Rapport Therapeutics, Inc. engages in the discovery and development of transformational small molecule medicines for patients suffering from central nervous system disorders. It develops the RAP (receptor associated proteins) technology platform. The company was founded by Steven M. Paul and David Bredt in February 2022 and is headquartered in Boston, MA.
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- Rapport Therapeutics' RAP-219 achieved target receptor occupancy within five days, supporting its potential for treating CNS disorders. - The Phase 1 trials demonstrated a favorable tolerability profile for RAP-219, with no serious adverse events reported in healthy volunteers. - RAP-219 selectively targets TARPγ8-associated AMPA receptors, potentially enhancing the therapeutic index for AMPA receptor modulation. - A Phase 2a trial of RAP-219 in focal epilepsy is ongoing, with topline data expected in mid-2025, according to Rapport Therapeutics.
- Rapport Therapeutics presents data linking reductions in long episode (LE) frequency to clinical seizure reduction in focal epilepsy. - A 30% reduction in LEs correlates with a 50% or greater reduction in clinical seizures, establishing a benchmark for RAP-219. - RAP-219, a selective TARPγ8 NAM, demonstrates potential for improved tolerability and efficacy in treating refractory focal epilepsy. - Phase 2a trial topline data for RAP-219 in focal epilepsy is expected in mid-2025, marking a key milestone for the program.
• The FDA has placed a clinical hold on Rapport Therapeutics' RAP-219 IND application for diabetic peripheral neuropathic pain (DPNP) due to protocol design concerns. • A phase 2 trial (cAPPricorn-1) will evaluate Alnylam's mivelsiran, an RNAi therapeutic targeting APP, for cerebral amyloid angiopathy (CAA) in a 200-patient global study. • The FDA has accepted PTC Therapeutics' resubmitted NDA for ataluren to treat nonsense mutation Duchenne muscular dystrophy (nmDMD), with no PDUFA date set.
- Rapport Therapeutics is advancing RAP-219, a precision medicine for CNS disorders, with Phase 2a trial in focal epilepsy on track for mid-2025 data. - A clinical hold was placed on the RAP-219 trial for diabetic peripheral neuropathic pain (DPNP) by the FDA, pending protocol amendments. - The company's MAD-2 and PET trials of RAP-219 are ongoing, with topline data expected in Q1 2025, informing bipolar disorder treatment. - Rapport Therapeutics ended Q3 2024 with $320.7 million in cash, expected to fund operations through 2026, and appointed new board members.
- The FDA has placed a clinical hold on Rapport Therapeutics' IND application for RAP-219, an investigational therapy for diabetic peripheral neuropathic pain (DPNP). - The agency is requesting additional information on the trial's protocol design, which Rapport Therapeutics believes it can address promptly. - This hold does not affect Rapport's other RAP-219 studies, including the ongoing Phase 2a trial for focal epilepsy and planned trial for bipolar disorder. - Rapport Therapeutics anticipates providing an update on the Phase 2a trial initiation timeline once the FDA's requests are resolved.
- Rapport Therapeutics is advancing RAP-219 in Phase 2a trials for focal epilepsy, with topline data expected in mid-2025, showing commitment to CNS disorder treatments. - The FDA placed a clinical hold on Rapport's RAP-219 trial for diabetic peripheral neuropathic pain, prompting the company to address protocol feedback. - The company appointed biotech leaders to its Board of Directors and reported $320.7 million in cash, expected to fund operations through 2026. - Rapport is set to release topline data from the RAP-219 MAD-2 and PET trials in Q1 2025, informing the bipolar disorder trial and target receptor occupancy.
- Rapport Therapeutics is progressing with Phase 2a trial of RAP-219 in focal epilepsy, with topline data expected in mid-2025. - Multiple Ascending Dose (MAD-2) and PET trials of RAP-219 are ongoing, with topline results anticipated in Q1 2025. - The FDA placed a clinical hold on the IND for RAP-219 in diabetic peripheral neuropathic pain, pending protocol amendments. - New biotech industry leaders have been appointed to Rapport's Board of Directors, bringing expertise in drug discovery and clinical development.
• Rapport Therapeutics receives a Buy rating from JonesTrading, driven by its innovative RAP platform targeting central nervous system disorders. • RAP-219, Rapport's lead candidate, shows promise for treating epilepsy, pain, and bipolar disorder by targeting TARPγ8, with Phase II trials planned for 2025. • Integration of NeuroPace's RNS device could enhance clinical proof of concept for RAP-219, improving patient recruitment and trial outcomes. • Strategic focus on selective targeting aims to minimize side effects, potentially positioning RAP-219 as a best-in-class treatment.
