Business Wire

STALICLA Completes Successful Phase 1b Trials for the First Precision Medicine in Autism Spectrum Disorder

Share

STALICLA, a Swiss clinical stage biotech company leading omics-based drug development for patients with neurodevelopmental disorders (NDDs), announced today the highly successful completion of the phase 1b trials for its lead drug candidate STP1. These clinical data clear the way for a first application of STALICLA’s precision medicine discovery platform in autism spectrum disorders.

The goal of this phase 1b, double-blind, placebo-controlled study was to evaluate the safety, tolerability, and pharmacokinetics of a two-week oral treatment with STP1 in a subgroup of patients with ASD. In addition to showing good safety and tolerability profiles, and dose-dependent target engagement, STP1 treatment resulted in positive signals in clinical markers of neurological and behavioral function, including improved processing speed and crystallized cognition composite.

Speaking about the results, Dr Craig Erickson, M.D. – lead investigator at Cincinnati Children’s Hospital said: “The electrophysiological signals from this study are remarkable and represent the strongest early trial target engagement signals our lab has seen in the autism field. The findings from this project de-risk future larger-scale study given the personalized approach employed to biologically identify specific autistic individuals who may best respond to a treatment prior to study enrollment.”

Baltazar Gomez Mancilla, STALICAL’s CMO, added: “Beyond molecular impact, we are seeing a dose-related decrease of specific abnormal electrophysiological signal in brain regions related to social interaction, working memory and processing speed that may lead to social communication improvement, which is one of the core symptoms of autism. Those results and the prospects of a personalized solution addressing ASD could be a tremendous game-changer for this subgroup of patients representing 20% of ASD population.”

STALICLA drug development relies on DEPI, the AI-driven and clinically validated biotech platform integrating comprehensive metabolomics, whole-genome sequencing, RNA sequencing and a proprietary module to pair patient biological signatures with drug candidates. Using DEPI, STALICLA already proved the clinical validity of several subgroups with neurodevelopmental disorders (Phen1, Phen2, Phen3, Phen5) and their respective tailored treatments, starting with STP1.

Speaking about next steps, Lynn Durham, STALICLA’s CEO & Founder, commented: “We are now turning our sights to the next stage of our growth with some major milestones. First, a multicenter bio sampling study for the enrollment of STP1 phase 2, which should allow us to gather the most comprehensive clinical and multi-omics data set to date in the ASD space. Then, the continuation of STP1 phase 2, increasing treatment duration and dose level, adding a working memory test, and further refining phase 1b's strong findings. Finally, our other milestones will include phase 2 trials for our second precision drug candidate STP2, partnerships’ development and the in-licensing of potential additional compounds. In order to finance this growth, we are currently raising a series B of USD 65M, with target completion Q2-Q3 2022.”

About STALICLA

STALICLA SA is a Swiss clinical stage biopharmaceutical company leading omics-based precision medicine drug development for patients with neurodevelopmental disorders (NDDs), with a first application in autism spectrum disorder (ASD). STALICLA is on a unique mission to identify clinically actionable patient subgroups and develop tailored treatments for those most impaired by their symptoms. Its DEPI technology is the first platform specifically developed to enable precision medicine in complex NDDs. The platform integrates comprehensive metabolomics, whole-genome sequencing, RNA sequencing and its advanced HC match module to pair patient biological signatures with drug candidates. DEPI has reached clinical proof of concept with its first pipeline candidate, STP1. STALICLA is advancing collaborative alliances with strategic third-party pipelines and is rapidly scaling its platform and clinical development activity. For more information, please visit: https://stalicla.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

STALICLA
Lynn Durham, CEO and Founder
Lynn.Durham@Stalicla.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Align Technology Introduces Invisalign Outcome Simulator Pro, Next Generation Patient Communication Tool Featuring In-Face Visualization of a Patient’s Potential Future Smile in Minutes19.5.2022 22:41:00 CEST | Press release

Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today introduced Invisalign Outcome Simulator Pro, the next generation of its advanced patient communication tool. This enables doctors to show patients their potential new smile after Invisalign treatment, using in-face visualization and/or 3D dentition view, all done chairside in minutes. Invisalign Outcome Simulator Pro is available on iTero Element Plus Series scanners and imaging systems. Invisalign Outcome Simulator Pro expands Align’s existing Invisalign Outcome Simulator technology and adds the benefits of the Company’s ClinCheck “In-Face” Visualization tool that combines a photo of a patient’s face with their 3D treatment simulation, creating a truly personalized view of how their new smile could look. This

New Conviva Data Shows Double Digit Streaming Growth Worldwide; Smart TVs Growing Rapidly as Streaming Moves to Overtake Linear on the Big Screen19.5.2022 21:01:00 CEST | Press release

Global streaming grew 10% globally, including continued growth in mature markets like North America (5%) and Europe (9%), during the first quarter of 2022 as compared to Q1 2021, according to the latest State of Streaming report from Conviva, the continuous measurement analytics platform for streaming media. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005871/en/ Conviva's Q1 2022 State of Streaming Report Available Now! (Photo: Business Wire) “Despite recent news of Netflix’s subscriber contraction, streaming continues to grow worldwide, encompassing an ever-growing stable of platforms offering unique and original content,” said Keith Zubchevich, President and CEO, Conviva. “In mature markets like the US and Europe, viewers are upscreening from small devices to Smart TVs, setting the foundation for streaming to overtake linear TV on the big screen.” Conviva’s Q1 2022 report found big screens (which includes connecte

xFusion Held the European Partner Summit Under the Theme of "Together for a Better Future"19.5.2022 19:00:00 CEST | Press release

On May 19, xFusion held its first 2022 European Partner Summit in Paris, under the theme of "Together for a Better Future." xFusion Digital Technologies Co., Ltd. invited dozens of core partners from more than 10 countries, including France, Germany, Switzerland, Sweden, Poland, Hungary, and countries in the Nordic region to discuss the future and new value exploitation of the industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005813/en/ (Photo: Business Wire) Terry Fang, President of xFusion Global Marketing and Sales Department, gave a welcome speech on behalf of xFusion. Intel and other partners then shared the latest concepts and practices within the European digital economy, focusing on topics such as industrial digitization and intelligentization, while offering suggestions for the development of industrial digital intelligence. Cooperation with Partners for a New European Digital Ecosystem Europe is transi

RMS Expands Global Risk Views Coverage19.5.2022 16:30:00 CEST | Press release

RMS®, a Moody’s Analytics company and world-leading risk modeling and solutions company, announces it will be launching new global views for acute and chronic perils and their climate change impact. RMS already offers a range of regional peril and climate change models, which support detailed acute physical loss modeling products, as well as data products covering hazard and risk scores, and loss costs for individual locations, across multiple time horizons. RMS climate change models and data products have been welcomed by the market, and allow users to stress test portfolio management, risk mitigation, and adaption strategies. The newly announced global views significantly extend RMS’s peril and climate change impact coverage to provide fully correlated global views of risk, and include event frequency and severity, and analysis for current baseline and future climate views. With these new global views, RMS not only delivers a view of risk for acute peril-specific risks, but also chro

Envision the Future and Take on the Power of Computing with GIGABYTE at COMPUTEX 202219.5.2022 16:29:00 CEST | Press release

GIGABYTE, a world leader in computer technology, will be presenting “Power of Computing” as its theme of the year, and exhibiting its leading products and solutions designed for various industries and fields in the upcoming COMPUTEX Taipei. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005640/en/ Envision the Future and Take on the Power of Computing with GIGABYTE at COMPUTEX 2022 GIGABYTE has curated its presentation around the theme “Power of Computing” to demonstrate that, everything from the cloud to the edge, from team collaboration to individual creation, from business applications to personal use, computing done by servers in data centers to process massive data and embedded systems in IoT and personal computers to render real-time information is the key behind groundbreaking innovations that appear in the fields of AI, cloud deployment, smart technologies, and digital content creation, etc. Data Center is an i