| Item 7.01 |
Regulation FD Disclosure. |
On June 5, 2024, Ventyx Biosciences, Inc. (the “Company”), issued a press release announcing preclinical data regarding its CNS-penetrant NLRP3 inhibitor, VTX3232, in murine diet-induced obesity (“DIO”) models. The press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
| Item 8.01 |
Other Information. |
On June 5, 2024, the Company announced preclinical data regarding its CNS-penetrant NLRP3 inhibitor, VTX3232, in murine DIO models. Two separate 28-day studies were conducted with VTX3232 in DIO mice. In the first study (“DIO Study 1”), VTX3232 and semaglutide were evaluated as monotherapies compared to standard diet and DIO vehicle (high fat diet) controls. The second study (“DIO Study 2”) included an additional treatment group evaluating VTX3232 in combination with semaglutide. Key findings are summarized below.
DIO Study 1 (VTX3232 monotherapy):
| |
• |
|
Treatment with VTX3232 resulted in decreased body weight and food intake compared to DIO control. Reductions in liver steatosis and triglycerides were also observed. |
| |
• |
|
Improvements in cardiometabolic parameters were observed with VTX3232, including reductions in cholesterol, insulin resistance, fasting blood glucose and HbA1c. |
| |
• |
|
Systemic inflammatory biomarkers, including IL-1ß, IL-6, and fibrinogen, were reduced in the plasma of VTX3232-treated DIO mice. |
DIO Study 2 (VTX3232 in combination with semaglutide):
| |
• |
|
The combination of VTX3232 and semaglutide resulted in greater benefit on body weight, liver steatosis and metabolic parameters compared to VTX3232 or semaglutide alone. |
| |
• |
|
Systemic inflammatory biomarkers, including IL-1ß, IL-6, and fibrinogen, were further reduced in the combination arm relative to DIO mice dosed with VTX3232 or semaglutide alone. |
| |
• |
|
A trend towards improved body composition was observed with VTX3232 and semaglutide combination therapy, including a decrease in fat mass and a corresponding increase in lean mass as a percentage of total body weight. |
The Company expects to initiate a 28-day proof-of-concept Phase 2a trial of VTX3232 in participants with obesity and certain other cardiovascular risk factors during the second half of 2024, with topline results expected in the first half of 2025. In addition, the Company is planning a 12-week Phase 2 trial of VTX3232 in participants with obesity that is expected to initiate in the first half of 2025.
Forward Looking Statements
The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the Company’s plans to initiate Phase 2 trials of VTX3232 in participants with obesity and timing of topline results. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this presentation due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the results of preclinical studies and early clinical trials not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of clinical trials; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval