News Column

Regeneron, Sanofi Offer Positive Results from Phase 2b of Dupilum; Celgene's Drug OTEZLA Fails Phase III Trial Endpoint

July 23, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 9, 2014.

{nfg}Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
and Sanofi(EURONEXT: SAN and NYSE: SNY) announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema. All doses of dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo. In addition, the companies also announced that four earlier clinical studies of dupilumab in moderate-to-severe atopic dermatitis were published today in the New England Journal of Medicine (NEJM). Dupilumab is an investigational monoclonal antibody that blocks signaling of IL-4 and IL-13, two cytokines that play a key role in the pathogenesis of moderate-to-severe atopic dermatitis.



"These clinical data, coupled with our phase 2a results in asthma last year, support the growing scientific evidence that the IL-4/IL-13 pathway may be a fundamental driver in allergic diseases," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Blocking IL-4/IL-13 signaling may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis, where we have ongoing clinical programs."



In the Phase 2b trial, all five subcutaneous doses of dupilumab showed a dose-dependent improvement in the primary endpoint, the mean percent change in EASI score from baseline to week 16. The improvements in EASI score ranged from a high of 74 percent for patients in the highest dose group, who received 300 milligrams (mg) weekly, to a low of 45 percent in patients who received the lowest dose of 100 mg monthly, compared to 18 percent for patients in the placebo group (p


The most common adverse event (AE) in the Phase 2b study was nasopharyngitis, which was balanced across dupilumab treatment groups (18.5 to 23 percent) compared to placebo (21 percent). Injection site reactions were more frequent in the dupilumab group (5 to 9.5 percent) compared to placebo (3 percent), as was headache (12 to 15 percent) compared to placebo (8 percent).



Dupilumab-treated patients showed highly statistically significant and dose-dependent improvements in additional key efficacy measures compared to placebo after 16 weeks of treatment:



12 percent to 33 percent of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator's global assessment (IGA) score of 0 or 1, compared to 2 percent with placebo. (p=0.02 to p


Dupilumab-treated patients experienced a 16.5 percent to 47 percent mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5 percent in the placebo group. (p=0.0005 to p


"Atopic dermatitis is known to have a profoundly negative effect on quality of life and people with more severe forms of this disease have limited therapeutic choices," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "These latest results are consistent with what was observed in the earlier clinical studies and add to the body of evidence that investigational dupilumab may have a role to play for patients with moderate-to-severe atopic dermatitis. We are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year."



This Phase 2b double-blind, placebo-controlled, 16-week, dose-ranging study randomized 380 patients with moderate-to-severe atopic dermatitis, who could not be adequately controlled with topical medication or for whom topical treatment was not advisable. Patients were randomized to receive one of five doses of dupilumab (300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly) or placebo. Patients in the study had approximately 50 percent of their skin affected by atopic dermatitis at baseline. Within the past year, approximately 35 percent of patients received an oral corticosteroid and approximately 20 percent received a systemic non-steroid immunosuppressant for AD. Approximately 60 percent of patients had another allergic condition, including approximately 40 percent of patients who had a history of asthma. The follow-up period of the study is ongoing and patients will be followed for 16 weeks after treatment.



The NEJM Dupilumab Moderate-to-Severe Atopic Dermatitis Publication -- The New England Journal of Medicine publication includes data from four placebo-controlled studies, which all evaluated weekly subcutaneous doses of dupilumab. This included a Phase 2a 12-week monotherapy study, a Phase 2a, four-week study of dupilumab in combination with topical glucocorticoids and two Phase 1 four-week monotherapy studies. In these studies, the most common AEs were nasopharyngitis and headache, which occurred with a higher frequency in the dupilumab group. Treatment with dupilumab, either as a monotherapy or in combination, was associated with improvement in skin lesions and substantial improvements in pruritus (itching). The full publication is available at www.nejm.org.



"The New England Journal of Medicine publication brings important attention to moderate-to-severe atopic dermatitis, a common, chronic skin condition characterized by severe itching that can have a significant negative impact on a patient's ability to lead a full and active life," said Lisa Beck, M.D., Department of Dermatology, University of Rochester Medical Center and lead author of the NEJM paper. "We are encouraged by the consistent findings across these earlier studies and look forward to further clinical investigation with dupilumab."



About the IL-4/IL-13 Pathway and Atopic Dermatitis -- Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response. Moderate-to-severe forms of atopic dermatitis can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification (skin thickening), with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead to secondary infections. Moderate-to-severe atopic dermatitis can negatively impact patients' lives and is associated with a high burden to society in terms of direct costs of medical care and prescription drugs and loss of productivity.









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Celgene's (NASDAQ: CELG)
shares slipped nearly two percent in pre-market trading after the company said its drug candidate for treating spinal disease failed to meet the primary objective of a Phase III trial.



The drug, OTEZLA, failed to offer significant improvements in patients after 16 weeks. The targeted spinal disease is ankylosing spondylitis, which causes vertebrae to fuse together, causing pain, a hunched posture and difficulty breathing.



Celgene said despite the failure, significant improvements were observed after 24 weeks in a large subset of patients with early-stage disease. Based on this, an independent committee recommended the study to continue.



Celgene traded down less than one percent shortly after Wednesday's opening bell.









Also Wednesday:







Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces the completion of two trials, the Phase II double-blind, placebo-controlled (TRIFECTA) study and the Pharmacokinetic (PK) trial.



ActiveCare, Inc. (OTCQB:ACAR)
, a leader in diabetes management and wellness services for self-insured employers nationwide, today announced significant growth in July through the acquisition of over 1,200 members diagnosed with diabetes.



BioCorRx Inc. (OTCQB: BICX),
a leader in addiction treatment and rehabilitation programs, is pleased to announce a series of transactions that strengthens the company's balance sheet and offers future, income-producing upside through the elimination of all convertible debt.



BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
, a global leader in the development and commercialization of therapies for rare genetic diseases, today announced that Jean-Jacques BienaimÉ, Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, July 30, at 4:30 p.m. ET to discuss second quarter 2014 financial results and provide a general business update.



Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, today announced that the U.S. Patent and Trademark Office (PTO) awarded the company three patents on the reprogramming of human cells into pluripotent stem cells from human blood.



China YCT International Group, Inc (OTC:CYIG)
has recently released its 2013 fiscal year financial results ended March 31, 2014 (Please note that 'CYIG' has a fiscal year starting on April 1 and ending on March 31).



Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced that it has been added to the Russell 3000® Index and Russell 2000® Index when Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes on June 27, 2014.



Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that it has established new terms under its credit facility, including an increase in the size of the facility and an extended maturity date, with its bank group led by Bank of America, N.A. and Wells Fargo Bank.



IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice, will report its financial results for the second quarter ended June 30, 2014 on Wednesday, July 23, 2014, after the market close.



Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced today that it has received approval from the Chinese Food and Drug Administration (CFDA) to market Merit's Aero® Tracheobronchial Stent System.



Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that all preparations for the commencement of its preclinical studies to determine the effectiveness of Nuvilex's pancreatic cancer treatment in slowing down the accumulation of ascites fluid have been completed.



Ocera Therapeutics (Nasdaq:OCRX)
today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering.



Protea Biosciences Group, Inc. (OTCQB:PRGB)
and InSphero AG jointly announced today that they have entered into a collaboration that will combine each company's respective 3D technology.



The Spectranetics Corporation (Nasdaq:SPNC)
today announced that its wholly-owned subsidiary, AngioScore, Inc., developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, launched its new 200 mm length AngioSculpt® PTA Scoring Balloon Catheters for the treatment of Peripheral Artery Disease (PAD) above-the-knee (ATK).



Zogenix, Inc. (Nasdaq:ZGNX)
today commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, violates Constitutional law.


For more stories covering the world of technology, please see HispanicBusiness' Tech Channel



Source: BioMed Reports


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