Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

"Clinical trials drive new, innovative tools to fight diseases, and overcoming barriers to access to clinical trials for under-represented communities is critical to improving health equity," said Andrea Wainer , executive vice president, Rapid and Molecular Diagnostics, and co-executive sponsor for the company's Diversity in Clinical Trials steering committee alongside Lisa Earnhardt , executive vice president of Medical Devices at Abbott. "Abbott has been focused on breaking down barriers and implementing new, sustainable partnerships and programs to drive even more diversity in our clinical trials and to ensure trials are offered in more places to reach underserved areas."

Improving Access Through New Clinical Research Models
Through a new five-year commitment, Abbott will work alongside the Institute for Health Equity at Norton Healthcare to build research program models that can be implemented by historically black colleges and universities (HBCUs) and clinics serving under-represented communities so they don't need to design and develop their own research programs from the ground up, which can be expensive and resource intensive.

Within the program, Abbott and Norton Healthcare will provide a roadmap of best practices to help community-based clinics create clinical trial research centers of excellence. The initiative will also provide grants to support the hiring and training of research coordinators and data managers and help guide the launch of research programs. Alongside building sustainable research programs, the effort aims to increase the number of trial sites that can reach underserved populations to reduce barriers to clinical trials.

The first pilot project stemming from the new grant will work to better connect more people from underrepresented communities to clinical trials. The first project will develop a new research center in Louisville, Ky. , focused on helping more African American patients access clinical trial opportunities. The project will specifically support patients in historically redlined areas of Louisville . "Redlining" is a discriminatory practice of withholding services from neighborhoods with significant numbers of racial and ethnic minorities and low-income residents. As a result, those communities have had reduced access to health services, including clinical research opportunities.

"As we focus on improving access to innovative health care options for patients who have been historically under-represented in clinical research, developing new models for research centers that can be implemented within rural or urban community clinics can have a profound impact on improving access to clinical trials for these patients," said Kelly McCants , M.D., a heart failure cardiologist and executive director of the Norton Heart & Vascular Institute Advanced Heart Failure & Recovery Program, who will help launch one of the pilot programs.

Expanding the Pool of Diverse Clinical Research Coordinators
Clinical research coordinators within healthcare clinics, doctor's offices and hospitals are essential to the success of clinical trials. They are key to improving the diversity of clinical trials because they serve as a central point of contact for patients, their families and the investigating physician leading the clinical trial. Through a partnership with Barnett International, Abbott is providing a comprehensive education program to support the training of new coordinators who are from diverse backgrounds and who will work with under-represented communities.

Upon completion of this course, participants will have a strong foundation in essential core areas of conducting clinical research. This includes training on study execution, the patient consent process, Good Clinical Practice guidelines, source documentation requirements and other regulatory required procedures. Offering training to clinical research coordinators with diverse backgrounds will address another key barrier for potential study participants.

New Diversity in Research Office within Abbott
Alongside new external partnerships and programs, the company has established a Diversity in Research Office to further Abbott's focus on driving diversity in the company's clinical trials and improving access to care among under-represented populations.

The new Diversity in Research Office will be led by Jennifer Jones-McMeans , Ph.D., divisional vice president of global clinical affairs for Abbott's vascular business, and Aparna Ahuja , M.D., divisional vice president for medical, clinical, and scientific affairs, Infectious Disease, for Abbott's rapid diagnostics business. The office will be responsible for ensuring that research efforts include diversity plans, key performance goals and foster collaboration across Abbott, the industry and regulatory bodies.

"Ensuring that clinical trials are as diverse as the people a product intends to serve is critically important in providing the best health care, so we're developing programs to address as many barriers as possible," said Jones-McMeans. "At Abbott, we've implemented programs that will increase the diversity of trials, including assessing how we conduct our own trials to make sure that we're doing all we can do to increase diversity in our clinical trials by increasing participation from under-served and under-represented populations."

Building Sustainable Change
Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation.

In the first year of the program, Abbott established a Diversity in Clinical Trials Medical Advisory Board comprised of external experts, an internal steering committee and has focused on increasing diversity enrollment in the company's own clinical trials. Through $5 million in grants, the company also sponsored more than 300 scholarships at the four HBCU medical schools and the National Black Nurses Association and National Association of Hispanic Nurses to support future leaders of clinical research.

To learn more about Abbott's Diversity in Research Initiative, visit https://www.abbott.com/diversity-in-clinical-trials.html .

Innovating for Greater Access and Equity in Health
Abbott's work to drive diversity in medical research is one example of the company innovating for greater access and affordability in health, the key priority of Abbott's 2030 Sustainability Plan . Abbott's ongoing commitment to address health equity challenges also includes targeted programs to create opportunities in STEM for women and underrepresented groups, build a more diverse healthcare supply chain and empower communities to break down social and economic barriers to better health.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at https://www.facebook.com/Abbott and on Twitter @AbbottNews .

View original content: https://www.prnewswire.com/news-releases/abbott-announces-new-partnerships-and-programs-to-advance-its-diversity-in-clinical-trials-initiative-301821930.html

SOURCE Abbott

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The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
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agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
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HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.¹ In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD².
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.³
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR₄
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR₁₂) are considered cured of
hepatitis C
About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR₁₂.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
¹ Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
² IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
³ American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
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