Our Project Pipeline
MKL001 & MKL002 Pipeline Overview: Treatment of PTSD
MiHKAL is currently developing the lead candidates MKL001 and MKL002, two undisclosed prodrugs with the specific aim of addressing Post-Traumatic Stress Disorder (PTSD). Currently in the preclinical phase, MKL001 and MKL002 represent a promising advancement in the field of mental health therapeutics.
As MKL001 and MKL002 progress through the preclinical phase, rigorous testing and validation processes are underway to ensure safety, efficacy, and a profound understanding of the compound's mechanism of action.
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Looking ahead, as either MKL001 or MKL002 goes in to clinical phase, the clinical trials will provide valuable insights into the compound's effectiveness in real-world scenarios, bringing us one step closer to offering a transformative solution for individuals grappling with the effects of PTSD. With our candidates, we represent a pioneering approach to address the complexities of PTSD.
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Proof of concept
Validated Approach with Vyvanse method protocol​​​​
As part of our ongoing preclinical research, we have conducted proof-of-concept (PoC) studies to validate the mechanism of action and therapeutic potential of our candidates. By using in vitro digestion assays in human blood, we applied the same methodology that has been used in the development of the prodrug Vyvanse (LDX) by Takeda/Shire. The results confirm that our compounds undergo a comparable enzymatic activation process, with the ability to fine-tune release kinetics, enabling either accelerated or prolonged drug release. This supports their controlled and predictable pharmacokinetic profile and, most importantly, provides direct evidence for their anticipated activation in human.
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