Item 8.01. Other Events.
Updated Data from Phase 1b Trial of 1815
On
Treatment with EDP1815 resulted in clinically meaningful improvement in the Dermatology Life Quality Index ("DLQI") and Patient-Oriented Eczema Measure (POEM). These patient-reported outcomes capture the important impact of the disease on patients, including the domains of itch and sleep, both of which saw improvements in patients receiving EDP1815 in the study. All five measures of itch within the Pruritus-Numerical Rating Scale (Pruritus-NRS), SCORing Atopic Dermatitis ("SCORAD"), POEM, and DLQI showed greater improvements in the treated group at day 56 compared with placebo.
The full results also reinforce the positive interim data released on
Table 1 Clinical Measure Treatment Difference between EDP1815 and Placebo Percentage Change at Day 56*EASI 52% (p=0.062) IGA*BSA 65% (p=0.022) SCORAD 55% (p=0.043)
*Least Squares Mean Percentage Change From Baseline
Although this Phase 1b study was not powered to evaluate statistical
significance on efficacy measures, the data showed consistent improvements in
percentage change from baseline compared to placebo for all three clinical
scores:
About the EDP1815 Phase 1b Clinical Trial - EDP1815-101 is a double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety and tolerability of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis. The atopic dermatitis cohort enrolled 24 patients with mild and moderate atopic dermatitis, randomized 2:1 to receive oral administration of the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days, with follow-up off treatment at day 70. Patients were not allowed to use active topical treatments and were not required to use emollients. The primary endpoint was safety and tolerability. Secondary endpoints included a range of established markers of atopic dermatitis.
Corporate Slide Presentation
On
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Forward-Looking Statements
This Current Report on Form 8-K (the "Current Report") contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements concerning the development of EDP1815, the promise and potential impact of EDP1815 and the Company's other product candidates, and the timing of and plans for future clinical trials of EDP1815.
These forward-looking statements are based on management's current expectations.
These statements are neither promises nor guarantees, but involve known and
unknown risks, uncertainties and other important factors that may cause the
Company's actual results, performance or achievements to be materially different
from any future results, performance or achievements expressed or implied by the
forward-looking statements, including, but not limited to, the following: the
impact of the COVID-19 pandemic on the Company's operations, including the
Company's preclinical studies and clinical trials, and the continuity of the
Company's business; the Company has incurred significant losses, is not
currently profitable and may never become profitable; the Company's need for
additional funding; the Company's limited operating history; the Company's
unproven approach to therapeutic intervention; the lengthy, expensive, and
uncertain process of clinical drug development, including potential delays in
regulatory approval; the Company's reliance on third parties and collaborators
to expand its microbial library, conduct its clinical trials, manufacture its
product candidates, and develop and commercialize its product candidates, if
approved; the Company's lack of experience in manufacturing, selling, marketing,
and distributing its product candidates; failure to compete successfully against
other drug companies; protection of the Company's proprietary technology and the
confidentiality of its trade secrets; potential lawsuits for, or claims of,
infringement of third-party intellectual property or challenges to the ownership
of its intellectual property; the Company's patents being found invalid or
unenforceable; risks associated with international operations; the Company's
ability to retain key personnel and to manage its growth; the potential
volatility of the Company's common stock; the Company's management and principal
stockholders have the ability to control or significantly influence its
business; costs and resources of operating as a public company; unfavorable or
no analyst research or reports; and securities class action litigation against
the Company. These and other important factors discussed under the caption "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the quarterly period
ended
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Corporate Slide Presentation, d ated January 20, 2021. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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