Robert Roebling, MD, Medical Director, UCB, Session IX: Clinical Drugs. For additional sessions, visit and
Here we are thank you so much so my name is robert robling i’m a medical director at ucb and i will talk about staccato alprazolam a drug device combination this is the device i’m sure you can see it here somewhere on the screen which we’re developing as a novel ctvs communication in line with previous presenters i have to say it’s not yet approved or available
Anywhere and all people who have worked on these slides are full-time employees by ucb and the actual device is produced by alexa pharmaceuticals a company actually set up in california and we’re using a model of the device which is a single use single dose delivery system a few years ago a small company engaged the predict was set up to explore whether this
Device drug combination can be used as a cjvs communication and they conducted a phase 2 study in 2019 and based on the promising results of this study ucb quiet engage in 2020 and since we are since then we are developing staccato persona and we’re happy to announce that we have started phase three in december last year next slide please the device has been shown
In this meeting before previously but i’ll show it again for some people who may have not seen it before it’s an inhaler but different from uh typical asthma devices you’ll not find a button on it that would sort of make the uh the drug eject is that there is a sensor built into the device essentially at the rear end of the device and this sensor an air flow
Sensor waits until enough air flows through the device and only then it will trigger a reaction so a breath from the patient will trigger the device and the same breath then will also deliver the drug vaporized by a heat reaction into the lung and then finally the bloodstream and the brain the device can be used by both patients or caregivers and it has been
Successfully administered by caregivers in patients during a seizure with impaired awareness next slide as mentioned before engage has conducted the phase to b study in 2019 since then we have conducted three phase one studies one ethnic uh pk study to allow inclusion of east asians in the program a study in adolescence to allow adolescents in the program and
A study in patients with asthma to assess pulmonary safety of this device and we’re currently in discussions to open up the study to that population in the next time the main program is a double-blind randomized placebo-controlled phase three study and a open labor study that accompanies it next slide please the main study has a co-primary endpoint consisting
Of seizure termination within 90 seconds of drug administration as well as no recurrence of seizures within two hours after drug administration there are further secondary endpoints including further time points of no seizure recurrence including 4 6 and 24 hours and then there is a range of different outcomes essentially we’re trying to assess seizure severity
Or reduction of seizure severity by looking at seizure-related falls injuries strong bites and whether or not a seizure has progressed to generalized or bilateral tonic chronic seizure or even status next slide please here are the main study periods um patients can enter the study if they’ve had four or more prolonged seizures in the last six months before the
Study a prolonged seizure defined as a seizure lasting three minutes or more roughly and once they end this screening we have agreed with the epileptic study consortium that they kindly review the data from all patients on consistency of seizure classification but the main challenge is is to find patients and caregivers where the caregiver can recognize that
A currently ongoing seizure is a prolonged seizure and will most likely last another three minutes or more and that is the time that we want to shorten with our drug compared to placebo so once the patient is approved he or she goes through training and protocol training and device training and is then randomized one to one to receive either staccato placebo or
Staccato um alpha salam and then is essentially sent home because this study happens at home where we are waiting for just one seizure to be treated either sakato or paslam or placebo once that is done and achieved the patient can return to the clinic and then go on to the open label study next slide please this is the key device or actually the full imp kit
For the study you see here on the screen the little blue arrows and the lower arrow points to the foil in which the actual treatment device is located so that’s of course coming first once the drug has been successfully administered which is indicated on this device by a green light turning off the caregiver has to be present and use the timer device to start
Timing then and then measure the time until the cessation of the seizure so this device you can see in the middle here there’s the paper tab to activate it then a button pressed to indicate the stopping of the seizure that contains the raw data of the primary endpoint of the main study and this is happening at home and has to be collected by the caregiver and
We are aware of this is uh putting a bit of burden and pressure on the caregiver and his or her ability to conduct this measurement doing the acute scene of a seizure ongoing and that’s already it in conclusion the cataract brussellum is a breath actuated inhaler an investigation as a potential seizure rescue medication we have happily um started phase three in
December last year study has begun in the us and in japan and we are planning to include the eu in china this year and we are planning to involve about 200 patients with one evaluable treated seizure according to plan with that i thank you for your attention and i’m open to questions
Transcribed from video
Staccato® alprazolam: UCB By Epilepsy Foundation
