AsiaNet 88122

TEL AVIV, Israel and RALEIGH, N.C., Feb. 17, 2021 /PRNewswire=KYODO JBN/ --

- The U.S. Phase 2/3 study with once-daily, orally-administered RHB-107

(upamostat) evaluates treatment of patients with symptomatic COVID-19 who do

not require hospitalization - the vast majority of patients

- RHB-107 is a novel serine protease inhibitor targeting human cell factors

involved in viral entry, and is therefore expected to be effective against

emerging viral variants with mutations in the spike protein

- The RHB-107 Phase 2/3 study allows patients to remain in the comfort of their

home while being monitored at a level previously possible only in a hospital

setting

- In parallel, top-line data from global Phase 2/3 study in hospitalized

patients with opaganib, RedHill's second COVID-19 candidate, is expected Q2/2021

RedHill Biopharma Ltd. [https://www.redhillbio.com/RedHill/] (Nasdaq: RDHL)

("RedHill" or the "Company"), a specialty biopharmaceutical company, today

announced that the first patient was dosed in its U.S. Phase 2/3 study of

orally-administered RHB-107 (upamostat)[1], an investigational new drug for

patients with symptomatic COVID-19 who do not require hospital care.

Dror Ben-Asher, RedHill's CEO said: "RedHill is rapidly advancing two Phase

3-stage, orally-administered, novel molecules for the treatment of COVID-19:

RHB-107 for outpatient use and opaganib for hospitalized patients. With these

two promising and complementary shots on goal across the disease severity

spectrum, RedHill is positioned at the very forefront of COVID-19 therapeutic

research, aiming to address both existing and emerging mutations."

The U.S. Phase 2/3 study (NCT04723527

[https://clinicaltrials.gov/ct2/show/NCT04723537?term=RHB-107&draw=2&rank=1])

is aimed at evaluating treatment with RHB-107 in patients with symptomatic

COVID-19 early in the course of the disease, with a simple once-daily oral

treatment in an outpatient setting.

RHB-107 is a novel, potent inhibitor of serine proteases, that targets human

cell factors involved in preparing the spike protein for viral entry into

target cells and is therefore expected to be effective against emerging viral

variants with mutations in the spike protein. RHB-107 demonstrated strong

inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial

epithelial cell model and previous preclinical work demonstrated potential

tissue-protective action. Previous clinical studies of RHB-107 included several

Phase 1 and Phase 2 studies in different indications, demonstrating its

clinical safety profile in approximately 200 patients.

"Dosing of the first patient in the Phase 2/3 study of RHB-107 in patients with

symptoms but not needing hospital care, the largest COVID-19 patient group, is

a key step forward in RedHill's efforts to help combat the widespread effects

of this pandemic. Together with opaganib, we now have two novel,

orally-administered compounds, with unique mechanisms of action, in advanced

development for treating patients at different stages of COVID-19 disease,"

said Terry F. Plasse MD, Medical Director at RedHill. "The ability to treat

patients early in the course of COVID-19 disease, with an oral therapy designed

to be used outside the hospital, and with a compound expected to be effective

against emerging viral variants, has the potential to be a game-changer in

managing this disease. The ground-breaking design of the study allows us to

collect data at a level previously possible only in hospital while enabling

patients to stay in the comfort of their homes and decreasing exposure risk of

this highly contagious disease."

This study is a 2-part, multicenter, randomized, double-blind,

placebo-controlled, parallel-group study to evaluate the safety and efficacy of

RHB-107. The first part of the study is designed for dose selection and is

planned to enroll 60 patients. The second part of the study is planned to

enroll 250 patients and will evaluate time to sustained recovery from illness

as the primary endpoint. Each patient will be tested for specific viral strain.

The study is unique in a COVID-19 trial setting in its extensive use of

telemetry and electronic patient-reported outcome (ePRO) data collection and is

based on the latest FDA guidance for symptom monitoring. Following the

patients' initial visit to a medical facility, a research-trained nurse will

make periodic home visits to study patients to collect samples for safety and

virology monitoring. This innovative use of home-based safety and efficacy

monitoring technologies, together with home nursing support, enables patients

to participate in the study from home with the benefit of hospital-level

monitoring, enhancing patient comfort and markedly decreasing the risk of

SARS-CoV-2 exposure to medical staff and other members of the public.

In parallel, the late-stage development program for RedHill's second COVID-19

drug candidate, opaganib[2] in patients hospitalized with severe COVID-19, is

progressing rapidly. Recently announced top-line results

[https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=1

78&FID=2432&PID=0&IID=19319] from the U.S. Phase 2 study of opaganib

demonstrated safety and positive efficacy data across key primary and secondary

endpoints. The global Phase 2/3 study continues to enroll, having recently

received a positive DSMB futility review

[https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=1

78&FID=4457&PID=0&IID=19326], with top-line data and potential subsequent

global emergency use authorization applications expected in the second quarter

of 2021.

About RHB-107 (upamostat)

RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor

of several serine proteases, with demonstrated antiviral and potential

tissue-protective effects. RHB-107 targets human cell factors involved in

preparing the spike protein for viral entry into target cells and is therefore

expected to be effective against emerging viral variants with mutations in the

spike protein. RHB-107 is being evaluated in a U.S. Phase 2/3 study for

treatment of patients with symptomatic COVID-19 who do not require inpatient

care. In addition, RHB-107 has potential in targeting cancer, inflammatory lung

diseases and gastrointestinal diseases. RHB-107 has undergone several Phase 1

studies and two Phase 2 studies, demonstrating its clinical safety profile in

approximately 200 patients. RedHill acquired the exclusive worldwide rights to

RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's

Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company

primarily focused on gastrointestinal and infectious diseases. RedHill promotes

the gastrointestinal drugs, Movantik® for opioid-induced constipation in

adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori)

infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea

in adults[5]. RedHill's key clinical late-stage development programs include:

(i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous

mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a

first-in-class SK2 selective inhibitor targeting multiple indications with a

Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and

cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease

inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and

targeting multiple other cancer and inflammatory gastrointestinal diseases;

(iv) RHB-104, with positive results from a first Phase 3 study for Crohn's

disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for

acute gastroenteritis and gastritis and positive results from a Phase 2 study

for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More

information about the Company is available at http://www.redhillbio.com,

https://twitter.com/RedHillBio.

This press release contains "forward-looking statements" within the meaning of

the Private Securities Litigation Reform Act of 1995. Such statements may be

preceded by the words "intends," "may," "will," "plans," "expects,"

"anticipates," "projects," "predicts," "estimates," "aims," "believes,"

"hopes," "potential" or similar words. Forward-looking statements are based on

certain assumptions and are subject to various known and unknown risks and

uncertainties, many of which are beyond the Company's control and cannot be

predicted or quantified, and consequently, actual results may differ materially

from those expressed or implied by such forward-looking statements. Such risks

and uncertainties include, without limitation, the risk that enrollment in the

Company's Phase 2/3 study evaluating RHB-107 in patients with symptomatic

COVID-19 will be delayed, not completed or not successful; the risk that

RHB-107 will not be effective against emerging viral variants with mutations in

the spike protein; the risk that the Company's Phase 2/3 development program

evaluating opaganib will not be successful and that the data from this clinical

study will be delayed, if at all; the risk of a delay in receiving data to

support emergency use applications or in making such emergency use

applications, if at all;; the risk that the Company will not initiate the Phase

2/3 study for opaganib in certain geographies, will not expand this study to

additional countries and that it will not be successful and that enrollment

will be delayed; the risk that other COVID-19 patients treated with RHB-107 or

opaganib will not show any clinical improvement; the development risks of

early-stage discovery efforts for a disease that is still little understood,

including difficulty in assessing the efficacy of RHB-107 and opaganib for the

treatment of COVID-19, if at all; intense competition from other companies

developing potential treatments and vaccines for COVID-19; the effect of a

potential occurrence of patients suffering serious adverse events using

opaganib under compassionate use programs, as well as risks and uncertainties

associated with (i) the initiation, timing, progress and results of the

Company's research, manufacturing, preclinical studies, clinical trials, and

other therapeutic candidate development efforts, and the timing of the

commercial launch of its commercial products and ones it may acquire or develop

in the future; (ii) the Company's ability to advance its therapeutic candidates

into clinical trials or to successfully complete its preclinical studies or

clinical trials (iii) the extent and number and type of additional studies that

the Company may be required to conduct and the Company's receipt of regulatory

approvals for its therapeutic candidates, and the timing of other regulatory

filings, approvals and feedback; (iv) the manufacturing, clinical development,

commercialization, and market acceptance of the Company's therapeutic

candidates and Talicia®; (v) the Company's ability to successfully

commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's

ability to establish and maintain corporate collaborations; (vii) the Company's

ability to acquire products approved for marketing in the U.S. that achieve

commercial success and build and sustain its own marketing and

commercialization capabilities; (viii) the interpretation of the properties and

characteristics of the Company's therapeutic candidates and the results

obtained with its therapeutic candidates in research, preclinical studies or

clinical trials; (ix) the implementation of the Company's business model,

strategic plans for its business and therapeutic candidates; (x) the scope of

protection the Company is able to establish and maintain for intellectual

property rights covering its therapeutic candidates and commercial products and

its ability to operate its business without infringing the intellectual

property rights of others; (xi) parties from whom the Company licenses its

intellectual property defaulting in their obligations to the Company; (xii)

estimates of the Company's expenses, future revenues, capital requirements and

needs for additional financing; (xiii) the effect of patients suffering adverse

events using investigative drugs under the Company's Expanded Access Program;

and (xiv) competition from other companies and technologies within the

Company's industry. More detailed information about the Company and the risk

factors that may affect the realization of forward-looking statements is set

forth in the Company's filings with the Securities and Exchange Commission

(SEC), including the Company's Annual Report on Form 20-F filed with the SEC on

March 4, 2020. All forward-looking statements included in this press release

are made only as of the date of this press release. The Company assumes no

obligation to update any written or oral forward-looking statement, whether as

a result of new information, future events or otherwise unless required by law.

1. RHB-107 (upamostat) is an investigational new drug, not available for

commercial distribution in the United States.

2. Opaganib (Yeliva®, ABC294640) is an investigational new drug, not available

for commercial distribution in the United States.

3. Full prescribing information for Movantik® (naloxegol) is available at:

http://www.movantik.com.

4. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin

and rifabutin) is available at: http://www.talicia.com.

5. Full prescribing information for Aemcolo® (rifamycin) is available at:

http://www.aemcolo.com.

Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contacts:

U.S.: Bryan Gibbs, Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

UK: Amber Fennell, Consilium

+44 (0) 7739 658 783  

fennell@consilium-comms.com

Source: RedHill Biopharma Ltd.