Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

fiercepharma | June 11, 2019

One brand-new FDA approval and one trial win for its blood cancer drug Gazyva added up to a double dose of good news for Roche Monday. The Swiss drugmaker snapped up a combo approval for lymphoma drug Polivy, then touted Gazyva trial results in a completely different field: lupus nephritis, a potentially fatal complication of the autoimmune disease systemic lupus erythematosus. In a phase 2 study, adding Gazyva to standard lupus nephritis treatment beat that standard of care alone alone at delivering complete renal responses at one year. The drug also hit key secondary goals. There are no drugs specifically approved to treat lupus nephritis. The standard of care used in the trial combined one of two immunosuppressant drugs approved for organ transplant patients—CellCept or Myfortic—with corticosteroids and placebo. Roche plans to present the full data at an upcoming meeting.

Spotlight

Transitioning patients between outpatient, inpatient, post-acute and home settings can be a major challenge for hospitals. For organizations participating in value-based reimbursement models, it can also be costly. This case study examines how Holyoke (Mass.) Medical Center redesigned its care management process to break down communication siloes across the care continuum and improve patient care. After six months, the efforts yielded measurable results, including improved patient experience scores and reduced readmissions based on an analysis by Press Ganey.

Spotlight

Transitioning patients between outpatient, inpatient, post-acute and home settings can be a major challenge for hospitals. For organizations participating in value-based reimbursement models, it can also be costly. This case study examines how Holyoke (Mass.) Medical Center redesigned its care management process to break down communication siloes across the care continuum and improve patient care. After six months, the efforts yielded measurable results, including improved patient experience scores and reduced readmissions based on an analysis by Press Ganey.

Related News

BUSINESS INSIGHTS

Septerna Strengthens Leadership Team to Advance Novel Small Molecule GPCR Medicines

Septerna | July 29, 2022

Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases. We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.” “Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.” Ms. Bhatt Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University. Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst. About GPCRs G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged. About Septerna Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.

Read More

PHARMA TECH

Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections

Armata Pharmaceuticals, Inc | August 02, 2022

Armata Pharmaceuticals, Inc. a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration has cleared Armata's Investigational New Drug application for AP-SA02 in prosthetic joint infection. The company is initiating start-up activities for the Phase 1b/2a trial that will explore the safety, tolerability, and pharmacokinetics of intravenous and intra-articular doses of AP-SA02 as an adjunct to standard of care antibiotics in subjects with PJI. "Prosthetic joint infection is one of the most serious complications of prosthetic joint implantation. Staphylococcus aureus is a dominant pathogen that drives the need for surgical intervention and prolonged courses of antibiotic therapy. The ability of S. aureus to create biofilms that are refractory to standard of care antibiotics highlights the need for a novel therapy. Phage therapy may fill this need for PJI patients as phage have demonstrated the ability to disrupt biofilm and work synergistically with antibiotics." Dr. Mina Pastagia, Armata's Senior Vice President of Clinical Development "Armata is excited to explore AP-PA02 in patients who suffer from complicated joint infections that don't respond adequately to standard of care antibiotics. PJI is a logical extension of our diSArm trial which is targeting complicated S. aureus bacteremia," said Brian Varnum, Chief Executive Officer of Armata. "With this IND approval, Armata now has four active clinical programs. Today marks an important development milestone for Armata and its investors who set a course three years ago to transform phage therapy from a promising new technology to one that is explored in rigorous clinical settings." In addition to evaluating AP-SA02 in PJI and bacteremia due to S. aureus, Armata has advanced AP-PA02 into the Phase 2a component of the SWARM-P.a. study which targets chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF). In February, the company gained IND clearance for AP-PA02 in a second indication, non-cystic fibrosis bronchiectasis targeting patients with chronic P. aeruginosa infections in a Phase 2 trial. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.

Read More

PHARMACY MARKET

Acorda Therapeutics Enters into License Agreement with Asieris Pharmaceuticals

Asieris | August 30, 2022

Acorda Therapeutics, Inc. announced that it has entered into a license agreement relating to its preclinical asset, Nepicastat, with Asieris Pharmaceuticals, a biotechnology company headquartered in China. Under the terms of the agreement, Acorda will receive an upfront payment of $500,000, and up to an additional $7 million based on the achievement of regulatory milestones. Acorda will also receive a royalty on future net sales. Nepicastat is a small molecule drug and the license agreement provides for its development for all non-psychiatric indications and therapeutic uses. The asset has been held by Acorda’s U.S. subsidiary, Biotie Therapies, Inc. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

Read More