Defender Pharmaceuticals Phase 3 Motion Sickness Trial Results Selected for Presentation at 2023 Military Health System Research Symposium (MHSRS)

• Subjects receiving DPI-386 (intranasal scopolamine gel) demonstrated significantly lower incidence of nausea, vomiting or the need for rescue medication in comparison to individuals administered placebo.
  
• MHSRS is Department of Defense’s foremost scientific meeting, drawing approximately 3,500 attendees annually.

ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the previously reported, positive results from its Phase 3 clinical trial with DPI-386 Nasal Gel for prevention of nausea and vomiting induced by motion in adults has been selected for presentation at the upcoming 2023 Military Health System Research Symposium (MHSRS) to be held August 14 -17, 2023 in Kissimmee, FL.

“The selection of our Phase 3 clinical trial results for presentation at this premiere event underscores both the strength of the data and the heavy impact that motion sickness has on the ability to ensure effective military operations,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “Nausea and vomiting associated with motion remains a debilitating factor in military performance that is true regardless of mode of transportation and largely inescapable due to military personnel’s frequent inability to withdraw from the offending stimuli. This trial data being presented at MHSRS effectively linked motion sickness avoidance or improvement with DPI-386 as an effective, alternative means of scopolamine administration, allowing for more rapid vascular uptake and potentially direct absorption into the central nervous system. This was our pivotal Phase 3 trial with DPI-386 in motion sickness, forming the basis for our New Drug Application recently submitted to the US Food & Drug Administration.”

DPI-386-MS-33 was a randomized, double-blind, placebo-controlled Phase 3 study investigating the efficacy and safety of DPI-386 nasal gel for prevention of nausea and vomiting associated with motion. The study included 503 subjects previously screened for experiences with motion sickness that were then dosed with DPI-386 (0.2mg) or placebo before being exposed to open sea conditions. The primary efficacy endpoint was the proportion of subjects who reported no vomiting and no use of rescue medication (e.g., antihistamine) within 4 hours after receiving DPI-386 or to the end of the voyage.

As previously reported, subjects that received DPI-386 demonstrated a significantly lower incidence of vomiting or the need for rescue medication in comparison to subjects administered placebo (p<.0001). The incidence of moderate to severe nausea was also significantly less in the intranasal scopolamine group then in the placebo group (p<.0001). No serious or unexpected adverse events were observed in either the DPI-386 or placebo groups.

Abstract title: Efficacy of Intranasal Scopolamine HBr (INSCOP, DPI-386) for the prevention of vomiting or the need for rescue medication associated with motion.
Presenting Author: Dr. Barry I. Feinberg
Breakout Session: Innovative Technologies to Optimize Warfighters' Performance, and Return to Duty: Individual Wearables, and Neuromodulation
Session Type/Title: Poster Presentation
Abstract Code: MHSRS-23-10223
Date: Tuesday, August 15, Poster Session #2 scheduled for 3:30-5:30 EST
Additional meeting information can be found on the 2023 MHSRS Congress website, https://mhsrs.health.mil/SiteCollectionDocuments/MHSRS23_agenda_F.pdf. The poster will be available on the Company’s website at https://defenderpharma.com/ shortly after the event.

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.

About DPI-386 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.

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.

In addition, the U.S. Navy has designated the DPI-386 new drug application for a “priority review” by the FDA meaning, should the NDA be accepted, the FDA will have six months to review and act on the application as opposed to the typical twelve months for a non-priority review application.

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 has submitted 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.

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.

For media inquiries, please contact [email protected]. For more information about Defender Pharmaceuticals, please visit www.defenderpharma.com.

Source: Defender Pharmaceuticals, Inc.