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

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