Latest news with #Seyltx
Business Wire
4 days ago
- Business
- Business Wire
Seyltx Expands GluN2B Antagonist Pipeline with Clinical-Stage and Small-Molecule Candidates for Chronic Cough
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seyltx, Inc., ('Seyltx', 'Company') a clinical-stage biotherapeutics company focused on developing therapies to treat chronic cough, today announced it has entered into an option agreement with NeurOp, Inc. ('NeurOp'') for a portfolio of novel GluN2B antagonists. This agreement provides Seyltx with an option to worldwide, exclusive rights to develop and commercialize a portfolio of GluN2B negative allosteric modulators (NAMs) for treating chronic cough in humans, including in refractory chronic cough (RCC) and chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). "We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx's CEO. This strategic agreement combines Seyltx's expertise in chronic cough therapeutic development with NeurOp's expertise in NMDA receptor biology and innovative GluN2B inhibitors. This combination complements and deepens Seyltx's ongoing development of Ifenprodil, a potent NMDA antagonist that is highly selective towards the GluN2B subunit, currently in Phase 2 development. The combined effort is expected to accelerate the development and commercialization of new therapies for chronic cough and solidify Seyltx's position as a leader in addressing this significant unmet medical need. The option agreement includes 8 novel compounds, including NP10679, which has completed Phase 1 and provides Seyltx with a second clinical-phase candidate, with the potential to provide differentiated performance compared to Ifenprodil. These compounds have excellent potency, selectivity, pharmacokinetics, solubility, and metabolism. Strong intellectual property exists across all optioned compounds. "We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx's CEO. "Refractory chronic cough impacts approximately 6 million people in the USA alone, representing a substantial unmet medical need. Furthermore, chronic cough associated with IPF, an orphan condition affecting up to 140,000 people in the US, is a primary driver of deteriorated quality of life for these patients. Our agreement with NeurOp for advanced GluN2B NAMs, particularly NP10679, offers a promising avenue to provide potentially superior treatment options to these patients by addressing the condition with a centrally acting non-narcotic solution." Dr. James McNamara, Executive Chairman of NeurOp added, "NeurOp has been dedicated to advancing novel GluN2B-targeted therapies. This agreement with Seyltx is a testament to the sophistication of our team's expertise in the NMDA receptor biology and the development of our GluN2B antagonists. Seyltx's deep understanding and focus on chronic cough make them an ideal partner to further develop and bring these important compounds to patients in need. We look forward to a very productive partnership." NMDA is a validated therapeutic target in cough, with the only FDA-approved cough therapy being a non-specific NMDA antagonist. Preclinical research has identified the GluN2B subunit of NMDA as a primary target for cough suppression. Traditional non-specific NMDA antagonists have demonstrated limited efficacy due to dose limiting side effects. However, specifically targeting the GluN2B subunit, provides the potential to achieve robust cough suppression, while avoiding the adverse event profile observed with non-specific NMDA antagonists. The addition of NP10679 to the portfolio provides the opportunity to effectively engage the GluN2B receptor, below the safety threshold established in Phase 1, while offering a differentiated selectivity and efficacy profile compared to Ifenprodil. The option agreement has been approved by the management of both companies with a conversion to an exclusive world-wide license agreement anticipated within 12 months. About Seyltx: Seyltx ( is a clinical stage biotherapeutics company focused on developing innovative therapies to treat chronic cough and other neuronal hypersensitivity indications. Its lead indication is refractory chronic cough, a significant unmet medical need, with a follow-on opportunity in chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). Seyltx's lead compound is Ifenprodil, an NMDA receptor inhibitor highly selective towards the GluN2B subunit, which has completed a Phase 2a trial in chronic cough associated with IPF, with statistically significant reductions in cough from baseline at 12-weeks, and statistically significant improvements on all patient reported outcomes employed. Seyltx is currently progressing into Phase 2 crossover trials. About NeurOp: NeurOp, Inc. is a privately held, clinical-stage biopharmaceutical company based in Atlanta, Georgia that is developing small-molecule therapies for central nervous system disorders, including severe pain, treatment-resistant depression, subarachnoid hemorrhage (SAH) and stroke. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors and are designed for potential therapeutic benefit with an improved safety and tolerability profile relative to other NMDA receptor antagonists. Forward-Looking Statements: Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'potential,' 'possible,' 'projects,' 'plans,' and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond Seyltx's control.
Yahoo
4 days ago
- Business
- Yahoo
Seyltx Announces Positive Non-Human Primate (NHP) and Additional In Vivo Data for its Centrally Acting Inhibitor of GluN2B in Chronic Cough, Paving the Way for Optimized Later-Stage Phase 2 Trials
- Results will be presented at the American Cough Conference on June 7, 2025 - NHP receptor occupancy studies indicate increasing the dose in Phase 2 from 20 mg to 40-80 mg is likely to significantly increase cough suppression before receptor saturation - Oral administration in the Guinea pig model shows cough suppression up to 74% from baseline while staying under the NOAEL - Durability of cough suppression over time promises cough control with TID dose regimen and opens opportunity for once daily reformulation CAMBRIDGE, Mass., June 05, 2025--(BUSINESS WIRE)--Seyltx, Inc. a clinical-stage biotherapeutics company focused on developing innovative therapies to treat chronic cough and other neuronal hypersensitivity indications, today announced promising preclinical results for its lead compound, Ifenprodil. These new findings, to be presented at the American Cough Conference on June 7, 2025, offer critical insights into optimal dosing strategies and therapeutic durability, which will significantly inform the design of upcoming Phase 2 crossover studies planned for 2026. Ifenprodil, a NMDA antagonist with >200x selectivity towards the GluN2B subunit, is being developed to address refractory chronic cough (RCC), a significant unmet medical need, with a follow-on opportunity in chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). The company has already completed a Phase 2a trial in IPF-Cough at an exploratory low dose (20 mg TID) which yielded statistically significant reductions in objective cough count of 39% from baseline (at 12 weeks) and statistically significant improvement on multiple patient-reported outcomes. A NHP receptor occupancy (RO) study, conducted in collaboration with Yale University, was performed whereby rhesus monkeys underwent 120-minute PET scans following the intravenous injection of 135 ± 64 MBq (S)-[18F]OF-NB1 (tracer molecule). Ifenprodil was administered via 10-minute intravenous infusion at doses from 0.025 to 1 mg/kg (corresponding to oral human equivalent doses (HED) of 10-400 mg), with PET acquisition commencing 15' post-infusion. Dose-dependent GluN2B receptor occupancy was observed with a calculated EC50 (50% occupancy) of 0.04 mg/kg (HED of ~20 mg) and approximately 80% receptor occupancy predicted at 0.2 mg/kg (HED of ~80 mg). Doses between 40-80 mg TID are therefore expected to achieve 60-80% receptor occupancy, significantly enhancing therapeutic effects compared to the 20 mg TID dose used in the prior Phase 2a trial. In vivo studies conducted in Guinea pigs (GPs; 6-16 animals per group) assessed the antitussive effect of oral doses of Ifenprodil ranging from 1.5 mg/kg to 12 mg/kg (human equivalent doses of 20 to 160 mg). Ifenprodil demonstrated statistically significant (p<0.01) cough count reduction across the dose range of 39-74% following exposure to a tussive agent (1M citric acid). The lowest tested dose of 1.5 mg/kg (HED of 20 mg) resulted in a 39.1% reduction in cough count from baseline, consistent with the 39% reduction seen in the Phase 2a trial. Doubling this dose to an HED of 40 mg TID, which is well-tolerated in humans, improved the cough suppression to 56.0% reduction from baseline. A maximal reduction of 74.4% from baseline was observed at 12 mg/kg (HED 160 mg), a dose under the estimated NOAEL. The therapeutic effect proved durable, lasting up to 8 hours, even as systemic levels of Ifenprodil were cleared. This robust target engagement at the GluN2B subunit supports durable cough control with a TID (three times daily) dose regimen and opens the door for potential once-daily reformulation. These combined preclinical findings suggest an optimal human dose range of 40 to 80 mg for maximal therapeutic benefit, with the 80 mg dose yielding approximately 80% receptor occupancy, safely below levels that have shown adverse events in preclinical models. "These compelling preclinical results represent a significant leap forward in our understanding of Ifenprodil's potential to provide meaningful relief for patients suffering from chronic cough," said Dr. Dietrich Stephan, CEO of Seyltx. "The data not only confirms Ifenprodil's robust antitussive properties but also provides invaluable guidance on optimizing our dosing strategy for future clinical trials. We are excited to integrate these learnings into the design of our upcoming Phase 2 studies, bringing us closer to delivering a truly impactful therapy for this debilitating condition." Dr. Stephan further emphasized, "The promise of addressing GluN2B in the brain is that this target appears to be a central node in the cough reflex, likely providing significant cough control as a monotherapy without addictive potential across the population independent of etiology, if the preclinical data is translatable. The agent also has the potential to be used in combination with future peripherally acting therapies that might be approved." Seyltx plans to incorporate these key learnings into the design of its Phase 2 crossover studies, slated to commence in 2026. About Seyltx: Seyltx ( is a clinical stage biotherapeutics company focused on developing innovative therapies to treat chronic cough and other neuronal hypersensitivity indications. Its lead indication is refractory chronic cough, a significant unmet medical need, with a follow-on opportunity in chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). Seyltx's lead compound is Ifenprodil, an NMDA antagonist highly selective towards the GluN2B subunit, has completed a Phase 2a trial in chronic cough associated with IPF. Forward-Looking Statements: Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "estimates," "potential," "possible," "projects," "plans," and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond Seyltx's control. View source version on Contacts Parag ShahChief Operating Officerpshah@ Connectez-vous pour accéder à votre portefeuille
