Item 8.01. Other Events.
Phase 1/2 Clinical Trial of EDP1503 in Combination with Pembrolizumab
On
Interim Safety Results - As of the cutoff date, the combination of EDP1503 and pembrolizumab was generally well-tolerated with the majority of treatment-related adverse events ("AEs") reported by investigators being Grade 1 or 2. Across all grades, treatment-related AEs reported by investigators most commonly included abdominal distension (20%), decreased appetite (20%), diarrhea (13%), flatulence (13%), nausea (13%), pruritis (13%) and rash maculo-papular (13%). Investigators reported a single treatment-related Grade 3 AE in one patient (diarrhea). No treatment-related Grade 4 or 5 AEs or serious AEs were reported, and one patient discontinued EDP1503 due to a treatment-related AE.
Interim Efficacy Results - Fifteen patients were evaluable for response assessment as of the cutoff date, as measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Among all 15 patients treated, the overall response rate ("ORR") was 13 percent, and the disease control rate ("DCR") was 20 percent. In patients receiving high dose EDP1503 therapy, the ORR was 17 percent and the DCR was 25 percent, with partial responses observed in two patients and stable disease observed in one patient. One patient who had relapsed on prior therapy with an anti-PD-L1 inhibitor combination had a partial response to the EDP1503 and pembrolizumab combination treatment. The patient was on treatment for 10.5 months and had no measurable disease visible on their latest PET scan as of the data cutoff date.
Prioritization of EDP1908
The Company previously announced preclinical data for EDP1908, its bacterial
extracellular vesicle (EV) product candidate for the treatment of cancer, were
presented at the
The data also demonstrated that treatment with EDP1908 activated IFN?-positive cytolytic and helper lymphocytes, dendritic cells, and interferon gamma-induced protein 10 (IP-10) in the tumor microenvironment. Fluorescent biodistribution analysis showed that EDP1908 was not detected outside the gastrointestinal tract. These data suggest that EDP1908 activated innate immunity locally on host immune cells in the gut and triggered distal immune responses within the tumor microenvironment, with no apparent adverse safety or tolerability issues.
Following a comprehensive assessment of the EDP1503 data and informed by the foregoing, the Company has determined to prioritize the development of EDP1908 as its lead clinical candidate in oncology given its superior preclinical activity over EDP1503. The Company is scaling up manufacturing in order to advance EDP1908 into the clinic in the first half of 2022. The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study.
Positive Topline Clinical Data in Phase 1b Trial of EDP1815 in Atopic Dermatitis
On
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Secondary Endpoints - Secondary endpoints included a range of established
markers of clinical efficacy in atopic dermatitis, such as the percentage change
in Eczema Area and Severity Index ("EASI") score, which is the most common tool
used to measure extent and severity of atopic eczema, and the percentage change
in Investigator's Global Assessment and Body Surface Area ("IGA* BSA"). Clinical
differences between EDP1815 and placebo for evaluable subjects were
statistically significant at day 56 in both the percentage change in
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
to moderate atopic dermatitis, randomized 2:1 to receive oral administration of
the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days.
As of
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 press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements concerning the development of EDP1908 and EDP1815, the promise and potential impact of EDP1908 and the Company's other product candidates, the timing of and plans for clinical trials of EDP1908, and the future results for the Phase 1b clinical trial 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
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