- Cynapsus Therapeutics
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Cynapsus Therapeutics Inc. (TSX-V: CTH) is a specialty clinical development pharmaceutical company targeting diseases of the brain. Based in Toronto, Canada. Formerly named Cannasat Therapeutics they changed their name to Cynapsus Therapeutics in 2010. [1]
Contents
Company Overview
Cynapsus is a specialty clinical development pharmaceutical company targeting diseases of the brain. Cynapsus has a lower risk Parkinson’s drug candidate, which is a reformulation of an approved drug that can address a moderate to severe patient population. Cynapsus also has a proprietary formulation technology for cannabinoid drug candidates, which may be used to treat neuropathic pain associated with multiple sclerosis and cancer, as well as for nausea/vomiting and appetite stimulation.
Cynapsus's strategy is to grow its portfolio of drug candidates through in-licensing and acquisitions, and to advance projects to Phase 2 proof-of-concept clinical studies. Once the drug candidates are sufficiently derisked, Cynapsus intends to out-license the programs to the appropriate Pharma marketing partners for a combination of upfront, milestone, and royalty payments.
Products
RELIVAR
Relivar, a buccal tablet for symptomatic management of neuropathic pain, contains the active ingredient, dronabinol (or THC). THC has been clinically has been shown to be efficacious for neuropathic pain in numerous clinical trials which have been published in reputable peer-reviewed journals. Undesired psychoactivity associated with higher doses of the oral formulation has limited its utility for this indication.
Relivar aims to deliver the drug in the oral cavity by incorporating it into a tablet that adheres to the gum and releases the drug in the mouth. The benefits are two-fold:
(1) promoting direct absorption through the gums, Relivar can achieve increased bioavailability and reduce the dose required for efficacy
(2) reducing the amount of drug swallowed, and thereby reducing the amount of drug directly metabolized by the liver (first-pass metabolism), also reduces the amount of a potent psychoactive metabolite, Relivar can reduce side effects observed with commercial forms of the drug
Regulatory approval in the United States will depend on a Food and Drug Administration regulatory pathway, based in part on the known safety profile of dronabinol, to be complemented with additional clinical data for use in the new indication of neuropathic pain.
Relivar has successfully completed Proof of Concept Phase I clinical trials for safety and pharmacokinetics (results announced on April 14, 2009) which show proof of buccal absorption, though a combination of increased bioavailability and reduced ratio of the psychoactive metabolite.
APL-130277
APL-130277 is a reformulation of an approved Parkinson’s drug. APL-130277 is a novel oral formulation of an approved drug for Parkinson‘s patients designed to deliver significant clinical benefits over the current marketed treatment. The drug will treat patients with moderate to severe PD and address a significant unmet clinical need as expressed by clinicians and patients. The drug is expected to undergo accelerated approval through 505(b)(2) FDA regulatory pathway with the US FDA and a similar pathway with other international regulatory agencies. This well developed regulatory path could result in a New Drug Approval application being submitted in late 2014 or early 2015. APL-130277 has the potential to address a significant underserved portion of $3 Billion+ Parkinson’s Disease market.
Cynapsus has entered into an agreement with Adagio Pharmaceuticals Ltd. granting Cynapsus the option to execute a proposed exclusive, worldwide agreement to license all intellectual property relating to and issued from continuing development APL-130277.
External links
References
Categories:- Companies listed on the TSX Venture Exchange
- Pharmaceutical companies of Canada
- Companies based in Toronto
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