RedHill Biopharma (RDHL) Further Analysis of Phase 2/3 Data Shows 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients

October 4, 2021 8:17 AM EDT

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RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.

These important new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 ≤ 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.

"These new findings support the potential for opaganib's use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib's combined antiviral and anti-inflammatory activities," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher."

"We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib's potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality," said Dror Ben-Asher, RedHill's CEO. "Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib."

Analyses of the FiO2 up to 60% patient subset from the opaganib Phase 2/3 study (n=251), the approximate median for FiO2 levels in the study, who were treated with either opaganib or placebo in addition to standard-of-care (including dexamethasone and/or remdesivir) demonstrate consistent benefit across endpoints, in this subset of hospitalized moderately severe patients. Given the post-hoc characteristics of this subset, statistical inferences of significance cannot be formally attributed (nominal values presented). The Company also conducted a Sensitivity Analysis to account for missing data interpretability[2]:

Mortality: Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8).

A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib.

Reaching Room Air by Day 14 (primary endpoint of the study): 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo - an efficacy benefit of 21% with opaganib (nominal p-value= 0.033).

Median time to discharge: Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195

Safety: Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations. [3]

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy.

The new data of the sub-group analysis follows the Company's previously announced top-line results of the Phase 2/3 study. Analysis of the top-line data is still ongoing, including further analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the study outcomes with regulators, including U.S. FDA and U.S. government agencies, as well as other regulators and governments and international agencies, to help determine next steps.

Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication and is expected to be effective against emerging viral variants, having already preclinically demonstrated strong inhibition against variants of concern, including Delta.

Webcast and Conference Call Information:

The Company will host a webcast on Thursday, October 7, 2021, at 8:30 a.m. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions.

The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167

and Israel: +972-3-530-8845; the access code for the call is: 4785122.



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