Ventyx Biosciences, Inc., a biopharmaceutical company specializing in the development of novel oral therapies for inflammatory diseases, has announced its financial results for the first quarter ending March 31, 2024. The company, headquartered in San Diego, remains focused on addressing significant unmet medical needs in the realm of inflammatory and autoimmune disorders.
Raju Mohan, Chief Executive Officer of Ventyx, expressed optimism about the progress of their portfolio, particularly their oral NLRP3 inhibitors. The company is preparing to advance these inhibitors into Phase 2 trials for conditions with high unmet medical needs. Mohan also highlighted the anticipation around their TYK2 inhibitor VTX958 for Crohn's disease, with topline Phase 2 data expected in the early second half of the year.
Ventyx’s financial position remains strong with $302.6 million in cash, cash equivalents, and marketable securities as of March 31, 2024. This financial foundation is expected to support planned operations well into the second half of 2026. The first quarter of 2024 saw research and development (R&D) expenses of $33.7 million, slightly lower than the $35.4 million in the same period of the previous year. General and administrative expenses were $8.0 million, up from $7.1 million in the first quarter of 2023. The net loss for the quarter stood at $38.6 million, marginally less than the $38.9 million loss recorded in the first quarter of 2023.
Pipeline updates from Ventyx include significant advancements:
1. VTX3232 (CNS-penetrant NLRP3 Inhibitor):
- Positive results were reported from a Phase 1 trial, showcasing VTX3232’s dose-dependent pharmacokinetic and pharmacodynamic profiles.
- The inhibitor demonstrated robust effects on biomarkers in both plasma and cerebrospinal fluid (CSF) without dose-limiting toxicities.
- Phase 2a trials are planned for the second half of 2024, targeting patients with early Parkinson’s disease and participants with obesity and cardiovascular risk factors.
2. VTX2735 (Peripheral NLRP3 Inhibitor):
- A Phase 2 proof of concept trial in patients with cryopyrin-associated periodic syndromes (CAPS) showed an 85% reduction in the Key Symptom Score and significant improvements in inflammatory biomarkers.
- VTX2735 was well-tolerated with mild adverse events and future development will focus on cardiovascular diseases, particularly the secondary prevention of major adverse cardiovascular events (MACE) and recurrent pericarditis.
3. VTX002 (S1P1R Modulator):
- Positive results from a Phase 2 trial in patients with ulcerative colitis (UC) highlighted VTX002’s potential as a best-in-disease oral agent.
- Following a successful End of Phase 2 meeting with the U.S. FDA, plans are underway for a pivotal Phase 3 trial.
- A Scientific Advice meeting with the European Medicines Agency (EMA) is anticipated in the second quarter of this year.
4. VTX958 (TYK2 Inhibitor):
- VTX958 is under evaluation in a Phase 2 trial for Crohn’s disease, with a streamlined trial design to expedite efficacy signal detection.
- Enrollment for the trial has been completed, and topline results are expected early in the second half of 2024.
Ventyx’s strategy includes identifying partners or non-dilutive financing sources to support the pivotal Phase 3 trials of VTX002 in UC. Overall, Ventyx aims to shift the inflammation and immunology markets from injectable to oral drugs through its innovative pipeline, positioning itself as a leader in developing oral therapies for peripheral and neuroinflammatory diseases.
The company will host a conference call to discuss its financial results and provide a corporate update, reflecting its continued commitment to advancing its therapeutic candidates and meeting unmet medical needs.
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