Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome - MarketWatch
MIAMI, Feb 08, 2021 (GLOBE NEWSWIRE via COMTEX) -- - 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 April 2021 with clinical results expected in calendar Q4 2021 -
- Company to host an investor conference call at 9:00 am ET today to discuss results and next steps -
MIAMI, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced positive efficacy and safety results from a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS) from SARS-CoV-2.
"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 Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Due to the urgency of the global pandemic and need for more effective treatment options for patients, we are duty-bound to pursue this indication, even though it has not been the primary focus of Veru. We have the resources to conduct a Phase 3 trial without impacting our cancer drugs' clinical development. We look forward to our upcoming discussion with FDA concerning the regulatory and clinical development steps to move VERU-111 for COVID-19 forward."
"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 Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted the trial at Memorial Hermann Memorial City Medical Center in Houston TX. "The results of the Phase 2 trial were strengthened by the strict parameters in place, which included a blinded, placebo-controlled, randomized study that also allowed standard of care for both the treated and the placebo groups in hospitalized patients at high risk for ARDS."
Trial Design:
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 the United States. Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled. Subjects received an 18mg dose of VERU-111 or placebo, as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients alive without respiratory failure at Day 29. Respiratory failure was defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, and/or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation.
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 greater-than or equal to5 (hospitalized; on oxygen) at baseline: Treatment failures were 11% for VERU-111 versus 54% for placebo; p=0.04.
Secondary Endpoints
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 greater-than or equal to3 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 April 2021 and conclude by the fourth quarter of calendar 2021. We will seek funding from The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) and other agencies to fund the estimated amount of commercial drug to supply the needs of the US population, assuming confirmatory positive clinical results and FDA approval.
BARDA has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up.
Investor Event Details
Veru Inc. will host a conference call today at 9:00 am ET to discuss the positive clinical results from the Phase 2 trial. Interested parties may access the call by dialing 1-412-902-6703 and entering the participant access code number 1310812 to enter the conference. The call will also be available through a live audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available later that day by dialing 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S., replay access code 10152256, for one week. |
