harmAla Submits Pre-IND Dossier for Novel MDMA Analog to FDA
November 2nd, 2022
Psychedelics, Top News
ALA-002 is PharmAla’s lead drug candidate, showing exceptional safety and efficacy in preclinical rodent models
VANCOUVER, British Columbia, Nov. 02, 2022 (GLOBE NEWSWIRE) — PharmAla Biotech (CSE:MDMA) is pleased to announce that it has submitted its pre-IND data meeting package to the US Food and Drug Administration (USFDA) in advance of its pre-IND meeting scheduled for later this month. PharmAla will be requesting FDA feedback on the nonclinical and CMC development plan to support the initial clinical trial for ALA-002.
“As a ‘regulatory-first’ organization, we know that regulators like FDA are rightly concerned with safety of novel medicines. One of the key goals for PharmAla was the development of MDXX compounds that show an improved safety profile compared to generic MDMA,” said Nick Kadysh, CEO of PharmAla Biotech. “We hope that USFDA will see the same potential in our pre-clinical results which we do.”
PharmAla’s goal is to bring ALA-002 into the clinic as a treatment for disorders in adults diagnosed with Autism Spectrum Disorder (ASD). As such, ALA-002 was tested not only in general population research, but also in generally accepted autism mouse models.
“ALA-002 is the first molecule of which we are bringing to USFDA, and we believe it will be an incredibly valuable tool to treat conditions commonly occurring alongside ASD,“ said Dr. Harpreet Kaur, Vice President of Research for PharmAla Biotech. “However, we are hard at work identifying new molecules in the MDXX class that also have clinical promise. Using our proprietary MDXX drug discovery algorithm, we believe we will have even more molecules to bring to regulators in the near future – including the ABA series of non-controlled molecules.”
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