AsiaNet  85802

WALTHAM, Mass. and FLORENCE, Italy, Sept. 25, 2020/PRNewswire=KYODO JBN/--

Target enrollment milestone reached in the Phase 3 EMERALD study

Life cycle planning advancing in parallel with current Phase 3 monotherapy

program

Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS) and the Menarini

Group today announced an update on the elacestrant Phase 3 EMERALD trial.

EMERALD Phase 3 Study

The target enrollment milestone has been reached in the Phase 3 EMERALD

clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen

Receptor Degrader (SERD) that is being studied in postmenopausal women and men

with ER+/HER2- advanced or metastatic breast cancer. The study reached its

enrollment goal of 466 patients overall, including 220 (47%) with tumors

harboring an ESR1 mutation as detected in circulating tumor DNA by the Guardant

Health Guardant360 liquid biopsy test.

Patients will be followed until the required number of events to assess

progression-free survival - the primary endpoint of the study - is reached at

which time the primary analysis will be performed.  It is anticipated that this

analysis will take place in the second half of 2021.

An independent data monitoring committee (IDMC) has been continuously

monitoring the safety and efficacy of patients enrolled in the EMERALD trial.

After enrollment of 70% of planned patients, the committee formally reviewed

results of a futility analysis. In completing their review, the IDMC

recommended that the trial continues to advance in an unmodified manner.

"We are thrilled about the continued progress for the program. Elacestrant

continues to be the most advanced oral SERD in Phase 3 development and given

that, we aim on being first to deliver Phase 3 data in the class, and upon

clinical success, a regulatory submission," said Elcin Barker Ergun, Chief

Executive Officer of the Menarini Group.

Commenting further, Barker Ergun added that "the Menarini/Radius partnership

has been a tremendous success to date and the completion of patient enrollment

in the EMERALD trial brings us one step closer to bringing an oral SERD to

women and men with advanced breast cancer."

Dr. Maureen Conlan, Oncology Therapeutic Area Head for Radius, commented

"Completing the enrollment of the EMERALD trial, despite the challenges of the

COVID-19 pandemic, has been a great achievement. I am grateful to our team as

well as the study investigators and patients for their efforts to date in

supporting and participating in this trial."

In summarizing on recent progress, Dr. Charles Morris, Chief Medical Officer

for Radius added "This is an exciting milestone for Radius and our partner, the

Menarini Group, with regard to the elacestrant program. We look forward to

seeing additional advancement of the program including activities related to

various life cycle management opportunities for the compound."

About Menarini Group

Menarini Group is a leading international pharmaceutical company with a

presence in 140 countries, including a direct presence in over 70 countries.

Its global platform extends throughout Europe, U.S., Central America, Africa,

the Middle East and Asia Pacific, and generates over $4.2 billion in annual

sales. Menarini is committed to oncology, with an already commercialized

product in the US and several new investigational drugs in development for the

treatment of a variety of tumors. For over 130 years, Menarini has also been

investing in the development, production and distribution of pharmaceuticals to

serve patients and physicians around the world with a full portfolio of

products covering a number of different therapeutic areas.

About Radius

Radius is a science-driven fully integrated biopharmaceutical company that is

committed to developing and commercializing innovative endocrine therapeutics.

For more information, please visit www.radiuspharm.com

About elacestrant (RAD1901) and EMERALD Phase 3 Study

Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to

Menarini Group, which is being evaluated for potential use as a once daily oral

treatment in patients with ER+/ HER2- advanced breast cancer. Studies completed

to date indicate that the compound has the potential for use as a single agent

or in combination with other therapies for the treatment of breast cancer. The

EMERALD Phase 3 trial is a randomized, open label, active-controlled study

evaluating elacestrant as second- or third-line monotherapy in ER+/HER2-

advanced/metastatic breast cancer patients. The study has enrolled 466 patients

who have received prior treatment with one or two lines of endocrine therapy,

including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study

were randomized to receive either elacestrant or the investigator's choice of

an approved hormonal agent. The primary endpoint of the study is

progression-free survival (PFS) in the overall patient population and in

patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints

include evaluation of overall survival (OS), objective response rate (ORR), and

duration of response (DOR).

Forward-Looking Statements            

This press release 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.

These forward-looking statements are based on management's current

expectations. These statements involve known and unknown risks and

uncertainties that may cause our actual results, performance or achievements to

be materially different from any expressed or implied by the forward-looking

statements. These risks include, but are not limited to, risks related to

elacestrant's development and, if approved, commercialization, including the

impact of the COVID-19 pandemic thereon. These and other important risks and

uncertainties discussed in our filings with the Securities and Exchange

Commission, or SEC, including under the caption "Risk Factors" in our Annual

Report on Form 10-K for the year ending December 31, 2019 and subsequent

filings with the SEC, could cause actual results to differ materially from

those indicated by the forward-looking statements made in this press release.  

While we may elect to update such forward-looking statements at some point in

the future, we disclaim any obligation to do so, even if subsequent events

cause our views to change.  These forward-looking statements should not be

relied upon as representing our views as of any date subsequent to the date of

this press release.

Translations: in the event of any discrepancy, the English language version

prevails

Logo: https://mma.prnewswire.com/media/652491/MENARINI_Group_Logo.jpg

SOURCE: Menarini I.F.R.