Form 6-K RedHill Biopharma Ltd. For: May 25

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

  

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

 

For the month of May 2022
Commission File No.:001-35773

 

REDHILL BIOPHARMA LTD.

(Translation of registrant’s name into English)

 

21 Ha'arba'a Street, Tel Aviv, 6473921, Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.  

Form 20-F ☒ Form 40-F ☐

 

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____ 

 

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled:  "RedHill Presents New Talicia® Data Analyses at DDW 2022".

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. 

 

 

 

Press Release

 

Talicia’s efficacy and safety profile evaluated in patients with H. pylori infection and diabetes

mellitus, a large and challenging patient population associated with sub-optimal outcomes with

clarithromycin-based H. pylori eradication therapy

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Physiologically based pharmacokinetic modeling study of Talicia evaluated intragastric

antibiotic exposure, which is critical for successful H. pylori eradication, by comparing low-dose

rifabutin 50 mg every 8 hours to the generic formulation of rifabutin 150 mg once a day

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Talicia, the leading FDA-approved brand for H. pylori treatment, is intended for empiric first-line

eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S.

adult population, representing significant unmet need

 

RALEIGH, N.C. and TEL AVIV, Israel, May 25, 2022, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, announced the presentation of two new data analyses from the Talicia^® H. pylori eradication clinical trials program at Digestive Diseases Week (DDW) 2022.

The first analysis evaluated the maintenance of Talicia’s efficacy and safety in the treatment of patients with H. pylori infection and diabetes mellitus (DM). DM is associated with higher rates of H. pylori infection and higher rates of treatment failure with clarithromycin-based therapies. Furthermore, clarithromycin interacts with some common diabetes medications potentially leading to hypoglycemia¹.

The second analysis, a physiologically based pharmacokinetic (PBPK) study, used modeling to compare Talicia’s low-dose rifabutin formulation’s (rifabutin 50 mg every 8 hours) sustained intragastric antibiotic exposure, a critical component of successful H. pylori eradication, to exposure rates seen with the generic formulation of rifabutin (150 mg taken once daily (QD)).

This supplemental analysis of the pooled modified intent-to-treat (mITT) population (n=293) from two Phase 3 clinical trials (ERADICATE Hp, ERADICATE Hp2) assessed the safety and efficacy of Talicia in patients with DM. H. pylori isolates from treatment-naïve patients from study 2 were also tested for antibiotic resistance according to the presence of DM. The 293 patient-analyzable mITT population who received Talicia had pooled eradication rates of 91.7% (n=44) and 84.1% (n=206) in patients with and without DM, respectively (p=0.17). Moreover, no resistance was seen to rifabutin in patients with or without DM. Resistance rates were 4% v 7% for amoxicillin, 45% v 43% for metronidazole, and 21% v 17% resistance to clarithromycin in patients with and without DM, respectively. With the exception of an observed higher rate of diarrhea in patients without diabetes versus those with (13.8% vs 6%), the presence of diabetes did not alter the safety or tolerability of Talicia, and generally matched the safety profile of the total patient population.  

Sufficient intragastric antibiotic exposure is critical for eradication of H. pylori. Consequently, understanding the influence of antibiotic dosing on intragastric exposure is imperative. This study used PBPK modeling to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) administered every 8 hours (Q8H) vs. rifabutin 150 mg (the generically available dose) administered once daily (QD). Intragastric rifabutin concentration time above the mean inhibitory concentration (MIC₉₀ = 0.008 mcg/mL) was calculated over a 24-hour period for each regimen. Low-dose rifabutin 50 mg Q8H, as in Talicia, maintained intragastric rifabutin concentrations at or above the MIC₉₀ for approximately three times longer than rifabutin 150 mg QD. When taken with food (as indicated in the prescribing information), low-dose rifabutin 50 mg Q8H, as in Talicia, provided intragastric concentrations at or above the MIC₉₀ for about 93% of the day, compared to 35% of the day when dosed as 150 mg QD.  

“These important new data enhance the body of evidence supporting the use of Talicia as a first line therapy for H. pylori,” said Dr. June Almenoff, MD, Ph.D., RedHill’s Chief Medical Officer. “Talicia consistently shows its ability to maintain high H. pylori eradication rates, even in challenging patient populations, with zero to minimal resistance. This work also demonstrates Talicia’s sustained intragastric exposure, providing optimized conditions for eradication of H. pylori at the first treatment attempt.”

About Talicia^®
Talicia^® is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

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 adults¹², Talicia^® for the treatment of Helicobacter pylori (H. pylori) infection in adults¹³, and Aemcolo^® for the treatment of travelers’ diarrhea in adults¹⁴. 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 hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a Phase 2/3 study as treatment for non-hospitalized 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/ twitter.com/RedHillBio.

Full prescribing information for Talicia is available at www.Talicia.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, including without limitation risks regarding the treatment effectiveness of Talicia and the risk that the Company will not succeed to expand Talicia’s reach to additional ex-U.S. territories; as well as other risk and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical 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 pre-clinical 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 Talicia^®, Aemcolo^® and Movantik^®; (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 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, pre-clinical 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 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 experiences 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 17, 2022. 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 [email protected]

Media contacts: U.S.  / UK: Amber Fennell, Consilium +44 (0) 7739 658 783   [email protected]

¹ Kennedy KE, Teng C, Patek TM, Frei CR. Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS). Drug Saf. 2020 Apr;43(4):363-369. doi: 10.1007/s40264-019-00901-7. PMID: 31863282; PMCID: PMC7117991.

² Chey WD, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection [published correction appears in Am J Gastroenterol. 2018 Jul;113(7):1102]. Am J Gastroenterol. 2017;112(2):212-239.

Horikawa C, et al. High risk of failing eradication of Helicobacter pylori in patients with diabetes: a meta-analysis. Diabetes Res Clin Pract. 2014;106(1):81-87.

³ Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.

⁴ IQVIA Custom Study for RedHill Biopharma, 2019

⁵ Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.

⁶ NIH – Helicobacter pylori and Cancer, September 2013.

⁷ Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.

⁸ National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).

⁹ Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.

¹⁰ Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.

¹¹ The pivotal Phase 3 study with Talicia^® demonstrated 84% eradication of H. pylori infection with Talicia^® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).

¹² Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.

¹³ Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

¹⁴ Aemcolo^® (rifamycin) is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.