Latest news with #VentusTherapeutics
National Post
22-05-2025
- Health
- National Post
Ventus Therapeutics to Present Phase 1 Results for VENT-03, a First-in-Class cGAS Inhibitor, at LUPUS 2025
Article content WALTHAM, Mass. & MONTREAL — Ventus Therapeutics, a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders, today announced the upcoming presentation of the Phase 1 safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) results of VENT-03 at the 16 th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), taking place from May 21-24 in Toronto, Canada. Article content VENT-03 is the first oral small-molecule cyclic GMP-AMP synthase (cGAS) inhibitor to successfully complete a first-in-human Phase 1 study and was discovered using Ventus' proprietary ReSOLVE ® platform. Data from the Phase 1 study, initially announced in October 2024, showed that VENT-03 was safe and well tolerated at all tested dose levels with a favorable PK profile enabling once-daily dosing. Article content 'We are pleased to present at LUPUS 2025 the first reported Phase 1 results for a cGAS inhibitor, demonstrating that VENT-03 has the potential to become a first- and best-in-class therapy for lupus and other autoimmune disorders,' said Marcelo Bigal, M.D., Ph.D., President and CEO of Ventus. 'Ventus is eager to unlock the potential of cGAS inhibition across multiple autoimmune diseases, with the first Phase 2 trial evaluating VENT-03 in patients with lupus to commence later this year.' Article content The Phase 1, double-blind, placebo-controlled, first-in-human trial included 72 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study results show that VENT-03 was safe and well tolerated up to single doses of 2000 mg once daily (QD) and multiple dosing of 900 mg QD for 10 days, which are substantially higher than our anticipated Phase 2 dose. The proportion of participants with adverse events (AEs) in the MAD cohorts was similar for VENT-03 and placebo (79% vs. 75%), and the vast majority of AEs in the study were mild and considered unrelated to the study drug. The PK profile of VENT-03 supports once-daily dosing with or without food, and the PD results demonstrate robust target engagement, supporting further clinical development. Article content 'More than five million people worldwide are estimated to have a form of lupus. These patients can experience disease progression and severe symptoms that can affect quality of life, and currently available treatment options may not be able to adequately address these symptoms for all patients,' said Mona Kotecha, M.D., Chief Medical Officer of Ventus. 'Through targeting cGAS, VENT-03 has the potential to become a safer and more effective treatment option for patients in need, addressing key unmet needs across multiple organ systems while providing the additional benefit of once-daily oral dosing. We look forward to sharing these results and to connecting with the wider lupus community at LUPUS 2025.' Article content Details of the poster presentation are as follows: Article content Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers of VENT-03, a Novel cGAS Inhibitor for the Treatment of Systemic Lupus Erythematosus Authors: Xavier Valencia, Kelly Pike, Loraine Warner, Conrad Winters, Jeanne Stewart, Ramsay Beveridge, Patrick Cyr, Nadine Fradet, Amandine Chefson, Ofer Spiegelstein Abstract Number: Poster 286 Session Date: May 22 nd Article content cGAS is an intracellular pattern recognition receptor that is activated after binding to double-stranded DNA (dsDNA) in the cytoplasm. The presence of dsDNA in the cytoplasm is often the result of cellular dysfunction, which is a hallmark of many autoimmune and inflammatory diseases. Activation of cGAS leads to cGAMP formation, activation of STING, pronounced inflammation, and tissue damage. In both patients and preclinical models of disease, the cGAS pathway has been shown to be a key driver of lupus and other inflammatory diseases, such as rheumatoid arthritis, systemic sclerosis, dermatomyositis, and Sjögren's disease. Article content Ventus Therapeutics is a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders. Using its proprietary drug discovery platform, ReSOLVE ®, the company has established a robust pipeline, including two wholly-owned programs. VENT-03 is a first-in-class, oral cGAS inhibitor expected to enter Phase 2 development for lupus in 2025. VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor in Phase 2 for Parkinson's disease, and is expected to enter Phase 2 development for osteoarthritis in obese patients later in 2025. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted, oral NLRP3 inhibitor in Phase 1, to Novo Nordisk A/S. For more information, please visit and engage with Ventus on LinkedIn. Article content Article content Article content Article content Article content Contacts Article content Media Dan Budwick 1AB dan@ Article content Article content
Business Wire
22-05-2025
- Business
- Business Wire
Ventus Therapeutics to Present Phase 1 Results for VENT-03, a First-in-Class cGAS Inhibitor, at LUPUS 2025
WALTHAM, Mass. & MONTREAL--(BUSINESS WIRE)-- Ventus Therapeutics, a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders, today announced the upcoming presentation of the Phase 1 safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) results of VENT-03 at the 16 th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), taking place from May 21-24 in Toronto, Canada. VENT-03 is the first oral small-molecule cyclic GMP-AMP synthase (cGAS) inhibitor to successfully complete a first-in-human Phase 1 study and was discovered using Ventus' proprietary ReSOLVE ® platform. Data from the Phase 1 study, initially announced in October 2024, showed that VENT-03 was safe and well tolerated at all tested dose levels with a favorable PK profile enabling once-daily dosing. 'We are pleased to present at LUPUS 2025 the first reported Phase 1 results for a cGAS inhibitor, demonstrating that VENT-03 has the potential to become a first- and best-in-class therapy for lupus and other autoimmune disorders,' said Marcelo Bigal, M.D., Ph.D., President and CEO of Ventus. 'Ventus is eager to unlock the potential of cGAS inhibition across multiple autoimmune diseases, with the first Phase 2 trial evaluating VENT-03 in patients with lupus to commence later this year.' The Phase 1, double-blind, placebo-controlled, first-in-human trial included 72 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study results show that VENT-03 was safe and well tolerated up to single doses of 2000 mg once daily (QD) and multiple dosing of 900 mg QD for 10 days, which are substantially higher than our anticipated Phase 2 dose. The proportion of participants with adverse events (AEs) in the MAD cohorts was similar for VENT-03 and placebo (79% vs. 75%), and the vast majority of AEs in the study were mild and considered unrelated to the study drug. The PK profile of VENT-03 supports once-daily dosing with or without food, and the PD results demonstrate robust target engagement, supporting further clinical development. 'More than five million people worldwide are estimated to have a form of lupus. These patients can experience disease progression and severe symptoms that can affect quality of life, and currently available treatment options may not be able to adequately address these symptoms for all patients,' said Mona Kotecha, M.D., Chief Medical Officer of Ventus. 'Through targeting cGAS, VENT-03 has the potential to become a safer and more effective treatment option for patients in need, addressing key unmet needs across multiple organ systems while providing the additional benefit of once-daily oral dosing. We look forward to sharing these results and to connecting with the wider lupus community at LUPUS 2025.' Details of the poster presentation are as follows: Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers of VENT-03, a Novel cGAS Inhibitor for the Treatment of Systemic Lupus Erythematosus Authors: Xavier Valencia, Kelly Pike, Loraine Warner, Conrad Winters, Jeanne Stewart, Ramsay Beveridge, Patrick Cyr, Nadine Fradet, Amandine Chefson, Ofer Spiegelstein Abstract Number: Poster 286 Session Date: May 22 nd About cGAS cGAS is an intracellular pattern recognition receptor that is activated after binding to double-stranded DNA (dsDNA) in the cytoplasm. The presence of dsDNA in the cytoplasm is often the result of cellular dysfunction, which is a hallmark of many autoimmune and inflammatory diseases. Activation of cGAS leads to cGAMP formation, activation of STING, pronounced inflammation, and tissue damage. In both patients and preclinical models of disease, the cGAS pathway has been shown to be a key driver of lupus and other inflammatory diseases, such as rheumatoid arthritis, systemic sclerosis, dermatomyositis, and Sjögren's disease. About Ventus Therapeutics Ventus Therapeutics is a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders. Using its proprietary drug discovery platform, ReSOLVE ®, the company has established a robust pipeline, including two wholly-owned programs. VENT-03 is a first-in-class, oral cGAS inhibitor expected to enter Phase 2 development for lupus in 2025. VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor in Phase 2 for Parkinson's disease, and is expected to enter Phase 2 development for osteoarthritis in obese patients later in 2025. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted, oral NLRP3 inhibitor in Phase 1, to Novo Nordisk A/S. For more information, please visit and engage with Ventus on LinkedIn.
National Post
29-04-2025
- Business
- National Post
Ventus Therapeutics to Present at 2025 Bloom Burton & Co. Healthcare Investor Conference
Article content WALTHAM, Mass. & MONTREAL — Ventus Therapeutics, a leading Phase 2 clinical-stage biopharmaceutical company advancing two novel small-molecule programs for immunological, inflammatory, and neurological disorders, today announced that its President and Chief Executive Officer, Marcelo Bigal, M.D., Ph.D., will present at the 2025 Bloom Burton & Co. Healthcare Investor Conference, being held May 5-6 in Toronto. Dr. Bigal will be presenting on Tuesday, May 6, at 1:30 p.m. ET. Article content Article content Ventus Therapeutics is a leading Phase 2 clinical-stage biopharmaceutical company advancing two novel small-molecule programs for immunological, inflammatory, and neurological disorders. Using its proprietary drug discovery platform, ReSOLVE ®, the company has established a robust pipeline, including two wholly-owned programs. VENT-03 is a first-in-class, oral cGAS inhibitor expected to enter Phase 2 development for lupus in 2025. VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor in Phase 2 for Parkinson's disease, and is expected to enter Phase 2 development for osteoarthritis in obese patients later in 2025. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted, oral NLRP3 inhibitor in Phase 1, to Novo Nordisk A/S. For more information, please visit and engage with Ventus on LinkedIn. Article content Article content Article content Article content Article content Contacts Article content Article content
Business Wire
29-04-2025
- Business
- Business Wire
Ventus Therapeutics to Present at 2025 Bloom Burton & Co. Healthcare Investor Conference
WALTHAM, Mass. & MONTREAL--(BUSINESS WIRE)-- Ventus Therapeutics, a leading Phase 2 clinical-stage biopharmaceutical company advancing two novel small-molecule programs for immunological, inflammatory, and neurological disorders, today announced that its President and Chief Executive Officer, Marcelo Bigal, M.D., Ph.D., will present at the 2025 Bloom Burton & Co. Healthcare Investor Conference, being held May 5-6 in Toronto. Dr. Bigal will be presenting on Tuesday, May 6, at 1:30 p.m. ET. About Ventus Therapeutics Ventus Therapeutics is a leading Phase 2 clinical-stage biopharmaceutical company advancing two novel small-molecule programs for immunological, inflammatory, and neurological disorders. Using its proprietary drug discovery platform, ReSOLVE ®, the company has established a robust pipeline, including two wholly-owned programs. VENT-03 is a first-in-class, oral cGAS inhibitor expected to enter Phase 2 development for lupus in 2025. VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor in Phase 2 for Parkinson's disease, and is expected to enter Phase 2 development for osteoarthritis in obese patients later in 2025. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted, oral NLRP3 inhibitor in Phase 1, to Novo Nordisk A/S. For more information, please visit and engage with Ventus on LinkedIn.
