fastest growing category. The company successfully developed and launched smartwatches across 14 of its owned and licensed brands. “Fossil Group has experienced significant success in its wearables business by focusing on product design and development informed by our

Calgon Carbon Corporation Announces Global Price Increase17.1.2019 17:16Pressemelding

Pittsburgh, PA, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Calgon Carbon Corporation today announced a global price increase, effective February 1, 2019, where contracts permit, on all activated carbon products and related equipment due to a continued escalation in raw material costs and transportation expenses. The increase is expected to range between 10-15%, depending on the specific product, raw material type, services provided, and global market dynamics. The primary raw materials used for producing activated carbon are coal, coconut shell, and wood, each of which has gone up in price. Additionally, costs associated with both operating manufacturing facilities and transporting materials have also escalated. “Calgon Carbon’s raw material costs have increased significantly. Despite every effort to offset these increases through continuous improvements, the recent rise in raw material costs has exceeded our efforts,” said Jim Coccagno, Chief Commercial Officer for Calgon Carbon Corporation. “

Taconic Biosciences’ Animals Complete Most Recent Mission to the International Space Station17.1.2019 15:29Pressemelding

RENSSELAER, N.Y., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces the completion of a recent mission to the International Space Station. This project represents a collaboration between the International Space Station (ISS) National Lab, National Aeronautics and Space Administration (NASA), Bioserve Space Technologies with support from the Leidos Corporation, and Taconic. Taconic has participated in several spaceflight missions with NASA since 1985. Most recently, as part of the science and research investigation payloads supported by the SpaceX Commercial Resupply Services missions, Taconic prepared mice to live aboard the International Space Station for extended periods. Previous spaceflight studies demonstrated that mice undergo rapid loss of muscle and bone mass, resembling accelerated aging. Therefore, mice exposed to microgravity via spaceflight are a valuable model to understand and devel

MPP Global Bridges the Innovation Gap by Centralising Physical and Digital Subscriber Management and Billing in a Single Cloud Platform17.1.2019 12:29Pressemelding

WARRINGTON, UK, Jan. 17, 2019 (GLOBE NEWSWIRE) -- MPP Global, the technology company that delivers eSuite, the world’s smartest subscriber management & billing platform, announces the launch of pivotal new functionality which enables media organisations to seamlessly create and manage the sale of physical subscriptions. This positions eSuite as the complete physical and digital subscription management solution. The development of this industry-first functionality was borne out of the common challenge for publishers when managing multiple systems for deploying bundled print and digital subscriptions. This is inflexible for publishers and limits choice for their customers, restricting the ability to seamlessly create and offer digital and print subscription bundles. Despite increased consumer uptake of digital subscriptions, print still accounts for almost 90% of circulation revenues globally. To drive reader revenues successfully, publishers require functionality to execute complementar