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Like All Things CNS, It’s Not So Easy
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F I N A L T R A N S C R I P T
Dec. 18. 2008 / 8:30AM, ADLR - Adolor Corporation Investor Update Call
Just completed two Phase IIa trials on ADL5859 to explore safety and efficacy in two
distinct models of pain: diabetic peripheral neuropathy as a model of neuropathic
pain; and rheumatoid arthritis as a model of chronic inflammatory pain. Neither
showed statistical significance on efficacy measures, but were safe and well
tolerated. The company is now evaluating the current formulation and considering
an increase in exposure and decrease in variability before initiating additional studies
in patients.
For ADL5747, our second Delta Agonist, we recently have completed enrollment in a
multiple ascending dose Phase I trial in 32 healthy volunteers. To date, we have not
observed any dose-limiting toxicity or clinically significant adverse events. Pfizer and
we intend to initiate a proof of concept trial of 5747 in osteoarthritis during the third
quarter of 2009 and in neuropathic pain in the fourth quarter of 2009.
To close the Delta section of this call, it is our interpretation that the results of
these preliminary Phase IIa trials of ADL5859 were inconclusive as to efficacy.
Pfizer and we continue to believe that Delta Agonists represent an exciting
new class of drugs to treat pain and are in agreement that both ADL5859 and
ADL5747 merit continued clinical development.
© Defined Health, 2009
Pain Insight Briefing