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
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro
Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 11:00:00 CEST | Press release
Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely
MTG-I2 Safely in Orbit, Unlocking Faster and Sharper Weather Monitoring Across Europe28.8.2026 10:16:00 CEST | Press release
The Meteosat Third Generation Imager 2 satellite (MTG-I2) has successfully passed its first critical post-launch milestones, completing the first full Meteosat Third Generation constellation in orbit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828243790/en/ Credit: Arianespace livestream The imager satellite MTG-I2 is safely in orbit and operating as expected following its successful launch yesterday at 22:11 CEST on board an Ariane 6 rocket from Europe’s Spaceport in French Guiana. Our teams have established communication with the spacecraft, which has also deployed its solar panels to ensure its autonomous production of energy. MTG-I2 is in perfect shape to start its Launch and Early Operations Phase that will bring it to a higher orbit, 36 000km above Earth over the following two weeks, where a longer period of calibration and validation of its instruments will begin. This summer’s extreme weather and wildfires hav
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