clarithromycin/clofazimine/rifabutin (RHB-204) / RedHill - LARVOL DELTA

RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease (PRNewswire) - "RHB-204 is patent protected through 2041...The comparability results were achieved in both spot and phage assays of several different MAP strains. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects...A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population."

New P2 trial • Patent • Preclinical • Crohn's disease

RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease (PRNewswire) - "RedHill Biopharma...announced that it received positive feedback from the U.S. Food and Drug Administration (FDA), following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company's potentially groundbreaking RHB-204 Crohn's disease (CD) development program. The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in Crohn's disease to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) CD patients....The Phase 2 study is expected to have primary endpoints of mucosal remission (considered by FDA as a new gold standard in efficacy evaluation in Crohn's disease), correlated with MAP status and clinical remission, per FDA guidance....Funding for this ground-breaking program is expected to be non-dilutive. RedHill is actively pursuing partnering and collaborations for this program..."

Commercial • FDA event • New P2 trial • Crohn's disease

CleaR-MAC: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (clinicaltrials.gov) - P3 | N=12 | Terminated | Sponsor: RedHill Biopharma Limited | N=125 ➔ 12 | Active, not recruiting ➔ Terminated; extremely slow enrollment into study

Enrollment change • Trial termination • Bronchiectasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn’s Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results (PRNewswire) - "Patent protected until 2041...RedHill Biopharma Ltd...today announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter."

FDA event • New P2 trial • Patent • Crohn's disease

CleaR-MAC: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (clinicaltrials.gov) - P3 | N=125 | Active, not recruiting | Sponsor: RedHill Biopharma Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Bronchiectasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

RedHill Receives USPTO Notice of Allowance for a Patent Covering Phase 3-stage RHB-204 for the Treatment of NTM Disease (PRNewswire) - "RedHill Biopharma Ltd...today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the granting of a patent covering RHB-204's1 oral fixed-dose combination, methods for treating pulmonary Mycobacterium avium Complex (MAC) disease, and kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease. Once issued, the patent is expected to protect RHB-204 through 2041."

Patent • Bronchiectasis • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

CleaR-MAC: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (clinicaltrials.gov) - P3 | N=125 | Recruiting | Sponsor: RedHill Biopharma Limited | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Aug 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Bronchiectasis • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] RedHill Biopharma (BIO 2021) - "RedHill promotes the gastrointestinal drugs Movantik® (OIC), Talicia® (H. pylori) and Aemcolo® (travelers' diarrhea). RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for NTM disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing 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, as well as additional late-stage asset assets. More information about the Company is available at www.redhillbio.com."

Biliary Cancer • Cholangiocarcinoma • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Prostate Cancer • Solid Tumor

CleaR-MAC: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (clinicaltrials.gov) - P3; N=125; Recruiting; Sponsor: RedHill Biopharma Limited; Not yet recruiting ➔ Recruiting

Enrollment open • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

CleaR-MAC: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (clinicaltrials.gov) - P3; N=125; Not yet recruiting; Sponsor: RedHill Biopharma Limited

New P3 trial • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

RedHill Biopharma to provide update on its Covid-19 and other development programs at MedInvest Virtual Infectious Diseases and Immunology Conference (RedHill Press Release) - "RedHill Biopharma Ltd....today announced that Mr. Gilead Raday, RedHill’s Chief Operating Officer, will present the Company’s development program with opaganib (Yeliva®, ABC294640)1 for COVID-19, as well as the Phase 3 development program with RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections, at the MedInvest Virtual Infectious Diseases and Immunology Conference on Monday, June 15, 2020, at 12:40 p.m. EDT."

Live event • Infectious Disease • Novel Coronavirus Disease