RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval

PR91627

TEL AVIV, Israel and RALEIGH, N.C., Sept. 13, 2021 /PRNewswire=KYODO JBN/ --

- The South African Health Products Regulatory Authority (SAHPRA) has approved

the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for

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

- Number of U.S. sites for the study has also been expanded

- RHB-107, a novel antiviral serine protease inhibitor targeting human cell

factors, is expected to be effective against emerging viral variants

- RHB-107 is being developed as a potential treatment with a simple once-daily

oral pill in the early course of COVID-19

- In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being

evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe

COVID-19, with top-line results upcoming

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

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

announced that South Africa has joined the U.S. in approving the Phase 2/3

study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1]

for non-hospitalized patients with symptomatic COVID-19. The study is already

ongoing in the U.S., with expansion of study sites underway to further

accelerate recruitment.

RHB-107 is a novel antiviral drug candidate that targets human serine proteases

involved in preparing the spike protein for viral entry into target cells.

Because it is host-cell targeted, RHB-107 is expected to also be effective

against emerging viral variants with mutations in the spike protein. RHB-107

has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in

vitro human bronchial epithelial cell model. RHB-107 has a strong clinical

safety and biodistribution profile, demonstrated in previous clinical studies,

including several Phase 1 and Phase 2 studies in different indications, in

approximately 200 patients.

"South Africa continues to face an onslaught of COVID-19 that is claiming many

lives and causing significant distress to the healthcare system. South Africa,

along with the U.S. and rest of the world, urgently need the ability to easily

and effectively treat COVID-19 and its variants, both inside and outside the

hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As

clearly highlighted recently by the Director of NIAID, it is important to be

able to treat patients early in the course of the disease to prevent

progression to more severe symptoms. The approval of this study in South

Africa, along with the expansion of study sites in the U.S., are aimed at

accelerating our efforts to bring RedHill's two novel, oral compounds that

cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to

patients across the world."

The Phase 2/3 study (NCT04723527

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

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

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

treatment that can be prescribed and used in the largest, non-hospitalized,

patient population. The study is a 2-part, multicenter, randomized,

double-blind, placebo-controlled, parallel-group study to evaluate the safety

and efficacy of RHB-107. The study is designed for dose selection and to

evaluate time to sustained recovery from illness as the primary endpoint.

Patients are also tested for specific viral strain.

In parallel, top-line results are upcoming from the opaganib[2] global

475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 -

RedHill's other advanced COVID-19 oral drug candidate.

About RHB-107 (upamostat)

RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that

targets human serine proteases involved in preparing the spike protein for

viral entry into target cells. 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 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 several indications in oncology,

inflammatory and gastrointestinal disease. 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(R) for opioid-induced constipation in

adults, Talicia(R) for the treatment of Helicobacter pylori (H. pylori)

infection in adults, and Aemcolo(R) for the treatment of travelers' diarrhea in

adults. 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 ( ABC294640), a first-in-class, oral

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), an oral 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,

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 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 and/or opaganib 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 RHB-107 and/or 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 RHB-107 in certain geographies, including

South Africa, will not expand this study to additional sites in the U.S. and

that it will not be successful and that enrollment will be delayed; the risk

that 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 relatively new disease, 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 RHB-107, 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(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 18, 2021. 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 (ABC294640) is an investigational new drug, not available for

commercial distribution in the United States.

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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 658783  

fennell@consilium-comms.com

Source: RedHill BioPharma Ltd.