Skylight Health Group Inc (TSXV:SHG; OTCQX: SHGFD) (“Skylight
Health” or the “Company”), a multi-state primary care management
group in the United States, announced today that they have signed a
contract with Adagio Therapeutics, Inc. (“Adagio”) to enroll
patients into the Phase 2/3 trial (EVADE) evaluating Adagio’s
monoclonal antibody, ADG20, designed to be a potent, long-acting
and broadly neutralizing antibody for both the treatment and
prevention of COVID-19.
Skylight Health’s clinic in Burlington, MA will enroll both
existing Skylight Health patients as well as individuals from the
general population. The trial itself is a randomized, double-blind,
placebo-controlled trial, meaning that participants will have a
50/50 chance of receiving either the monoclonal antibody, ADG20, or
a placebo. Seeking to determine if ADG20, compared to a placebo, is
safe and efficacious in preventing symptomatic COVID-19, the trial
seeks to enroll two separate populations: (1) individuals with
known exposure to a person with laboratory-confirmed SARS-CoV-2
infection (post-exposure); and (2) individuals who are at increased
risk for SARS-CoV-2 infection (pre-exposure). The trial population
also includes individuals at risk of generating poor vaccine
response, such as those who are immunocompromised. The primary
endpoint is the proportion of participants with
laboratory-confirmed symptomatic COVID-19 through Day 28 for the
post-exposure cohort and through six months for the pre-exposure
cohort. Participants will be followed for 12 months following
receipt of the trial product (ADG20 or placebo). Approximately 100
clinics sites will participate internationally to enroll 6,400
participants for the EVADE trial.
“We are incredibly excited to have the opportunity to partner
with Adagio on this important initiative. Skylight Health is
dedicated to contributing to the advancement of medical science and
participating in clinical trials as a recruiting site to provide
the opportunity for patients to access ground-breaking treatments
and preventative measures. This trial comes at a pivotal moment in
the fight against the COVID-19 pandemic while SARS-CoV-2 variants
are on the rise and vaccine supply and acceptance struggles
continue worldwide,” said Alisha Garibaldi, Clinical Research
Manager.
Skylight Health will be responsible for consenting, enrolling,
administering the investigational product (or placebo), and
following trial participants while monitoring for safety and the
onset of any COVID-19-like symptoms.
Skylight Health will be compensated for all trial-related
activities as part of the agreement with Adagio, with compensation
tied directly to successfully enrolling and following research
participants. Participants are also compensated for their time in
the trial.
About Adagio Therapeutics
Adagio is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of antibody-based
solutions for infectious diseases with pandemic potential. Their
candidates are engineered using best-in-industry antibody discovery
capabilities and are designed to maximize potency and duration of
effect. Adagio is developing its lead product candidate, ADG20, for
the treatment and prevention of coronavirus disease 2019, or
COVID-19, the disease caused by the virus SARS-CoV-2 and its
variants. Adagio aims to address COVID-19 and future potential
viral outbreaks by building a portfolio of antibodies with broadly
neutralizing activity against multiple members of the coronavirus
family or additional viruses with pandemic potential. Pre-clinical
data show that their lead product candidate, ADG20, has
demonstrated potent neutralizing activity against SARS-CoV-2 and
the emerging variants that have been associated with lower efficacy
rates of certain vaccines and that are resistant or partially
resistant to a subset of currently available or clinical-stage
monoclonal antibody programs. They plan to advance ADG20 through
global clinical trials for both the treatment and prevention of
COVID-19. Beyond ADG20, Adagio’s portfolio of SARS-CoV-2 antibodies
target distinct viral epitopes from that of ADG20 and are being
developed for potential use as combination therapies. For more
information: www.adagiotx.com
About Skylight Health Group Inc.
Skylight Health Group (TSXV:SHG; OTCQX:SHGFF) is a healthcare
services and technology company, working to positively impact
patient health outcomes. The Company operates a US multi-state
primary care health network comprised of physical practices
providing a range of services from primary care, sub-specialty,
allied health, and laboratory/diagnostic testing. The Company is
focused on helping small and independent practices shift from a
traditional fee-for-service (FFS) model to value-based care (VBC)
through tools including proprietary technology, data analytics and
infrastructure. In a FFS model, payors (commercial and government
insurers) reimburse on an encounter-based approach. This puts a
focus on volume of patients per day. In a VBC model, payors
reimburse typically on a capitation (fixed fee per member per
month) basis. This places an emphasis on quality over volume. VBC
will lead to improved patient outcomes, reduced cost of delivery
and drive stronger financial performance from existing
practices.
For more information, please visit www.skylighthealthgroup.com
or contact:
Investor Relations:
Jackie
Kelly investors@skylighthealthgroup.com 416-301-2949
John Evansjohn.evans@skylighthealthgroup.com415-309-0230
Currency Usage, Cautionary and Forward-Looking
Statements
Any currency measure found within this release is stated in
Canadian Dollars unless otherwise stated.
Statements in this news release that are forward-looking
statements are subject to various risks and uncertainties
concerning the specific factors disclosed here and elsewhere in
Skylight Health's filings with Canadian securities regulators. When
used in this news release, words such as "will, could, plan,
estimate, expect, intend, may, potential, believe, should," and
similar expressions, are forward-looking statements.
Forward-looking statements may include, without limitation,
statements regarding the Company's unaudited financial results and
projected growth.
Although Skylight Health has attempted to identify important
factors that could cause actual results, performance or
achievements to differ materially from those contained in the
forward-looking statements, there can be other factors that cause
results, performance or achievements not to be as anticipated,
estimated or intended, including, but not limited to: the ability
of Skylight Health to execute on its business strategy, continued
revenue growth in accordance with management’s expectations,
operating expenses continuing in accordance with management
expectations, dependence on obtaining regulatory approvals;
Skylight Health being able to find, complete and effectively
integrate target acquisitions; change in laws relating to health
care regulation; reliance on management; requirements for
additional financing; competition; hindering market growth or other
factors that may not currently be known by the Company.
There can be no assurance that such information will prove to be
accurate or that management's expectations or estimates of future
developments, circumstances or results will materialize. As a
result of these risks and uncertainties, the results or events
predicted in these forward-looking statements may differ materially
from actual results or events.
Accordingly, readers should not place undue reliance on
forward-looking statements. The forward-looking statements in this
news release are made as of the date of this release. Skylight
Health disclaims any intention or obligation to update or revise
such information, except as required by applicable law, and
Skylight Health does not assume any liability for disclosure
relating to any other company mentioned herein.
Neither the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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