Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill - LARVOL DELTA

Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. (PubMed, Antibiotics (Basel)) - P3 | "A double-blind multicenter study of adults with active Crohn's disease, (i.e., Crohn's Disease Activity Index [CDAI] 220-450 plus C-reactive protein ≥ 1.0 mg/dL, fecal calprotectin (FCP) >162.9 µg/g stool, or recent endoscopic or radiographic confirmation of active disease) receiving concomitant standard-of-care Crohn's disease treatment (Clinicaltrials.gov: NCT01951326) were stratified by anti-tumor necrosis factor use and randomized (1:1) to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166), resulting in clarithromycin 950 mg/day, rifabutin 450 mg/day, and clofazimine 100 mg/day, or placebo (n = 165) for up to 52 weeks. No patient died during the study. Antimicrobial therapy directed against MAP resulted in significantly greater improvement in clinical and laboratory (FCP) measures of active Crohn's disease."

Clinical • Journal • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Respiratory Diseases • Tuberculosis • CRP • TNFA

Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease (PRNewswire) - P3 | N=331 | MAPUS (NCT01951326) | Sponsor: RedHill Biopharma Limited | "RedHill Biopharma...announced the new publication of ground-breaking positive data showing that triple antimicrobial therapy with RHB-104 plus standard of care (SoC)...is 64% more effective than SoC alone in Crohn's disease....The data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of anti-mycobacterial therapy (RHB-104) in active Crohn's disease, was published in the peer-reviewed journal, Antibiotics. In the global study...a total of 166 patients were randomized to receive RHB-104 plus SoC and 165 to placebo plus SoC. Data for the primary endpoint, clinical remission at week 26, shows, with high statistical significance, that 36.7% (61/166) of RHB-104 patients achieved clinical remission at week 26 vs. 22.4% (37/165) of placebo patients (p = 0.0048). RHB-104 was found to be generally safe and well tolerated, with adverse event reporting similar to placebo."

P3 data • Crohn's disease

"Why not abx ? Anti-map ? RHB-104 ?" (@AndyAdd0222)

"Is it valuable to relook ? https://t.co/9cxqTbaMTr ? Or RHB-104 (Redhill) ? Need your advice" (@AndyAdd0222)

"$RDHL RedHill Biopharma Announces Two New U.S. Patents Covering Opaganib for Ebola Virus and RHB-104 for Crohn's https://t.co/EajCKzimCW #patent" (@stock_titan)

Crohn's disease • Gastroenterology • Immunology • Infectious Disease

Myoconda: Expiry of patents in US and ex-US related to use in treating inflammatory bowel disease in 2029 (RedHill) - Annual Report 2020: Expiry of patents for the detection of mycobacterium avium subspecies paratuberculosis (MAP) bacterium in US in 2022 and 2026

Patent • Inflammatory Bowel Disease

Royalty Pharma announces proposal to acquire Elan (PRNewswire) - "Royalty Pharma is proposing, on an indicative basis, to make an offer for Elan...of US$11[1] for every Elan Share and every Elan ADS...Royalty Pharma believes that the Proposal offers Elan Shareholders an attractive financial alternative that will allow them to realize value for their Elan Stock in cash immediately. Royalty Pharma notes that while Elan's management has demonstrated its ability to execute several significant disposals, including the sale of some or all of bapineuzumab."

Anticipated licensing / partnership • Sales • Alzheimer's Disease

RedHill Biopharma reports 2013 fourth quarter and year-end financial results (RedHill Press Release) - "Research and Development Expenses, net for the quarter ended December 31, 2013 were approximately $2.6 million...The increase was mainly due to the commencement of the Phase III clinical studies with RHB-104 (Crohn's disease)...The Phase III MAP Europe study is planned to commence during the first half of 2014, subject to regulatory approvals."

Anticipated EU regulatory • Anticipated new P3 trial • Commercial • Inflammatory Bowel Disease

RedHill Biopharma reports 2016 fourth quarter and full-year financial results (RedHill Press Release) - "Second independent DSMB meeting for the MAP US Phase III study with RHB-104 for Crohn's disease, including an interim efficacy analysis and an evaluation of an option for early stop for success for overwhelming efficacy, expected in Q2/2017...completion of recruitment is expected by the end of 2017...A Phase II study to evaluate the efficacy of YELIVA® in patients with moderate to severe ulcerative colitis is planned to be initiated in the second half of 2017."

Anticipated DSMB • Anticipated enrollment status • Inflammation • Inflammatory Bowel Disease

RedHill Biopharma announces first patient dosed in the open-label extension study to the phase III study with RHB-104 for Crohn's disease (RedHill Press Release) - P3, N=266; NCT01951326; Sponsor: RedHill Biopharma Limited; To date, 266 patients out of a planned total of 410 patients have been enrolled in the study...second independent Data and Safety Monitoring Board (DSMB) meeting of the MAP US Phase III study, expected in mid-2017, will include an interim efficacy analysis and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold...completion of recruitment for the MAP US study is expected by the end of 2017."

DSMB • Enrollment status • Inflammation • Inflammatory Bowel Disease

RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn's disease associated with Mycobacterium paratuberculosis. (PubMed) - Gut Pathog - "The data clearly demonstrated that lower concentrations of the triple combination of RHB-104 active ingredients provided synergistic anti-MAP growth activity compared to individual or dual combinations of the drugs. Consequently, this is favorable and should lead to tolerable dosage that is desirable for long-term treatment of CD and Mycobacterium avium complex disease."

Journal • Biosimilar • Crohn's Disease • Immunology • Inflammatory Bowel Disease

RedHill Biopharma's RHB-104 combination achieves 80% remission in independent pediatric Crohn's study (Globenewswire) - P=NA, N=10; "The retrospective study, presented at the 2013 American College of Gastroenterology (ACG) Annual Scientific Meeting, demonstrated strong results with a high remission rate of 80%." Phase III RHB-104 study is planned in Europe by mid-2014.

Anticipated new P3 trial • Retrospective data • Inflammatory Bowel Disease

RedHill Biopharma closes previously announced $11.7 million private placement (RedHill Press Release) - "RedHill Biopharma...announced that it has closed, on January 21, 2014, its previously announced private placement (the 'Private Placement') of ordinary shares and warrants for approximately $11.7 million....With over $30 million in cash, we continue to aggressively pursue our strategic plans and advance our lead programs, RHB-104 for Crohn's disease..."

Commercial • Inflammatory Bowel Disease

RedHill announces interim results from phase IIa PoC study supporting therapeutic potential of RHB-104 in multiple sclerosis (RedHill Press Release) - P2a, N=18; CEASE-MS (NCT01717664); Sponsor: RedHill Biopharma; "The EDSS scale is a standard for monitoring MS patients. EDSS scores in the study were stable at 24 weeks and were suggestive of improvement. Importantly, no increase in total EDSS was observed in any of the patients in the study...There were no clinically relevant or unexpected adverse events reported in the study..."

P2 data • Multiple Sclerosis

RedHill Biopharma provides update on development pipeline and expected timing for RHB-105 Phase III top-line results (GlobeNewswire) - "Last patient screened in the Phase IIa Proof of Concept study with RHB-104 for multiple sclerosis, with interim results expected in Q4/15 - Q1/16”

Anticipated P2 data • Trial status • Multiple Sclerosis

RedHill Biopharma to host 2015 fourth quarter and year-end financial results conference call on February 25, 2016 (GlobeNewswire) - "RedHill Biopharma...today announced that it will report its 2015 fourth quarter and year-end financial results on Thursday, February 25, 2016."

Anticipated commercial • Multiple Sclerosis • Rheumatoid Arthritis

RedHill Biopharma reports third quarter 2018 financial results and business highlights (GlobeNewswire) - "Research and Development Expenses for the third quarter of 2018 were $6.6 million, a decrease of 18% from the third quarter of 2017. The decrease was mainly due to the finalization of the Phase III study with RHB-104 and completion of the clinical studies with BEKINDA® (RHB-102)."

Commercial • Immunology • Inflammation • Inflammatory Bowel Disease

RHB-104: “Demonstrated consistent treatment effect favoring RHB-104 in both the protocol defined primary endpoint of 26 weeks (∆14% with p-value = 0.013) and secondary endpoint of early remission at 16 weeks (∆13% with p-value = 0.019)” (RedHill) - Clinical Trial Data

P3 data: top line • Immunology • Inflammation • Inflammatory Bowel Disease

RedHill: Jefferies London Healthcare Conference 2016 (RedHill, Jefferies 2016 London Healthcare Conference) - Anticipated second DSMB safety and interim efficacy analysis of P3 MAP US trial (NCT01951326) for Crohn’s disease in Q2 2017

Anticipated DSMB • Inflammatory Bowel Disease

RedHill: Corporate Presentation (RedHill) - Anticipated DSMB safety and futility analysis of P3 MAP US trial (NCT01951326) for Crohn’s disease in Q4 2016

Anticipated DSMB • Inflammatory Bowel Disease

RedHill Biopharma: Clinical Update (RedHill) - Anticipated patent protection in EU until 2032  

Anticipated patent expiry • Inflammatory Bowel Disease

RHB-104: Completion of enrollment in P3 MAP US trial (NCT01951326) for Crohn’s disease by November 2017 (RedHill) - RHB-104 Update Conference Call: Top-line data from P3 MAP US trial in Crohn's disease in mid-2018

Enrollment status • P3 data: top line • Immunology • Inflammation • Inflammatory Bowel Disease

RedHill Biopharma announces last patient enrolled in the phase III study with RHB-104 for Crohn's disease (RedHill Press Release) - P3, N=331; NCT01951326; Sponsor: RedHill; "RedHill Biopharma...today announced that the last patient has been enrolled in the Phase III study with RHB-104 for Crohn's disease (MAP US study). Top-line results are expected to be announced in mid-2018."

Enrollment closed • P3 data: top line • Immunology • Inflammation • Inflammatory Bowel Disease

RedHill Biopharma announces first patient dosed in the open-label extension study to the phase III study with RHB-104 for Crohn's disease (RedHill Press Release) - P3, N=100; NCT03009396; Sponsor: RedHill Biopharma Limited; "RedHill...today announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn's Disease (the MAP US study)...Additional open-label studies with RHB-104 for Crohn's disease are being planned by RedHill, to provide further supportive clinical data for potential future marketing applications...This study is considered separate from the ongoing MAP US Phase III study, and data collected will be supplemental to the MAP US study data."

Enrollment open • New trial • P3 data • Inflammation • Inflammatory Bowel Disease

RedHill Biopharma announces positive top-line results from phase III study of RHB-104 in Crohn’s disease (GlobeNewswire) - P3, N=330; MAP US (NCT01951326); Sponsor: RedHill Biopharma; "RedHill Biopharma Ltd...announced positive top-line safety and efficacy results from the first Phase III study with RHB-104 for Crohn’s disease (the MAP US study). The study successfully met its primary endpoint and key secondary endpoints....Top-line results demonstrated...positive safety profile for RHB-104...Continue to analyze the study data and plan to meet with key opinion leaders and the FDA to present the data package and discuss the development path to potential approval of RHB-104."

P3 data: top line • Immunology • Inflammation • Inflammatory Bowel Disease