Reposted from the FoxFeed Blog
Under-the-Tongue Film Strip for "Off" Rescue Moves Closer to Market
Posted by Maggie McGuire Kuhl,
August 16, 2016
Clinical trial news update: Cynapsus Therapeutics Inc. recently announcedresults from the Phase II trial of their listerine-like strip "off" rescue therapy to restore motor function when the effects of levodopa begin to drop. The therapy is now in Phase III testing, and Cynapsus anticipates filing for a new drug application (a formal proposal from the company to the FDA asking for drug approval) in the first half of 2017; the FDA must review all safety and efficacy data in the application before it decides on approval, which can take up to 10 months.
MJFF promoted recruitment of these trials through Fox Trial Finder and is funding a sub-study within the Phase III trial, in which data will be collected from a subset of participants through the use of wearable devices and MJFF's Fox Insight smartphone application (developed in partnership with Intel). Read more below about this therapy and MJFF's support of its development:
The development of a user-friendly "off" rescue therapy recently reached two monumental milestones that will propel it closer to pharmacy shelves.
Cynapsus Therapeutics Inc. is testing a thin-film, under-the-tongue strip (similar to those offered by Listerine for fresh breath) to quickly restore motor function when the effects of levodopa wane. ThePhase I study — funded by The Michael J. Fox Foundation — reported positive results, and the company secured $25 million from investors to support further development.
The thin-film strip is a reformulation of an available drug, apomorphine, that is injected for rescue from "off" episodes. People with Parkinson's disease can go from "on" to "off" when the concentration of levodopa (the primary PD drug) in the bloodstream drops, causing a reemergence of motor symptoms. As patients take levodopa over the long-term, the drug can wear off before the next allotted dosage. Taking more levodopa upon "off" is undesirable since too much of the drug can cause debilitating side effects.
Apomorphine is the only available drug for "off" rescue, but the need for injection discourages use. It also may cause side effects of nausea and vomiting. The under-the-tongue formulation, called APL-130277, may be easier to use and offer longer relief than the injected apomorphine. Initial studies show fewer side effects, as well.
The Phase I study in control volunteers tested how much of the drug from the strip reached the bloodstream and how fast it did so, compared to the established already available injectable. Cynapsus found similar results: the 10mg strip correlates to the profile of the 2mg injection, and the 15mg strip to the 3mg.
Since this study was in control volunteers, they do not know for certain how fast the strip can relieve motor symptoms. However, they do know the level of the drug in the blood that is usually the "on/off" threshold. The strip took 10 minutes to reach that threshold, compared to about six minutes with the injection.
Accounting for the time to fill a syringe and self-inject versus place a strip under the tongue, though, may offset that difference. Furthermore, the effects of the strip on motor symptoms may last longer than the apomorphine from injection.
"Patients can defer taking another dose of levodopa perhaps even longer than they would have scheduled, and we know fewer levodopa is a good thing in the long run," said Albert Agro, PhD, chief medical officer at Cynapsus.
A separate study from Cynapsus of a 25mg dose of APL-130277 showed faster time to reach the "on/off" threshold and longer efficacy.
Their next step is to test these doses in people with Parkinson's. The study is still being planned. When sites start recruiting, the details will be listed on Fox Trial Finder.
The $25 million follow-on investment for this study is a testament to the MJFF de-risking model, supporting early-stage research to make these projects more attractive to larger funders.
"We look forward to initiating the efficacy program in patients suffering from Parkinson's disease with debilitating motor complications," Dr. Agro said.
Said Anthony Giovinazzo, CEO of Cynapsus, "Our partnership with The Michael J. Fox Foundation is very important to us as not only does it provide credibility, but they have the means to help us accelerate our recruitment."
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