Intellect Neurosciences Inc. (fka ILNS)

[montanus]

Shire PLC and SHP622

10q May 04, 2016

SHP622 for the treatment of FA
SHP622 is in development for the treatment of Friedreich’s Ataxia and was acquired as part of the acquisition of ViroPharma. This product is a
naturally occurring small molecular weight compound (indole-3-propionic acid) that prevents oxidative stress OX1 by a combination of hydroxyl
radical scavenging activity and metal chelation. Phase 1 studies in healthy adults were completed in 2010. The drug was found to be generally well
tolerated, and the pharmacokinetics revealed that the drug was rapidly absorbed and distributed in the body after oral administration. A Phase 1b
trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHP622 in adults with FA has been completed. SHP622 was
generally safe and well tolerated when administered as single and multiple PO doses. There were no severe treatment emergent adverse events
(“TEAEs”) or deaths reported in either the single or multiple dose groups, and the majority of TEAEs were of mild severity. However, one subject in
the multiple dose group was discontinued due to a possibly related treatment emergent of angina pectoris. Overall, there were no clinically
meaningful differences between SHP622 and placebo or between the single and multiple dose groups. The mean terminal elimination half-life
ranged between 7.36 and 10.33 hours across all dose groups. Intersubject variability appeared to be low to moderate. Shire will continue to analyze
these results and determine an optimal path forward for this program.

http://api40.10kwizard.com/cgi/convert/pdf/Shireplc-20160504-10Q-20160331.pdf?ipage=10913903&xml=1&quest=1&rid=23§ion=1&sequence=-1&pdf=1&dn=1




10q Aug 05, 2016

SHP622 for the treatment of FA
SHP622 is in development for the treatment of Friedreich’s Ataxia (“FA”). Phase 1 studies in healthy adults were completed in 2010. The drug
was found to be generally well tolerated, and the pharmacokinetics revealed that the drug was rapidly absorbed and distributed in the body after
oral administration. A Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHP622 in adults with FA
has been completed. SHP622 was generally safe and well tolerated when administered as single and multiple PO doses. Shire will continue to
analyze these results and determine an optimal path forward for this program.


http://api40.10kwizard.com/cgi/convert/pdf/Shireplc-20160805-10Q-20160630.pdf?ipage=11076706&xml=1&quest=1&rid=23§ion=1&sequence=-1&pdf=1&dn=1