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This Phase I clinical trial will assess the safety and tolerability of CTH120, which acts as a neuroplasticity modulator. CTH120 has shown very promising results in preclinical studies carried out at Dr Mara Dierssen research lab at the Centre for Genomic Regulation in Barcelona. The study will take place at Hospital del Mar Research Institute, led by Dr Rafael de la Torre and Dr Ana Aldea as principal investigators. María Martínez de Lagrán, Jordi Fàbrega, Mara Dierssen, Josep Prous, Ana Aldea and Rafael de la Torre, representing Connecta, CRG and Hospital del Mar Research Institute Connecta Therapeutics, a clinical stage biotechnology company focusing on the development of new treatments for central nervous system (CNS) disorders without therapeutic options, has been granted authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) to start Phase I clinical trials on its drug CTH120 for the treatment of Fragile X syndrome (FXS). The study will take place at Hospital del Mar Research Institute in Barcelona, with Dr Rafael de la Torre, director of the Neuroscience Research Programme at Hospital del Mar Research Institute, and Dr Ana Aldea, coordinator of the Clinical Research Unit at Hospital del Mar Research Institute and head of the Clinical Pharmacology Section at Hospital del Mar, as principal investigators. It is a double-blind, placebo-controlled trial that aims to assess the safety and tolerability of CTH120, a first-in-class molecule designed using artificial intelligence that modulates neuroplasticity and has proven in preclinical studies to improve cognitive capacity and reverse behavioural manifestations of neurodevelopmental disorders. The study will recruit 70 healthy adults, both men and women. CTH120 has been developed with contributions from the team led by Dr Mara Dierssen, head of the Cellular and Systems Neurobiology group in the Synthetic and Systems Biology Programme of the Centre for Genomic Regulation (CRG) and member of the Connecta Therapeutics scientific advisory board. The researchers Juan Luis Musoles and María Martínez de Lagrán have participated in these studies. “We are very proud that Hospital del Mar Research Institute will be carrying out the clinical trial for an FXS treatment, which is a hereditary genetic neurodevelopmental disorder related to the X chromosome that causes mild to severe intellectual disability,” said Dr Rafael de la Torre. FXS, which has no specific treatment, is estimated to affect fewer than 3 in 10,000 inhabitants. “It is very important to find a therapeutic solution for FXS, currently considered the most common cause of inherited intellectual disability. CTH120 brings new hope for patients with this minority disease all over the world,” highlighted Dr Ana Aldea. “The polypharmacological pro CTH120 is a novel approach that acts simultaneously on cognitive and sociability aspects characteristic of neurodevelopmental diseases,” noted Dr Mara Dierssen. “In preclinical studies, we’ve seen that CTH120 has great potential as an effective, safe therapeutic option for FXS patients, not only to alleviate their symptoms but also to tackle the origin of the condition,” explained Dr Josep Prous, co-founder and Chief Scientific Officer of Connecta Therapeutics. “The final results of the Phase I trial are expected in the second quarter of 2024. If they’re positive and back the safety of our drug, we’ll continue with Phase II clinical trials to study the efficacy of the drug in patients as soon as possible,” said Jordi Fàbrega, co-founder and CEO of Connecta Therapeutics. CTH120 has been granted orphan drug designation from the European Medicines Agency. The company was recently granted a participatory loan for €600,000 from the Spanish National Innovation Company (Enisa). This funding reinforces Connecta Therapeutics’ CNS research activities. Since it was founded in 2019, Connecta Therapeutics has raised over €5 million, including venture capital (Inveready and CDTI through the Innvierte programme) and various competitive public programmes. More information:

Almirall SA and biomedical research institute, the Centre for Genomic Regulation (CRG), have announced a collaboration aimed at developing and distinguishing novel preclinical models to identify new treatments for non-melanoma skin cancer (NMSC). NMSC belongs to a group of cancers that develop in the upper layers of the skin. Non-melanoma specifies more common kinds of skin cancer from the less common kind known as melanoma. The two most common types of NMSC are squamous cell carcinoma and basal cell carcinoma, representing 70% and 25% of NMSC cases, respectively. Squamous cell carcinoma starts in the cells lining the top of the epidermis, while basal cell carcinoma starts in the cells lining the bottom of the epidermis. Through the new partnership, Almirall investigators and CRG’s team of researchers will merge their knowledge to inaugurate experimental models that allow identification, as well as validation of new therapeutic approaches and the evaluation of new drugs for these diseases. CRG’s group leader, professor Luciano Di Croce, said: “NMSC is not an aggressive cancer, meaning it has been historically difficult to model this disease in the lab. However, important technological advances combined with multiple 'omics’ approaches allow now to create truly functional scientific models for this skin cancer. “Thus, it is an exciting opportunity to collaborate with Almirall and make important advances in studying one of the most frequent types of cancer." The research partnership arises after AlmirallShare – the company’s open innovation platform for discovering innovative therapies for skin diseases – made a call for proposals. Formed in 2017, AlmirallShare was created to make dermatological research collaborations easier and accelerate the development of skin condition treatments. The collaboration between Almirall and CRG represents another milestone in this endeavour, the company said, and builds on the eight established partnerships based on models, targets and new therapies for dermatological disease, including hidradenitis suppurativa. Almirall’s chief scientific officer, Karl Ziegelbauer, said: “This collaboration with CRG brings us closer to our noble purpose of delivering world-class solutions that make a difference in patients' lives. "It also reaffirms the success of our open innovation platform AlmirallShare as a key tool for building strategic partnerships.”