Kalytera’s lead program has recently completed three Phase IIa studies evaluating the safety and efficacy of short term use of cannabidiol (“CBD”) in the prevention of acute Graft versus Host Disease (“GvHD”), prolonged use of CBD in the prevention of acute GvHD, and prolonged use of CBD in the treatment steroid-refractory Grade III-IV acute GvHD.
- Prevention of Acute GvHD
- Treatment of Acute GvHD
- Acute Resuscitation of Severe Traumatic Brain Injury (“TBI”)
Kalytera’s follow-on pipeline of CBD prodrugs was designed to specifically modify physiochemical properties and functionality of CBD. These modifications are intended to enhance regional therapy and enable bifunctional therapy. We anticipate that our prodrug pipeline will be well tolerated, as CBD exhibits an unremarkable safety profile in the clinic.
Prodrugs are covalently-modified derivatives of the pharmacologically active agent and must undergo transformation in vivo in order to release the active agent CBD. This approach is now a well-established strategy to improve the pharmacokinetic and physiochemical profile of potential drugs, and thereby increase their efficacy, reduce their susceptibility to metabolism, and minimize toxicity.
- Sepsis-induced Acute Renal Failure (“ARF”)
- Severe Traumatic Brain Injury (“TBI”)
- Adult Respiratory Distress Syndrome (“ARDS”)
- Ulcerative Colitis (“UC”)