PR86751

TEL AVIV, Israel and RALEIGH, N.C., Nov. 17, 2020 /PRNewswire=KYODO JBN/ --

FDA clears IND application for Phase 2/3 study with RedHill's second novel

COVID-19 candidate, RHB-107 (upamostat), an orally administered novel serine

protease inhibitor, with demonstrated antiviral and potential tissue-protective effects

The Phase 2/3 study is designed to evaluate outpatient-based treatment of

patients with symptomatic COVID-19 disease – the vast majority of treated patients

RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in a

human bronchial cell model and targets a host cell component involved in viral

replication, minimizing potential for resistance due to viral mutations

In parallel, RedHill is rapidly advancing its development program with opaganib

in severe COVID-19 pneumonia; The U.S. Phase 2 study is fully enrolled with

topline data expected within weeks, and a global Phase 2/3 study which is more

than 50% enrolled, with topline data expected in Q1/2021 in support of

potential emergency use applications

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

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

announced that the U.S. Food and Drug Administration (FDA) has cleared the

Company's Investigational New Drug (IND) application for a Phase 2/3 study

evaluating orally administered RHB-107 (upamostat)[1] in patients with

symptomatic COVID-19 who do not require hospitalization.

"This is a significant milestone in our efforts to combat the effects of the

COVID-19 pandemic. The ability to treat patients earlier in the course of

COVID-19 disease, using an oral therapy that enables treatment outside of a

hospital setting, is of critical importance given the large proportion of

patients that are not hospitalized but are still very much at risk of disease

progression," said Terry F. Plasse MD, Medical Director at RedHill. "With

RHB-107 and opaganib[2], RedHill has two novel, late-stage, oral therapeutic

candidates with potential to reduce the impact of COVID-19 disease, both of

which target host cell components, potentially minimizing the likelihood of

resistance due to emergence of viral mutations."

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

of several serine proteases, with demonstrated antiviral and potential

tissue-protective effects. This combined antiviral and potential

tissue-protective action make it a promising candidate for evaluation as a

treatment for COVID-19 disease. RHB-107 has demonstrated strong inhibition of

SARS-CoV-2 viral replication in an in vitro human bronchial cell model and its

safety profile has been demonstrated in approximately 200 people, including in

Phase 2 studies in oncology indications. RedHill licensed RHB-107 (formerly

Mesupron) from Heidelberg Pharma AG (FWB: HPHA, formerly Wilex AG).

The randomized, parallel-group double-blind Phase 2/3 study is expected to

start enrolling patients early next year. The study will enroll patients with

symptomatic diagnostically confirmed COVID-19 who do not require inpatient

care. RHB-107 will be administered once daily for 14 days, with patients

receiving follow-up for eight weeks from first dosing. The primary endpoints

will be time to recovery from symptomatic illness compared to placebo, as well

as safety and tolerability of RHB-107. Several secondary and exploratory

endpoints will also be assessed.

The late-stage development program for RedHill's other COVID-19 candidate,

opaganib, in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2

study (NCT04414618) is now fully enrolled and expected to report topline data

in the coming weeks; and the global Phase 2/3 study (NCT04467840) which is more

than 50% enrolled and is on track to enroll up to 270 patients and report

topline data in support of potential emergency use applications in the first

quarter of 2021. Both studies are randomized, double-blind, parallel-arm,

placebo-controlled trials with opaganib in patients with severe COVID-19

pneumonia requiring hospitalization and treatment with supplemental oxygen.

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. This combined antiviral and potential

tissue-protective action make it a strong candidate for evaluation as a

treatment for COVID-19 disease. In addition, RHB-107 has potential in targeting

cancer, inflammatory lung diseases and gastrointestinal diseases, and 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 (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(R) for opioid-induced constipation in

adults with non-cancer pain[3], Talicia(R) for the treatment of Helicobacter

pylori (H. pylori) infection in adults[4], and Aemcolo(R) for the treatment of

travelers' diarrhea in adults[5]. RedHill's key clinical late-stage

investigational development programs include: (i) RHB-204, with a planned Phase

3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib

(Yeliva(R)), 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-104, with positive

results from a first Phase 3 study for Crohn's disease; (iv) RHB-102

(Bekinda(R)), with positive results from a Phase 3 study for acute

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

IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease

inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is

also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel

preparation. More information about the Company is available at

www.redhillbio.com.

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, 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 U.S. Phase 2 clinical study

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

clinical study will be delayed 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 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 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(R); (v) the Company's ability to successfully

commercialize and promote Movantik(R), Talicia(R) and Aemcolo(R); (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.

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contact (U.S.):

Bryan Gibbs

Vice President

Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

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

commercial distribution.

[2] Opaganib is an investigational new drug, not available for commercial

distribution

[3] Full prescribing information for Movantik(R) (naloxegol) is available at:

www.Movantik.com.  

[4] Full prescribing information for Talicia(R) (omeprazole magnesium,

amoxicillin and rifabutin) is available at: www.Talicia.com.      

[5] Full prescribing information for Aemcolo(R) (rifamycin) is available at:

www.Aemcolo.com.

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Source - RedHill Biopharma Ltd.