All posts in Peptide News from Biotech and Pharma

Source: http://www.businesswire.com/
Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris:ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes with innovative formulations of approved proteins, today announced topline results from a Phase 3 clinical trial of BioChaperone PDGF (BC PDGF) in the treatment of diabetic foot ulcer (DFU), which was conducted in India.

In this trial, BC PDGF did not meet the primary endpoint of a statistically significant improvement over placebo in complete wound closure after twenty weeks of treatment. There were no safety concerns attributed to BC PDGF.

“We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase 1/2 clinical results. Therefore, we have initiated a thorough review of the study to analyse the discrepancy in the data” said Gérard Soula, CEO of Adocia. “However, diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late-stage clinical trial failures. The main reason is the lack of uniformity in the standard of care of these types of wounds. In this context, we have decided to halt all development work in this indication. As announced previously, we are focusing our efforts on our portfolio of innovative injectable therapeutics for the treatment of diabetes.”

Read more: http://www.businesswire.com/news/home/20160825005863/en/Adocia-Announces-Topline-Results-Indian-Phase-3

Source: Innovative Targeting Solutions Inc. & reported by https://www.firstwordpharma.com/
SAN FRANCISCO and VANCOUVER, Aug. 23, 2016 /CNW/ - Innovative Targeting Solutions Inc. (ITS) today announced a research collaboration with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Under the agreement, facilitated by Johnson & Johnson Innovation, the collaboration will utilize Innovative Targeting Solutions' proprietary HuTARG™ research platform to discover antibody candidates useful for modulating immune responses in autoimmunity or cancer. The HuTARG™ protein engineering platform is able to engineer both T-cell receptors and fully human antibodies that bind major histocompatibility complex (MHC)/peptide complexes displaying fragments of intracellular proteins of interest.

"Conventional biologic therapies do not target intracellular proteins which make up 60-80% of a cells proteome. The ability to target MHC/peptide complexes opens up an important untapped area for targeted therapy" said Paul Kang, CSO of Innovative Targeting Solutions Inc. "We are very excited to be working with Janssen in this exciting new area which we believe has the potential to transform the industry's ability to improve human health."

Read more: https://www.firstwordpharma.com/node/1410024?tsid=28®ion_id=4

Source: http://www.businesswire.com/
MALMÖ, Sweden -(BUSINESS WIRE) - Regulatory News: Hansa Medical AB (publ) (STO:HMED) today announced that preliminary results of the Sweden based ongoing Phase II study of IdeS were presented today by Professor Gunnar Tufveson at the 26th International Congress of the Transplantation Society in Hong Kong on August 23, 2016. The results show that IdeS has enabled kidney transplantation in all 10 out of 10 included sensitized patients. The Phase II study also shows that IdeS treatment resulted in negative cross match test in all patients, none of the transplanted patients experienced delayed graft function and all 10 transplantations resulted in very good creatinine levels.

The ongoing and fully recruited Phase II study at Uppsala University Hospital and Karolinska University Hospital in Huddinge, Sweden, includes 10 patients who received a single dose of IdeS (0.25 or 0.5 mg/kg) before kidney transplantation. The study’s primary focus is to evaluate safety and tolerability of Hansa Medical’s candidate drug IdeS in sensitized kidney transplantation patients. The study is also aimed at identifying an IdeS dose that results in anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing. Patients in the study are followed for six months after transplantation to continue to evaluate drug safety and kidney function. The study is expected to be finalized in Q4 2016.

Professor Tufveson concludes in his presentation that IdeS treatment is a suitable way to achieve rapid and effective desensitization allowing transplantation in immunized patients and that a dose level of 0.25 mg/kg body weight is a suitable dose.

Read more: http://www.businesswire.com/news/home/20160822006143/en/Hansa-Medical-Top-line-results-Swedish-ongoing

Source: Versartis, Inc. & reported by http://globenewswire.com/
MENLO PARK, Calif., Aug. 22, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced the completion of enrollment in the Phase 3 VELOCITY trial of somavaratan in pediatric GHD. With 137 patients enrolled, the trial is powered at >90% to demonstrate non-inferiority of somavaratan compared to daily rhGH. Patients will be followed for the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.

“For more than three decades, recombinant human growth hormone has been effective to treat children, adolescents and adults with growth hormone deficiency, but the daily injection schedule is inconvenient and can be painful or distressing for children and their caregivers. These issues may also lead to patient non-compliance and thus, reduced efficacy,” said Alan D. Rogol, MD, PhD, an endocrinologist and Professor Emeritus at the University of Virginia School of Medicine. “Somavaratan may offer the least frequent dosing schedule with twice-monthly dosing, and with the Phase 3 VELOCITY trial now fully enrolled, it may be the first of the long-acting growth hormone preparations currently in development to become available for children with GHD.”

Read more: http://globenewswire.com/news-release/2016/08/22/865861/0/en/Versartis-Announces-Completion-of-Enrollment-in-Phase-3-VELOCITY-Trial-of-Somavaratan-in-Pediatric-GHD.html

Source: CollPlant Ltd & reported by http://www.prnewswire.com/
CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive final extended clinical trial results for Vergenix™STR for the treatment of tendinopathy. The Company anticipates receiving CE mark approval for Vergenix™STR in the third quarter of 2016.

The prospective, open label, single-arm trial was conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), and the trial's objective was to demonstrate the safety and performance of Vergenix™STR in 40 patients suffering from inflammation of the elbow tendon, commonly referred to as tennis elbow. All patients were followed for a total of six months after a single treatment. Product performance was assessed by measuring reduction in pain and recovery of motion, as reported by the specific Patient Related Tennis Elbow Evaluation questionnaire ("PRTEE").

At three months following treatment, Vergenix™STR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, Vergenix™STR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.
Read more: http://www.prnewswire.com/news-releases/collplant-reports-positive-final-extended-clinical-trial-results-with-vergenixstr-for-treatment-of-tendinopathy-590460101.html

Source: Radius Health & reported by https://globenewswire.com/
WALTHAM, Mass., Aug. 16, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and other endocrine diseases, today announced that positive results from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were published in the Journal of the American Medical Association (JAMA). This landmark trial enrolled 2,463 patients to evaluate the safety and efficacy of investigational drug abaloparatide for the treatment of postmenopausal women with osteoporosis. The ACTIVE results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (p < 0.001) and nonvertebral fractures (p = 0.049) compared to placebo. “The landmark ACTIVE trial results are important and further validate abaloparatide’s potential to consistently, substantially and rapidly reduce both new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis,” said Dr. Paul Miller, Medical Director at the Colorado Center for Bone Research and lead author of the paper. “Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for affected women by diminishing their independence and quality of life. There is a great unmet medical need for therapies which could provide more consistent potent and early benefits to patients.” Read more: https://globenewswire.com/news-release/2016/08/16/864583/0/en/JAMA-Publishes-Positive-Phase-3-Data-for-Abaloparatide-in-Postmenopausal-Women-With-Osteoporosis.html

Source: http://www.businesswire.com/
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive top-line results from the Phase 2b AURA-LV (AURA) clinical study in patients with active lupus nephritis (LN). The trial achieved its primary endpoint, demonstrating statistically significantly greater complete remission (CR) (as defined by confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg at 24 weeks and confirmed at 26 weeks) in patients treated with 23.7 mg of voclosporin twice daily (p=0.045). Both treatment arms, 23.7 mg and 35.9 mg twice daily also showed a statistically significant improvement in the rate of achieving partial remission (PR) at 24 weeks (p=0.007; p=0.024). Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5 mg/day by week 8 and 2.5 mg by week 16. No unexpected safety signals were observed and voclosporin was shown to be well tolerated.

“We are very pleased by these encouraging results and are grateful to those that participated in our clinical trials,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “The AURA study was conducted under rigorous and stringent criteria, enhancing our confidence in voclosporin’s potential ability to provide a substantial improvement over the currently accepted standard of care, especially given that study participants had such active disease and were exposed to such a low corticosteroid load. We continue to work diligently towards our goal of improving long-term outcomes for these patients.”

Read more: http://www.businesswire.com/news/home/20160815005340/en/Aurinia-Pharmaceuticals-Announces-Voclosporin-Meets-Primary-Endpoint

Source: Ascendis Pharma & reported by http://www.prnewswire.com/
COPENHAGEN, Denmark, Aug. 11, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biopharmaceutical company that applies its innovative TransCon technology to address significant unmet medical needs, today announced the initiation of the global Phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD). The heiGHt Trial initiation follows End-of-Phase 2 discussions with the U.S. Food and Drug Administration (FDA), as well as various discussions with regulatory agencies worldwide.

"The Phase 3 heiGHt Trial initiation marks a major milestone for Ascendis and our TransCon Growth Hormone program as we move into the next stage of development," said Jonathan A. Leff, M.D., Senior Vice President and Chief Medical Officer at Ascendis. "This pivotal trial mirrors the design of our Phase 2 study in pediatric GHD that demonstrated comparable safety, efficacy, and tolerability of once-weekly TransCon Growth Hormone to a daily growth hormone therapy. This global trial is designed to support planned regulatory applications worldwide, including in the United States and Europe."
Dr. Leff continued, "The Phase 2 data for our once-weekly sustained-release TransCon Growth Hormone demonstrated the strong efficacy and favorable safety, tolerability, and convenience profile of our product candidate. As the only long-acting growth hormone that provides the same mode of action as daily growth hormone, we believe TransCon Growth Hormone can become a best-in-class option for physicians and patients to address the ongoing unmet need for an effective and convenient long-acting growth hormone therapy."
Read more: http://www.prnewswire.com/news-releases/ascendis-pharma-as-initiates-phase-3-registration-trial-for-transcon-growth-hormone-in-children-with-growth-hormone-deficiency-300312262.html