REC-994
- Generic Name
- REC-994
- Drug Type
- Small Molecule
- Background
REC-994 was cleared by the FDA in July, 2018 for a phase I trial for the treatment of cerebral cavernous malformation (CCM).
Recursion Doses First Patient in Phase 1 Trial of REC-3565 for Relapsed B-cell Lymphomas
• Recursion has initiated the EXCELERIZE Phase 1 clinical trial of REC-3565, a selective MALT1 inhibitor designed to treat relapsed or refractory B-cell lymphomas.
• The AI-designed compound demonstrated strong preclinical results and features an allosteric design that potentially reduces liver toxicity risks associated with other MALT1 inhibitors.
• Approximately 41,000 relapsed/refractory patients with CLL and B-cell lymphomas in the U.S. and EU5 are eligible for this potential treatment annually.
Recursion-Exscientia Merger Signals New Era in AI-Driven Drug Discovery
• Recursion Pharmaceuticals and Exscientia have completed a landmark $700 million merger, marking the largest AI-focused life sciences deal to date and combining complementary capabilities in biological and chemical AI platforms.
• The merged entity now boasts 10 programs in development and significant partnerships with pharmaceutical giants Sanofi and Roche, with their most advanced program targeting cerebral cavernous malformation in Phase 2.
• Industry experts predict this merger will catalyze more AI-focused acquisitions in pharma, as companies seek to fully integrate artificial intelligence into traditional drug development processes.
Recursion's AI-Discovered Drug Shows Promise in Phase II Brain Disease Trial
• Recursion's lead AI-derived drug candidate REC-994 demonstrated significant efficacy in Phase II trials, with 50% of high-dose patients showing reduced brain lesion volume compared to 28% on placebo.
• The trial targeted cerebral cavernous malformation (CCM), a potentially fatal brain condition affecting 360,000 people in the US and EU, for which no approved pharmacological treatments currently exist.
• The positive results mark a milestone for AI-driven drug discovery, though experts note these outcomes reflect earlier AI technology rather than current capabilities.
Recursion's REC-994 Shows Promise in Phase II Trial for Cerebral Cavernous Malformations
• REC-994 demonstrated a favorable safety profile and improved functionality scores in Phase II trial for Cerebral Cavernous Malformations patients, marking a potential breakthrough for non-surgical treatment.
• The 400mg dose group showed notable reductions in cerebral lesion volume compared to placebo, though patient responses varied across the study population.
• With no current non-surgical treatments available for CCM, these positive results position REC-994 as a promising therapeutic candidate pending FDA discussions.
Recursion's REC-994 Shows Promising Safety and Efficacy Signals in Phase 2 CCM Trial
• REC-994 demonstrated a favorable safety profile in the Phase 2 SYCAMORE trial for Cerebral Cavernous Malformations, with no treatment-related discontinuations or serious adverse events.
• The 400mg dose showed encouraging efficacy signals, with 50% of patients experiencing lesion volume reduction and improved functional outcomes compared to placebo after 12 months of treatment.
• Particularly notable benefits were observed in patients with brainstem lesions, representing a significant advancement for this high-unmet-need population where surgical intervention is not possible.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
AI-Driven Drug Discovery Shows Promise and Challenges in Cerebral Cavernous Malformation Trial
• Recursion Pharmaceuticals' Phase 2 trial of REC-994 for cerebral cavernous malformation (CCM) met its primary safety endpoint but showed mixed efficacy results.
• The trial highlights the potential and challenges of using AI to analyze vast datasets for identifying new drug candidates for rare diseases.
• Experts suggest combining AI with traditional techniques and developing more complex models to improve the accuracy and reliability of AI-driven drug discovery.
• Accessibility of AI tools is crucial, with platforms streamlining the process for scientists to efficiently utilize these technologies in drug discovery.
Recursion's AI-Derived Drug REC-994 Shows Promise in Phase 2 Trial for Cerebral Cavernous Malformation
• Recursion Pharmaceuticals' REC-994 met the primary safety endpoint in a Phase 2 trial for cerebral cavernous malformation (CCM).
• Secondary endpoints suggest a reduction in lesion volume and hemosiderin ring size at the 400mg dose compared to placebo.
• The oral drug REC-994 has the potential to address the unmet needs of CCM patients who currently have limited treatment options.
• Recursion plans to engage with the FDA to discuss subsequent studies and present trial data at an upcoming medical conference.
Recursion Pharmaceuticals Announces Seven Clinical Readouts Expected Within 18 Months
• Recursion Pharmaceuticals anticipates seven clinical trial readouts within approximately 18 months, spanning multiple therapeutic areas and clinical phases.
• Key readouts include Phase 2 data for REC-994 in Cerebral Cavernous Malformation and REC-2282 in Neurofibromatosis Type 2, expected in September and Q4 2024, respectively.
• Recursion's partnership with Bayer expands with Bayer becoming the first beta-user of Recursion’s LOWE software for drug discovery.
• The company is advancing internal and partnered programs, leveraging AI/ML solutions and multimodal data to enhance drug discovery and development.
Recursion Anticipates Phase 2 Data Readouts and Advances Platform Capabilities
• Recursion expects to release Phase 2 data for REC-994 in Cerebral Cavernous Malformation in Q3 2024, with the SYCAMORE trial fully enrolled.
• Preliminary Phase 2 data for REC-2282 in Neurofibromatosis Type 2 is anticipated in Q4 2024, with adult enrollment expected to complete in Q2 2024.
• The company's BioHive-2 supercomputer nears completion, enhancing capabilities in constructing foundation models for biology and chemistry.
• A multi-year agreement with Helix provides access to extensive genomic and health record data for AI model training and patient stratification.
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