Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
– Potential for two-pronged action against COVID-19 as an antiviral and anti-inflammatory agent supported by Phase 2 clinical study results –
– Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29 –
– Statistically significant 82% relative reduction in patient mortality versus placebo–
– Statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation–
– Oral daily dosing well tolerated with no treatment-related adverse events –
– Granted expedited meeting with FDA to discuss Phase 3 trial design and meeting with BARDA to discuss potential funding; Phase 3 clinical study expected to begin in
– Company to host an investor conference call at
“We are very pleased with the results of our Phase 2 trial, which demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, days in the ICU and on mechanical ventilation and patient mortality. We believe VERU-111 has significant potential in treating COVID-19, both as a broad-spectrum antiviral and an anti-inflammatory agent, helping to prevent the effects that lead to ARDS and death,” said
“We are in critical need of effective drugs in high-risk COVID-19 patients. The slow rollout of COVID-19 vaccines, the emergence of new mutant COVID-19 strains and the lack of truly effective drugs in hospitalized, high-risk patients make it critical that we advance VERU-111 and confirm these impressive results in a Phase 3 clinical study as quickly as possible,” said
Veru conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for Acute Respiratory Distress Syndrome (ARDS). The trial was conducted in five sites across
Clinical Efficacy and Safety Results:
For the primary endpoint in hospitalized patients that had >1 dose of study drug, VERU-111 treatment compared to placebo had a statistically significant and clinically meaningful reduction in the proportion of patients who are treatment failures (dead or alive with respiratory failure) with a 30% treatment failure rate in the placebo group (n=20) compared to a 5.6% in the VERU-111 treated group (n=18) at Day 29. This represents an 81% relative reduction in treatment failures and showed statistical significance with p=0.05.
Subgroup analyses of treatment failures (dead or alive with respiratory failure) in patients at high risk for ARDS:
Age: older patients, an analysis of >60 years of age diagnosed with COVID-19 who are at higher risk for death and respiratory failure: Treatment failures were 9% for VERU-111 versus 50% for placebo; p=0.046.
Severity of COVID-19, an analysis of patients with a WHO Score of Disease Severity ≥5 (hospitalized; on oxygen) at baseline: Treatment failures were 11% for VERU-111 versus 54% for placebo; p=0.04.
In the Intent to Treat (ITT) population, VERU-111 reduced the proportion of patients who died on study from 30% (6/20) in the placebo group to 5.3% (1/19) in the VERU-111 treated group (p=0.044). This is a 82% relative reduction in mortality in the VERU-111 treated group.
In patients that received >1 dose of VERU-111 or placebo, VERU-111 showed a statistically significant and clinically meaningful reduction in days in ICU (VERU-111 patients at 3.00 ± 7.16 days versus placebo 9.55 ± 11.54; p=0.04). Additionally, the proportion of patients in the ICU for ≥3 days on study was significantly lower (VERU-111 at 28%, versus placebo, 60%; p=0.046).
VERU-111 reduced the days on mechanical ventilation from an average of 5.4 days in the placebo group to 1.6 days in the VERU-111 treated group.
VERU-111 was tolerated with a good safety profile.
VERU-111 and Standard of Care
During the study, the standard of care included treatment with remdesivir and/or dexamethasone under an Emergency Use Authorization. The use of remdesivir and dexamethasone did not have a significant effect on patient outcomes in the study. A subgroup analysis of patients that received standard of care was conducted. There were six patients in the entire study that did not receive standard of care of either remdesivir or dexamethasone (four in the VERU-111 treated group and two in the placebo group). In patients that received standard of care, VERU-111 treatment resulted in a statistically significant reduction in days in ICU (VERU-111 1.43 ± 3.96 days versus placebo 8.83 ± 13.07 days; p=0.024) and days on mechanical ventilation (VERU-111 zero days versus placebo 6.00 ± 10.57 days; p=0.0427). In the VERU-111 group on standard of care, no patient required mechanical ventilation on study.
As expected, the severity of the COVID-19 infection at baseline, as measured by the WHO scale, was a significant predictor of patient outcomes. The disease severity at baseline was not different between the treatment groups.
Regulatory Discussions and Further Study
The Company has been granted an expedited end-of-Phase 2 meeting with the FDA to discuss next steps, including a Phase 3 clinical registration trial design for the VERU-111 COVID-19 program. The Company expects that this confirmatory study will have a similar trial design to the Phase 2 study to evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients alive without respiratory failure at Day 29. It is expected that the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have SARS-CoV-2 virus infection and are at high risk for Acute Respiratory Distress Syndrome.
The Company has enough clinical drug supply on hand to complete the Phase 3 clinical study. Once agreed upon by FDA, the Phase 3 is expected to commence in
BARDA has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up.
Investor Event Details
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding the expected timing of studies for the treatment of COVID-19 using VERU-111, the therapeutic potential for VERU-111 to treat COVID-19, the regulatory pathway to secure FDA approval of the Company's drug candidates, the anticipated design and scope of the clinical trial, the anticipated timeframe for clinical studies and FDA submissions, clinical study results including potential benefits and the absence of adverse events, and our resources to conduct clinical trials. Any forward-looking statements in this release are based upon the Company's current plans and strategies and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions. If any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies, including potential delays in the recruitment of patients and their ability to effectively participate in such trials and studies due to COVID-19, and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development and the risk that disruptions at the FDA caused by the COVID-19 pandemic may delay the review of submissions or approvals for new drugs; the risk of a delay or failure in reaching agreement with the FDA on the design of a clinical trial or in obtaining authorization to commence a clinical trial; clinical results or early data from clinical trials may not be replicated or continue to occur in additional trials or may not otherwise support further development in the specified product candidate or at all; our pursuit of a COVID-19 treatment candidate is at an early stage and we may be unable to develop a drug that successfully treats the virus in a timely manner, if at all; risks related to our commitment of financial resources and personnel to the development of a COVID-19 treatment which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties about the longevity and extent of COVID-19 as a global health concern and the possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities may take actions that directly or indirectly have the effect of limiting opportunities for VERU-111 as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the risk that the Company's products may not be commercially successful; risks related to the impact of the COVID-19 pandemic on our business, the nature and extent of which is highly uncertain and unpredictable; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations, including our ability to secure timely grant or other funding to develop VERU-111 as a potential COVID-19 treatment; product demand and market acceptance; competition in the Company's markets and therapeutic areas and the risk of new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; the risk that the Company will be affected by regulatory developments, including a reclassification of products; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of products; some of the Company's products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; the risk that delays in orders or shipments under government tenders or the Company’s
Source: Veru Inc.