- First study evaluates DPI-386 alone and in combination with sensory augmentation to effectively mitigate motion sickness and improve task performance, in comparison to placebo.
- Second study evaluates the feasibility and efficacy of administering DPI-386 in operational field settings, with both astronaut and ground-control subjects, when exposed to provocative motion.
ST. LOUIS, MO—(BUSINESS WIRE)—Oct. 24, 23—Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced it has initiated two Phase 2 clinical studies, in collaboration with investigators from the United States National Aeronautics and Space Administration (NASA), investigating the ability of DPI-386 (intranasal scopolamine gel) to mitigate G-transition induced motion sickness and enhance sensorimotor performance.
“Positive results from either or both of these clinical studies will bolster the growing body of data supporting the use of DPI-386 to prevent the symptoms associated with motion while also potentially expanding the breadth of applications for which intranasal scopolamine gel can serve this purpose,” remarked Dave Helton, Defender’s Chief Scientific Officer. “We are excited and eager to get enrollment in these studies underway as soon as possible, in anticipation of results in second quarter 2024.”
The first of these Phase 2 clinical trials is a randomized, double-blind, placebo-controlled, cross-over investigation comparing motion sickness symptom severity and time to severe malaise in 30 subjects, age 18 to 65 years, during exposure to simulated wave motion on a 6DOF platform inside of a crew capsule mockup. This trial will compare four conditions of DPI-386 with sensory augmentation, DPI-386 without sensory augmentation, placebo control with sensory augmentation, and placebo control without sensory augmentation. Subjective side effects and performance on the Psychomotor Vigilance Test (PVT) will also be obtained.
The second of these Phase 2 clinical trials is an open-label, non-randomized evaluation of the feasibility and efficacy of self-administered DPI-386 in operational field settings for approximately 80 astronaut and ground-control subjects, age 18 years or older, exposed to provocative motion as part of their assigned duties. Astronaut participants may choose to test DPI-386 during provocative preflight training exercises as well as to prevent or treat symptoms associated with motion during the launch and/or landing mission phases. Examples of provocative motion for ground-control subjects include motion simulations, parabolic flights or Orion capsule recovery operations. All participants will initially be required to test DPI-386 during a training session to monitor for adverse side effects. Participants will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. Investigators will also require field “control” subjects, not administered DPI-386, to comment on alternative countermeasures used and their effectiveness. Astronaut recruitment will be from among participants in free-flier missions (e.g., SpaceX, Inspiration 4, Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station.
Both trials are being led by primary investigator Scott J Wood, PhD of NASA, and Neuroscience Laboratory Principal Investigator. Additional information on both clinical trials can be found at clinicaltrials.gov.
Acknowledging the Contributions of Dr. Lakshmi Putcha
The design and development of the protocols for each of these studies would not have been possible without the contributions of NASA pharmacologist Dr. Lakshmi Putcha. Dr. Putcha passed away in 2015 but left a legacy at NASA that paved the way for innovative research like that described in these two studies that continues to benefit space travelers to this day. Dr. Putcha served as chief pharmacologist at NASA-Johnson Space Center and technical manager of the Pharmacotherapeutics Laboratory at the Johnson Space Center. As the only clinical pharmacologist at NASA, Dr. Putcha was responsible for directing and conducting the research and development program for optimizing pharmacotherapeutics in space. Her contributions include significantly expanding knowledge of the wide-ranging effects of space flight on humans, as well as resolving critical human health and safety issues for all mission, including ones to Mars.
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. Additional information can be found at defenderpharma.com.
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.
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.
Source: Defender Pharmaceuticals, Inc.