7.01 Regulation FD Disclosure.
On November 30, 2020, Allena Pharmaceuticals, Inc. (“Allena” or the “Company”) issued a press release announcing clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. A copy of the press release is attached as Exhibit 99.1 hereto.
Additionally, the Company made available an updated copy of its Corporate Presentation on the Investor Relations section of the Company’s website. The Corporate Presentation may be used at investor and other meetings. The Company does not intend to incorporate any contents from its website into this Form 8-K.
The information in this Item 7.01 of Form 8-K, including the accompanying Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On November 30, 2020, the Company announced initial data from its Phase 1 Clinical Trial for ALLN-346. The double-blind, placebo-controlled, single-ascending dose study enrolled 24 healthy volunteers. Groups of eight study participants were randomized 3:1 to ALLN-346 or matching placebo in three sequential cohorts dosed orally with three, six, or 12 capsules in one day. Each capsule of ALLN-346 contained a target dose of 90 mg of enzyme, equivalent to 2,250 units. ALLN-346 was well-tolerated with no clinically significant safety signals and no dose-limiting toxicities observed in any cohort up to the highest administered dose. In addition, assay of serum samples by ELISA immunoassay demonstrated that ALLN-346 was not absorbed systemically, supporting that its mechanism of action appears to be restricted to the GI tract.
Subject to feedback from the U.S. Food and Drug Administration, the Company expects to initiate a Phase 1b multiple-ascending dose trial in healthy volunteers and a Phase 2 proof-of-concept trial in patients with hyperuricemia and CKD in the first half of 2021, with initial data from both studies expected in the second half of 2021.
Forward-Looking Statements
This Current Report on Form 8-K (this “Current Report”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the clinical data from Allena’s Phase 1 trial of ALLN-346; Allena’s future development plans for ALLN-346; Allena’s pipeline of oral enzyme therapeutic candidates and Allena’s plans to build a commercial organization. Any forward-looking statements in this Current Report are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Item 1A of Part I of Allena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this Current Report is as of the date hereof and Allena undertakes no duty to update this information unless required by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
