Still Dr. B: Psoriasis: 3 million in U.S. with
Post# of 72447
Posted On: 11/15/2016 10:36:13 AM
Still Dr. B:
Psoriasis: 3 million in U.S. with moderate to severe psoriasis. People suffer discrimination and humiliation, really want to do something to solve it.
Slide: shows chemical structure. Glycolic acid component --abacavir glycovate. PRINS reduction -- RNA that increases with stress.
Composition of matter patent is good through 2030's. Can use Ziagen as reference drug, accelerate development by the 505B2 pathway which lets us look at long term safety in regards to Abacavir. Abacavir is a major metabolite of P.
Have achieved success in pre-clinical trial, has advantage of oral dosing.
When P is metabolized, it's metabolized by breakage of ester linkage to form glycolic acid, and Abacavir. Abacavir has no benefit for psoriasis (as Ziagen) -- COULD NOT BE BENEFICIAL against psoriasis if just given as Ziagen. Take that, bashers (my editorial comment).
Slide showing Phase 1 study, efficacy at various doses or placebo. 9 sites, 115 subjects. Efficacy, safety, pharmokinetics were studied.
(We already know this stuff about the efficacy)
IGA scores progressively lowered over 12 weeks. Less psoriasis activity, with clear and almost-clear groups at end of trial. 35% of all patients in 200 mg met that endpoint. Looked at IGA3 (moderate) group, endpoint was met in 46% of patients.
Chart showing IGA3 (moderate) group. that's about 70% of patient population.
Yellow line is IGA1, almost clear, Red line is IGA0, clear. In time, moderate psoriatics join the mild group. They continue to improve over the course of the trial.
By 6 weeks the bulk of the response has already happened. A relatively early response, which is always well received by patients.
1 serious adverse event in the 50mg group, none in higher dosage groups. Not a dose relationship. PK results showed dose-dependent increase in drug exposure.
Compelling for Phase 2A study, lead us to believe we'll see very favorable results in next study.
Impressive results in 200mg group. Saw improvement as early as 2 weeks. Generally well-tolerated, 2/3 of subjects in 200 mg group had favorable responses. So will investigate in moderate to severe population. Have just begun Phase 2B, 200 and 300 mg doses. PASI 75 score is main endpoint. this is what's needed for Phase 3 studies.
Currently enrolling patients in randomized double-blind trial. 189 subjects anticipated. 12 weeks, interim readout in 2Q 2017.
Psoriasis: 3 million in U.S. with moderate to severe psoriasis. People suffer discrimination and humiliation, really want to do something to solve it.
Slide: shows chemical structure. Glycolic acid component --abacavir glycovate. PRINS reduction -- RNA that increases with stress.
Composition of matter patent is good through 2030's. Can use Ziagen as reference drug, accelerate development by the 505B2 pathway which lets us look at long term safety in regards to Abacavir. Abacavir is a major metabolite of P.
Have achieved success in pre-clinical trial, has advantage of oral dosing.
When P is metabolized, it's metabolized by breakage of ester linkage to form glycolic acid, and Abacavir. Abacavir has no benefit for psoriasis (as Ziagen) -- COULD NOT BE BENEFICIAL against psoriasis if just given as Ziagen. Take that, bashers (my editorial comment).
Slide showing Phase 1 study, efficacy at various doses or placebo. 9 sites, 115 subjects. Efficacy, safety, pharmokinetics were studied.
(We already know this stuff about the efficacy)
IGA scores progressively lowered over 12 weeks. Less psoriasis activity, with clear and almost-clear groups at end of trial. 35% of all patients in 200 mg met that endpoint. Looked at IGA3 (moderate) group, endpoint was met in 46% of patients.
Chart showing IGA3 (moderate) group. that's about 70% of patient population.
Yellow line is IGA1, almost clear, Red line is IGA0, clear. In time, moderate psoriatics join the mild group. They continue to improve over the course of the trial.
By 6 weeks the bulk of the response has already happened. A relatively early response, which is always well received by patients.
1 serious adverse event in the 50mg group, none in higher dosage groups. Not a dose relationship. PK results showed dose-dependent increase in drug exposure.
Compelling for Phase 2A study, lead us to believe we'll see very favorable results in next study.
Impressive results in 200mg group. Saw improvement as early as 2 weeks. Generally well-tolerated, 2/3 of subjects in 200 mg group had favorable responses. So will investigate in moderate to severe population. Have just begun Phase 2B, 200 and 300 mg doses. PASI 75 score is main endpoint. this is what's needed for Phase 3 studies.
Currently enrolling patients in randomized double-blind trial. 189 subjects anticipated. 12 weeks, interim readout in 2Q 2017.
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