STALICLA
24.3.2022 17:38:13 CET | Business Wire | Press release
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220324005694/en/
Link:
About Business Wire
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
Vertex Presents New Data on ALYFTREK® at European Cystic Fibrosis Conference5.6.2026 18:00:00 CEST | Press release
- ALYFTREK Phase 3 data on children with cystic fibrosis ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including F/F and F/MF shows 65% reached sweat chloride levels of <30 mmol/L; Vertex on track to initiate global regulatory submissions in first half of 2026 - - Long-term 96-week interim analyses from two open-label extension studies demonstrate positive safety and efficacy profile of ALYFTREK in people with cystic fibrosis ages 6 and older -- Phase 3 data on TRIKAFTA® in children 1 to <2 years also presented; Vertex has initiated global regulatory submissions - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data demonstrating the potentially transformative impact of treating cystic fibrosis (CF) with ALYFTREK ® (vanzacaftor/tezacaftor/deutivacaftor) in children ages 2 to 5, as well as data from 96-week interim analyses of two open-label extension studies of ALYFTREK in children 6 to 11 years and people 12 years and older demonstrating
Owkin to Build AI Agents as Part of a Multi-Year K Pro Collaboration with Sanofi5.6.2026 13:00:00 CEST | Press release
Owkin, the agentic AI company pioneering Biological Artificial Superintelligence to transform drug discovery and development, today announced a multi-year collaboration with Sanofi to co-develop next-generation biopharma agents, to be backed by a five-year license for K Pro, Owkin’s AI Scientist. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260605704506/en/ K Pro, Owkin's AI scientist for biology, powered by multimodal patient data for smarter biopharma decision making. Owkin and Sanofi have collaborated since 2021 through a €90 million strategic partnership focused on target identification in oncology and patient subgrouping. The collaboration was later expanded to include drug positioning for Sanofi’s immunology pipeline. This new collaboration represents the next evolution in the partnership. During the five-year collaboration, Owkin will lead the end-to-end development of novel AI-driven biopharma agents purpose-built
DFNS Rebrands as the Core Banking Platform for Digital Assets5.6.2026 12:41:00 CEST | Press release
DFNS today announced a rebrand, marking its evolution from a wallet infrastructure to the first core banking platform for digital assets. The company is introducing a new logo, website, and market position as fintechs and institutions move their products and operations onchain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603859127/en/ Banks, fintechs, asset managers, trading firms, payment providers, market infrastructures, and clearing houses have stopped asking how to "add crypto." They're asking how to run financial products, controls, workflows, and client services on blockchain rails, with the reliability expected of core infrastructure. Some are going further still, exploring whether the blockchain can serve as the ledger itself, where an account is an onchain object rather than a row in a database. Where IBANs, virtual accounts, and blockchain wallets converge into one governed financial account. “DFNS was built
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.6.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seventeen newly hired non-executive employees. The equity awards were granted on June 1, 2026 and consisted of options to purchase an aggregate of 157,000 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 74,700 shares. The options have an exercise price per share equal to $14.19, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restrict
Renewable Electricity, Soft Wheat Flour From Regenerative Agriculture, Initiatives to Support Local Communities: Barilla Shares These and Other Projects in “Stories of Sustainability.”5.6.2026 10:00:00 CEST | Press release
Barilla continues to advance its commitment to tastier products with less sugar and salt;An investment of 30 million euros in 2025 to quadruple photovoltaic capacity across plants, as part of a €168 million five-year plan focused on energy efficiency, renewable energy and sustainable water management.Barilla continues to expand regenerative agriculture practices across its global value chain, with over 816,000 tons of raw materials sourced through the Barilla Sustainable Farming program.4,000 tons of products donated worldwide and €2 million allocated to social causes in 2025, supporting communities across Barilla’s global footprint through food donations and social initiatives. A slimmer Tagliatelle pack that saves 150 tons of cardboard and cuts transport-related CO₂ emissions by 20%1; ready-made sauce jars made with around 65% recycled glass; the progressive scaling of regenerative agriculture practices across Barilla’s value chain and initiatives supporting inclusion and equal oppor
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom