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
Topline results from the Phase 2b ORIGIN clinical trial
The primary endpoint analysis, change in proteinuria as evaluated by urine protein creatinine ratio ("UPCR") at week 24 of the pooled 75/150 mg dose groups, achieved statistical significance and showed a 31% mean reduction versus baseline (p=0.037 versus placebo). Statistical significance was also achieved in the individual 150 mg dose group with a 33% mean reduction in proteinuria versus baseline (p=0.047 versus placebo) and the all-atacicept group versus placebo, as shown in Figure 1.
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Figure 1. UPCR-24h % Change at Week 24
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A trend towards further reductions in proteinuria was observed in the all-atacicept group versus placebo with 38% of patient data available at Week 36, as shown in Figure 2.
Figure 2. UPCR-24h % Change through Week 36
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The exploratory endpoint analysis, change in estimated glomerular filtration rate ("eGFR"), showed stabilization in the all-atacicept group through Week 24, as shown in Figure 3.
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Figure 3. eGFR Change through Week 24
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Atacicept robustly reduced galactose-deficient IgA1 ("Gd-IgA1") from baseline through 24 weeks, as shown in Figure 4.
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Figure 4. Gd-IgA1 % Change through Week 24 [[Image Removed: LOGO]]
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
As a result of these positive data, the Company plans to advance atacicept into
pivotal Phase 3 development 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 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 "could," "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
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Slide presentation entitled "Origin Phase 2b Clinical Trial
Week 24 Results".
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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