XenoPort gets patent for Fumarate Analog

[Fred]

XenoPort, Inc. (Nasdaq: XNPT) announced today that it was awarded U.S. Patent 8,148,414 for "Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical Compositions Thereof, and Methods of Use." The term of the patent extends until 2029, subject to potential Hatch-Waxman patent term extensions.

The patent is directed to the XP23829 compound, analogs thereof and formulations thereof. A related U.S. patent application directed to therapeutic uses of XP23829 is now pending.

XP23829 is a prodrug of methyl hydrogen fumarate, also known as monomethyl fumarate (MMF). In cell- and animal-based models, MMF has been shown to exhibit immuno-modulatory properties and inhibit damage from oxidative stress.

In XenoPort's preclinical animal studies that compared molar equivalent doses of XP23829 to dimethyl fumarate (DMF), another prodrug of MMF, XP23829 demonstrated a greater degree of efficacy in animal models of both multiple sclerosis (MS) and psoriasis. Toxicology studies conducted in two species showed that XP23829 caused less stomach irritation compared to DMF.

XenoPort intends to file an Investigational New Drug Application (IND) for XP23829 for the treatment of relapsing remitting MS with the U.S. Food and Drug Administration (FDA) in the second quarter of 2012 and expects to initiate human clinical trials later this year.

XenoPort owns all rights to XP23829.

Source: xenoport.com

[Caroline]

Fumarates are normal body owned substances, we produce it ourselves. Give it a strange number, like X1234567, and suddenly it can be patented...
But in the US you can patent anything.

I think I am going for the patent of sucking air into a bubbly mass, take the oxygen out of it by a process and then pushing it out of the mass again.
And I think I am gonna name it:"breathing"

What do you think? Would you take a license?

[Fred]

Fumarates are normal body owned substances, we produce it ourselves. Give it a strange number, like X1234567, and suddenly it can be patented...
But in the US you can patent anything.

I think I am going for the patent of sucking air into a bubbly mass, take the oxygen out of it by a process and then pushing it out of the mass again.
And I think I am gonna name it:"breathing"

What do you think? Would you take a license?

I thought you would like that one.

But you can't just call your new product "Breathing" you will have to come up with a more catchy name to make it sell.

[Fred]

Here is an update:

XenoPort announced today that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults. The trial is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829 administered in both fasted and fed conditions.

Approximately 60 subjects will be assigned to one of five cohorts with each cohort receiving one of four different formulations of XP23829 or placebo. Subjects will receive a single dose of XP23829 or placebo in both a fasted and fed state in randomized order. The trial will assess the blood levels of XP23829, its active metabolite, monomethyl fumarate (MMF), and other potential metabolites. The four XP23829 formulations will include one immediate-release formulation and three extended-release formulations that are designed for possible once-a-day dosing of XP23829.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, said, "Dosing of the first human subject with XP23829 is an important milestone as we work to develop this potential best-in-class fumarate analog. One goal of this study is to verify that XP23829 is efficiently metabolized to produce MMF in the blood. We believe that the MMF pharmacokinetic profiles produced by the different XP23829 formulations administered with and without food will be instructive for the selection of one or more formulations to take forward into future trials."

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