STALICLA Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD)
STALICLA, a Swiss Biotech company, today announced the completion of its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) on the preparation for entry of STP1 into clinical trials.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005559/en/
STALICLA at the Food and Drug Administration (FDA) to discuss its investigational precision medicine for Autism Spectrum Disorder (Photo: STALICLA)
“We are appreciative of FDA´s technical guidance and strong interest in personalized medicine approaches for patients with Autism Spectrum Disorder. STALICLA is committed to rapidly move forward with the submission of its STP1 IND. STP1 holds the potential to become the first precision medicine for a subgroup of patients with ASD, and herald a new age for this field.”
- Lynn Durham, CEO and Founder of STALICLA.
ASD is a common neurodevelopmental disorder, with high level of heterogeneity, that affects 1 in 59 8-year-old school children in the U.S. (CDC, 2018). Eighty percent of patients are still considered idiopathic (without a genetically identifiable cause). Traditionally, drug developers have approached ASD as a single-disease entity, overlooking its clinical complexity and biological heterogeneity.
STP1 has been developed using STALICLA´s innovative systems biology-driven platform (DEPI), which is an integrative framework that uses large-scale genetic, molecular, pharmacological and clinical data to define patient subgroups in ASD and to identify personalized treatments.
This is the first time that such technologies have been utilized within the field of neurodevelopment, and it is a hugely exciting project with scope to change the direction of this speciality.
STALICLA will submit its STP1 IND to enter a Phase 1b clinical trial.
The First ‘Phenotype 1’ ASD patients will be enrolled in early 2020.
STALICLA is a near clinical Swiss Biotech Company developing a unique approach to bring personalized medicine to patients with ASD. Today, patients with ASD account for approximately 1.5% of the world’s population, and the condition remains a high unmet medical need.
In its Geneva and Barcelona units, STALICLA has assembled world-class teams of experienced drug developers and computational biologists. The Company is recognized as a disruptive player, using its systems biology DEPI platform to identify subgroups of patients with ASD and candidate repurposed and rescued drugs. Patients are then characterized through biomarker preclinical and clinical investigations. This translates into a derisked drug development process bringing the vision of ASD personalized medicine to reality.
STALICLA’s first investigational precision medicine - STP1 - addresses a distinct subgroup of ASD patients estimated to 2 million people in Europe and North America. To support STP1’s development and create strong value for all stakeholders, STALICLA has developed a network of top-tier research and clinical partners and established IP as a strategic priority. STALICLA is currently applying its DEPI discovery model to characterize additional subgroups of patients and advance new pipelines. Applicability of the DEPI platform goes beyond ASD and has potential for drug discovery in other complex ill-defined diseases.
0041 (0) 22 545 12 42
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Strong Revenue Growth in 2019 and Promising Outlook22.1.2020 16:45:00 CET | Press release
Kalray (Paris:ALKAL) (Euronext Growth Paris : ALKAL), a pioneer in processors for new intelligent systems, reviews its business in the second half of 2019 (from July 1 to December 31, 2019) and looks back over the highlights of the period. Eric Baissus, President of Kalray’s Executive Board, commented as follows: “2019 was a pivotal year for Kalray marked by the achievement of a number of key milestones. First of all, we finished developing our 3rd generation Coolidge™ processor and presented it for the first time in early January at CES. Mass production is scheduled to start second semester of 2020. Furthermore, strategic agreements were signed with top-tier players including NXP, Wistron, 2CRSI and Intron Technology, which will boost our credibility and accelerate time to market for Coolidge™. Our target of achieving revenues of €100 million by 2022 have been confirmed by the initial performances of Coolidge™, the industry enthusiasm which we were able to measure at CES and the numer
PMI Salary Survey Reveals Project Management Practitioners with the PMP Certification Earn 22% More22.1.2020 16:30:00 CET | Press release
The Project Management Institute (PMI) today released its “Earning Power: Project Management Salary Survey” which reveals a significant advantage in earning potential for practitioners who hold the Project Management Professional (PMP)® certification. According to the survey, respondents with a PMP certification reported higher median salaries than those without a PMP certification -- 22% higher on average across the 42 countries surveyed. New in this edition is salary information from five countries not previously covered— Indonesia, Pakistan, the Philippines, Portugal and the Russian Federation. The 11th edition of the survey incorporates information from more than 32,000 project management practitioners in 42 countries across the globe. The comprehensive biennial survey offers insight into the value of project management skills, experience and certifications. It is an industry-leading source of data, giving project management practitioners a greater awareness of their earning potent
Philip Morris International Wins 2020 BIG Innovation Award22.1.2020 15:05:00 CET | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced that it has won the 2020 BIG Innovation Award in the “Organization” category. The company was honored for placing innovation front and center as it continues its full-scale business transformation to deliver a smoke-free future and replace cigarettes with better alternatives for those adults who would otherwise continue to smoke. The BIG Innovation Awards, presented by the Business Intelligence Group, recognize organizations, products and people who bring new ideas to life. Organizations from across the globe submitted their recent innovations for consideration, and nominations were judged by a select group of business leaders and executives. “It is gratifying to continue to be recognized by the broader business community for the innovation that is fueling our progress toward a smoke-free future,” said Jacek Olczak, PMI’s chief operating officer. “As we are undergoing the largest transformation in our company’s history,
Sevan Refreshes 14,000th Restaurant22.1.2020 14:00:00 CET | Press release
Sevan Multi-Site Solutions, Inc. (Sevan)—a global leader in innovative design, program management, construction services and data analytics—just finished refreshing their 14,000th restaurant. For eight years, Sevan has provided solutions for the world’s largest brands while accelerating development programs across the United States and Canada for multi-site clients. Sevan has partnered on restaurant programs with Carl’s Jr., Carrols Corporation (a Burger King franchisee), Chipotle, McDonald’s, Panera, Starbucks, Taco Bell, Army & Air Force Exchange Service (Exchange) restaurants and others. Sevan’s Chief Revenue Officer Jim Furis says working with great clients is the best part of the company’s success in the Quick Service Restaurant (QSR) world. “Each client is unique and their project execution style varies widely. Not surprisingly, they all share one objective—to deliver a fantastic customer experience in a reliable way at loads of locations,” Furis said. “Sevan is proud to have pla
Mary Kay Inc. Celebrates Milestone Anniversaries Around the World22.1.2020 13:50:00 CET | Press release
Blow out the pink candles and make a wish—in 2020, Mary Kay Inc. will celebrate milestone anniversaries in some of its most important markets around the globe. The iconic Mary Kay Ash, with humble roots in small town, Texas, founded her namesake brand in 1963. The brand quickly developed into a worldwide phenomenon with millions of independent beauty consultants in nearly 40 countries. While beauty trends come and go, Mary Kay owes its staying power to something that never goes out of style: female empowerment and a greater purpose to do good. “While our innovative skin care, on-trend color cosmetics, fragrances and body care products have been loved for more than 56 years by millions of consumers around the world, our company was founded with much more than lipstick in mind,” said Deborah Gibbins, Chief Operating Officer at Mary Kay. “Our founder, Mary Kay Ash, built her dream company with two goals: create economic independence for women through entrepreneurship, and make the world a
H.I.G. Capital Invests in Greek Property Company22.1.2020 12:08:00 CET | Press release
H.I.G. Capital, LLC ("H.I.G."), a leading global private equity investment firm with over $35 billion of equity capital under management, announced today that one of its affiliates has recently provided debt and equity financing to Dimand SA, a leading Athens based property and development company. Funds will predominantly be used to finalise office and hotel developments in Athens. Terms were not disclosed. H.I.G. continues to add to its sizeable holdings of real estate assets across Europe, consisting of both equity as well as debt investments, with a focus on its target market of value-add small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty, commented: “We believe Greece presents good niche opportunities in a recovering real estate market. In this instance, we have invested in a high quality company with a strong asset base, and our preferred equity position provides significant downside protection.” Stelios Theodosiou, Principal at