ST. LOUIS, MO—Jun. 5, 23—Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced positive results from the Company’s pivotal phase III clinical trial of intranasally administered DPI-386 Nasal Gel (scopolamine HBr), which is in late-stage development for the prevention of nausea and vomiting induced by motion.
DPI-386 Nasal Gel achieved the primary endpoint in this recently completed, confirmatory Phase III clinical trial, DPI-386-MS-33, a randomized, double-blind, placebo-controlled Phase 3 study of the efficacy and safety of DPI-386 Nasal Gel versus placebo. In this study, all participants were exposed to motion on an ocean-going vessel. The primary endpoint in this study was assessment of the effectiveness of DPI-386 (defined as “Completer Response”) in reducing the proportion of participants who reported no vomiting and who did not request rescue treatment (e.g., antihistamine) in comparison with placebo. Positive results demonstrated that the proportion of participants in the DPI-386 treatment arm who did not report vomiting and did not request rescue treatment was significantly greater (p<0.0001) than participants receiving placebo. Reduction in Moderate-Severe Nausea with DPI-386 was also demonstrated to be statistically superior to placebo (p<0.0001) during the entire trial period.
“The results from this confirmatory pivotal Phase III trial DPI-386-MS-33 demonstrated that DPI-386 effectively prevents nausea and vomiting induced by motion,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “This marks an important milestone for Defender and completes all data needed for submission of our NDA.”
Eight parameters of performance and cognitive function (concentration, mood, alertness, memory, hand-eye coordination, balance, reaction time (speed), and overall performance) were also self-assessed (participant reported) before dosing and every 30 minutes thereafter during the study. The rate for each of the eight parameters were observed to be significantly lower for DPI-386 relative to placebo during the assessment period.
DPI-386 was well-tolerated by study participants with no serious adverse events. Overall, adverse events were more common in the placebo group compared to the DPI-386 group. The most common adverse events that occurred in ≥ 5% of patients were headache, somnolence, fatigue, and dizziness. Only somnolence was reported more in participants taking DPI-386 compared with those in the placebo group.
Defender is planning to publish the full results from the study in the near term.
Intranasal Scopolamine Development Program
Defender is working with the United States Naval Medical Research Unit (NAMRU-D) and the National Aeronautics and Space Administration (NASA) on its intranasal scopolamine development program that is focused on specific military personnel and astronauts.
To date, more than 1,300 patients have participated in Defender clinical studies, including over 500 participants in the recently completed DPI-386-MS-33 study. Given the successful outcome of DPI-386-MS-33, Defender plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) for DPI-386 Nasal Gel for the prevention of nausea and vomiting induced by motion.
Defender is also developing intranasal formulations designed to treat a wide variety of indications. We believe these new products have the potential to help safeguard health across civilian and military populations.
About Motion Related Discomfort
Certain motions cause discomfort in individuals while engaged in a variety of leisure or travel related activities. Most forms of travel, whether on land, in the air, or on the water, can trigger symptoms such as nausea and vomiting (example: flying, boating/fishing, car, bus, and train). Symptoms induced by motion can also have a detrimental impact on the ability of various military personnel and astronauts to perform assigned duties, potentially impacting readiness and negatively impacting resources. Motion related discomfort is a common and transient response to unfamiliar or unnatural motion or contradictory spatial sensory information, resulting in decrements to performance of tasks, pallor, cold sweating, nausea and vomiting. Prolonged exposure to certain motions may induce sopite-related symptoms such as loss of drive and concentration, drowsiness, sleepiness, apathy, depression, and a feeling of impending doom.
About Intranasal Scopolamine
In pharmacokinetic studies in healthy volunteers, scopolamine administered via an intranasal gel demonstrated rapid absorption, showing that intranasal drug delivery can offer healthcare providers an important alternative administration route, with potential benefits including ease of use and rapid onset of action.
About Defender Pharmaceuticals, Inc.
Defender Pharmaceuticals, Inc., located in St. Louis, MO, is a privately held life sciences company focused on discovering, developing and commercializing medicines to help safeguard health across civilian and military populations. Our work with the Department of Defense, NASA, the Department of Veterans Affairs, and other institutions advance our mission to improve the health of patients and help make the world a more secure place.
Cautionary Note on Forward-Looking Statements
Various statements in this press release, including but not limited to statements regarding Defender’s plans to continue the intranasally administered scopolamine HBr development program and pursue FDA approval, are forward-looking statements under securities law. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding our product candidates and the development thereof, such as the Company’s intranasal scopolamine motion development program; the therapeutic potential of our intranasally administered scopolamine HBr product candidate; the Company’s regulatory plans and timelines for intranasally administered scopolamine HBr, including our planned submission of a New Drug Application for intranasal scopolamine and the indication(s) expected to be pursued in the near term. The process by which investigational therapies, such as intranasal scopolamine, could potentially lead to an approved product is long and subject to highly significant risks. Other risk factors relevant to Defender include our reliance on third-party contract research organizations; the reliance of Defender on contract manufacturers to supply its products for research, development and commercialization and the risk of supply interruption from such contract manufacturers; the timing, plans and reviews by regulatory authorities of marketing applications such as NDAs for intranasally administered scopolamine HBr; alignment with the FDA on the regulatory pathway to approval for intranasally administered scopolamine HBr; market acceptance for approved product; competition; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated during development and following commercialization; and general business, financial, and accounting risks and litigation. The forward-looking statements contained in this press release reflect Defender’s current views with respect to future events as of the date of this press release, and Defender does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Source: Defender Pharmaceuticals, Inc.