NGM Bio Announces Presentation of Post-Hoc Analyses from CATALINA Phase 2 Trial of NGM621 in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) at The Retina Society Annual Scientific Meeting
November 03 2022 - 1:00PM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today announced the
presentation of findings from post-hoc analyses of its randomized,
double-masked, sham-controlled CATALINA Phase 2 trial of NGM621, a
monoclonal antibody designed to inhibit activity of complement
component 3 (C3), in patients with GA secondary to AMD at The
Retina Society Annual Scientific Meeting taking place November 2 –
5, 2022 in Pasadena, Calif. The presentation, given by Charles C.
Wykoff, M.D., Ph.D., Director of Research at Retina Consultants
Texas and an investigator for the CATALINA trial, included a
summary of topline findings, as previously reported by NGM Bio, in
addition to results from post-hoc analyses undertaken to further
interpret the CATALINA study results. A recording of the
presentation given at the Retina Society meeting is available on
NGM Bio’s website at
https://www.ngmbio.com/discovery-engine/publications/.
The primary efficacy endpoint of the CATALINA trial was the rate
of change in GA lesion area (slope), as measured by fundus
autofluorescence (FAF) imaging, over 52 weeks of treatment. As
previously reported, over 52 weeks of treatment, NGM621
administered every four weeks (Q4W) (n=108) and every eight weeks
(Q8W) (n=104) via intravitreal injection demonstrated a reduction
in the rate of change in GA lesion area (slope) of 6.3% and 6.5%,
respectively, compared to sham (n=106), which did not reach
statistical significance in either arm.
“A closer, post-hoc look at the CATALINA data on a
patient-by-patient level suggests that complex, challenging GA
lesions coupled with apparent methodology limitations associated
with FAF grading may have led to unanticipated variability,”
commented Dr. Wykoff. “Post-hoc analyses that attempted to minimize
some of this variability have yielded encouraging findings that I
believe warrant further evaluation.”
One of the post-hoc analyses presented at the Retina Society
meeting involved the evaluation of a sub-population of patients
least likely to be impacted by FAF grading limitations: those in
the middle two quartiles of a quartile analysis based on baseline
lesion area. The patients in this sub-group had baseline GA lesions
measuring 4.17 – 9.64 mm2 as compared to study inclusion criteria
of baseline GA area between ≥2.5 mm2 and ≤17.5 mm2. In this
analysis, NGM621 demonstrated a reduction in the rate of change in
GA lesion area (slope) of 21.9% (Q4W) (n=55) and 16.8% (Q8W)
(n=52), compared to sham (n=53). Using MMRM analysis with the
adjusted treatment arm, the reduction in change from baseline in GA
at 52 weeks was 20.6% (Q4W) and 16.6.% (Q8W).
NGM621 was discovered by NGM Bio under its strategic
collaboration with Merck, known as MSD outside the United
States and Canada.
About NGM Bio
NGM Bio is focused on discovering and developing novel,
life-changing medicines for people whose health and lives have been
disrupted by disease. The company’s biology-centric drug discovery
approach aims
to seamlessly integrate interrogation of complex
disease-associated biology and protein engineering expertise to
unlock proprietary insights that are leveraged to generate
promising product candidates and enable their rapid advancement
into proof-of-concept studies. As explorers on the frontier of
life-changing science, NGM Bio aspires to operate one of the most
productive research and development engines in the
biopharmaceutical industry. All therapeutic candidates in the NGM
Bio pipeline have been generated by its in-house discovery engine,
always led by biology and motivated by unmet patient need. Today,
the company has seven programs in clinical
development, including four in Phase 2 or 2b
studies, including the recently completed NGM621 CATALINA
trial, across three therapeutic areas:
cancer, retinal diseases and liver and
metabolic diseases. Visit us at www.ngmbio.com for more
information.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as “will,” “may,” “believe,” “potential,”
“future,” “encouraging,” “promising,” “aspires,” “aims” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. These statements include those
related to: the potential for a future role for NGM621 to help
address the significant unmet need for GA patients; the observation
that challenging GA lesions coupled with potential methodology
limitations associated with FAF grading may have led to
unanticipated variability in the Phase 2 CATALINA results; the
belief that the findings from post-hoc analyses of the Phase 2
CATALINA findings warrant further evaluation; Merck’s decision, or
not, to exercise a one-time option to a worldwide, exclusive
license for NGM621 and its related compounds, either alone or
bundled with two additional undisclosed pre-clinical ophthalmology
compounds and their related compounds and the timing of any such
decision by Merck; a potential future NGM partner for NGM621; NGM
Bio’s aspiration to operate one of the most productive research and
development engines in the biopharmaceutical industry; and other
statements that are not historical fact. Because such statements
deal with future events and are based on NGM Bio’s current
expectations, they are subject to various risks and uncertainties,
and actual results, performance or achievements of NGM Bio could
differ materially from those described in or implied by the
statements in this press release. These forward-looking statements
are subject to risks and uncertainties, including, without
limitation, risks and uncertainties associated with the costly and
time-consuming pharmaceutical product development process and the
uncertainty of clinical success, including the risk that NGM621 may
be unable to demonstrate future clinical benefit in patients with
GA, particularly in light of the failure to achieve the primary
endpoint in the Phase 2 CATALINA study of NGM621; risks related to
failure or delays in successfully initiating, enrolling, reporting
data from or completing clinical studies, as well as the risks that
results obtained in preclinical or clinical trials to date may not
be indicative of results obtained in future trials and that
post-hoc analyses performed after unmasking trial results, such as
the Phase 2 CATALINA results, can result in the introduction of
bias, have other limitations and may not be predictive of results
obtained in future trials; NGM Bio’s reliance on its amended
collaboration with Merck, including the risks that if Merck fails
to exercise its option to license NGM621, NGM Bio would need to
partner the NGM621 program in order to further clinical development
of NGM621, if any, which NGM Bio may be unable to do in a timely
manner or at all, which could delay or preclude the further
development of and/or commercialization of NGM621 in which case,
NGM may not receive any return on its investment in NGM621; the
ongoing COVID-19 pandemic, which has adversely affected, and could
materially and adversely affect in the future, NGM Bio’s business
and operations, including NGM Bio’s ability to timely supply,
initiate, enroll and complete its ongoing and future clinical
trials of its other product candidates; the time-consuming and
uncertain regulatory approval process; NGM Bio’s reliance on
third-party manufacturers for its product candidates and the risks
inherent in manufacturing and testing pharmaceutical products; the
sufficiency of NGM Bio’s cash resources and NGM Bio’s need for
additional capital; and other risks and uncertainties affecting NGM
Bio and its development programs, including those discussed in the
section titled “Risk Factors” in NGM Bio’s quarterly report on Form
10-Q for the quarter ended June 30, 2022 filed with the Securities
and Exchange Commission (SEC) on August 4, 2022 and future filings
and reports that NGM Bio makes from time to time with the SEC.
Except as required by law, NGM Bio assumes no obligation to update
these forward-looking statements, or to update the reasons if
actual results differ materially from those anticipated in the
forward-looking statements.
Investor Contact:Brian
Schoelkopfir@ngmbio.com |
Media
Contact:Liz Melonemedia@ngmbio.com |
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