UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| |
||
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On January 3, 2023, Vera Therapeutics, Inc. (the “Company”) announced positive topline results from the Company’s Phase 2b ORIGIN clinical trial evaluating its product candidate atacicept in patients with immunoglobulin A nephropathy (“IgAN”). In connection with the data release, the Company compiled a presentation entitled “Origin Phase 2b Study Week 24 Results”, which includes atacicept clinical summary results to date, including the data from the Phase 2b ORIGIN clinical trial referenced above. The Company will host a conference call and webcast with such presentation at 8:00 a.m. ET on January 4, 2023. The live webcast will be available on the Events & Presentations page of the Company’s website, with the recording and presentation available immediately following the event.
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 U.S. Securities and Exchange Commission (“SEC”) made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
As noted in Item 7.01, on January 3, 2023, the Company announced positive topline data from its Phase 2b ORIGIN clinical trial of atacicept in patients with IgAN. 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 (n=116) 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.
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.
Figure 1. UPCR-24h % Change at Week 24
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
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.
Figure 3. eGFR Change through Week 24
Atacicept robustly reduced galactose-deficient IgA1 (“Gd-IgA1”) from baseline through 24 weeks, as shown in Figure 4.
Figure 4. Gd-IgA1 % Change through Week 24
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 U.S. Food and Drug Administration. The full data sets from the ORIGIN clinical trial will be presented at a future medical meeting.
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 SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Vera Therapeutics, Inc. | ||||||
| Dated: January 3, 2023 | ||||||
| By: | /s/ Marshall Fordyce, M.D. | |||||
| Marshall Fordyce, M.D. | ||||||
| Chief Executive Officer | ||||||