VERA THERAPEUTICS, INC. Item 7.01 Regulation FD Disclosure.
On
A copy of the presentation is furnished as Exhibit 99.1. For important information about forward-looking statements, see the slide titled "Forward-Looking Statements" in Exhibit 99.1 attached hereto.
The information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, 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 or Sections 11 and 12(a)(2) of the Securities Act of
1933, as amended. The information contained in this Item 7.01, including Exhibit
99.1, shall not be incorporated by reference into any filing with the
Item 8.01 Other Events.
As noted in Item 7.01, on
Figure 1. Patients Identified by Blinded Third-Party CRO and Excluded from Prespecified PP Analysis
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Atacicept is the Company's potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator and a proliferation-inducing ligand. ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACE or ARB therapy.
Prespecified Per-Protocol (PP) Analysis from the Phase 2b ORIGIN Clinical Trial
In the topline results published on
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In the PP analysis, at Week 24, the atacicept 150 mg dose group achieved a 41% mean reduction in proteinuria versus baseline and a 34% delta versus placebo (p=0.025). With interim data at Week 36, the atacicept 150 mg dose group achieved a 47% mean reduction in proteinuria from baseline and a 48% delta versus placebo, as shown in Figure 2. Data for the atacicept 150 mg dose group versus placebo from both the PP and ITT analyses can be referenced in Figure 3.
Figure 2. Prespecified PP Analysis: UPCR % Change In Atacicept 75 and 150 mg Through Week 36
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Figure 3. Summary of Positive Phase 2b Results (PP Analysis, ITT Analysis)
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Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, including a 1% discontinuation rate due to adverse events ("AEs") and comparable rates of infection compared to placebo. Serious treatment-emergent AEs were observed in 2% of patients in all atacicept arms and in 9% of patients in the placebo arm. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date - in which atacicept was well-tolerated.
Next Steps
The Company is continuing to rapidly advance atacicept into pivotal Phase 3
development, which is anticipated in the first half of 2023, subject to and
following discussions with the
Forward-looking Statements
Statements contained in this Current Report on Form 8-K regarding matters, events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform
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Act of 1995. Such forward-looking statements include statements regarding, among
other things, atacicept's potential to be a transformational treatment for
patients with IgAN and a best-in-class therapy, the Company's plans to advance
atacicept into pivotal Phase 3 development in the first half of 2023, and
regulatory matters, including the timing and likelihood of success in obtaining
drug approvals. Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or implied by such
forward-looking statements. Words such as "anticipate," "will," "potential,"
"plan," and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon the Company's
current expectations and involve assumptions that may never materialize or may
prove to be incorrect. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks related to the
regulatory approval process, results of earlier clinical trials may not be
obtained in later clinical trials, risks and uncertainties associated with the
Company's business in general, the impact of macroeconomic and geopolitical
events, including the COVID-19 pandemic, and the other risks described in the
Company's filings with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Slide presentation entitled "Origin Phase 2b Clinical Trial
Data Update".
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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