Lacripep Phase II Trial Complete -Findings publish in spring '20

[markt]

In this proposal we define the impact of a novel therapeutic, Lacripep, on maintaining/promoting functional innervation of the cornea and lacrimal gland. Lacripep is the active component of lacritin, a naturally occurring glycoprotein in human tears with prosecretory and mitogenic properties. Recently, we reported reduced levels of lacritin in the tears of human patients with SS and discovered that topical application of lacritin promoted tear secretion, improved corneal epithelial integrity and reduced inflammation in an autoimmune-regulator (Aire)-deficient mouse model of SS-associated ADDE. In our preliminary studies using this model we show Lacripep not only promotes tear production but also rescues innervation of the cornea and lacrimal glands, thus restoring an essential component of ocular homeostasis. Based on these studies, we propose to determine the impact of Lacripep on corneal and lacrimal gland innervation during ADDE development, as well as defining mechanisms by which Lacripep maintains and/or restores innervation.

https://tearsolutions.com/

https://clinicaltrials.gov/ct2/show/NCT03226444

https://www.facebook.com/LacritinAndDryEye/

Phase II concluded last month, findings to be published this spring.  Larger Phase III trials forthcoming.  This is one that I actually participated in.

[Sharon]

Thanks Mark,
Didn't you say it would be approved for SS following phase 2 trials?
If we have to wait for phase 3 to begin, end and be analyzed, FDA approval + marketing we're talking a minimum of 3 years here....  

[markt]

Tearsolutions is working to obtain the orphan drug designation for Lacripep, which allows them to proceed to market faster. (By how much, and under what circumstances I don't know).

Doing so with that designation is contingent on findings (signal of safety/efficacy) from the current trial.

Otherwise...yes, if going the conventional route, yes.  About 2-3 years per Gordon Laurie himself.

You would all do well to follow the Lacripep Facebook webpage.

V/r

Mark

[Sharon]

Thanks for clarifying Mark.