PharmAla's Novel MDMA Mixture Awarded US Patent, Enabling IP Protection And Further Development

The U.S. Patent and Trademark Office (USPTO) has granted PharmAla Biotech Holdings MDXXF a national patent covering the composition of matter of its lead novel compound, ALA-002.  

The Novel Chemical Entity (NCE) is among the group of MDXX-class molecules under development by the biotech. Specifically, ALA-002 is a novel mixture of MDMA enantiomers: 70-80% R-MDMA, and 20-30% S-MDMA. 

"MDMA is relatively unique in that it has two enantiomers that are active, but are active in dramatically different ways," explained the company's Research VP Dr. Harpreet Kaur. "In the brain, these two variants of the molecule have a synergistic effect. In short, the sum of these parts is greater than the whole." 

As the effects of racemic MDMA should be viewed not as one active but as a combination effect, Dr. Kaur says this brings about optimization possibilities. 

"With ALA-002, we believe we have done that difficult work, and have created an improved, novel, next-generation MDMA drug substance formulation," he said.

Preclinical trials showed the molecule's administration "significantly lowered" the incidence of hyperthermia (the major adverse event coming from generic MDMA,) "improved" pro-social effects in the general population and autism-like mouse models, and "reduced" addiction potential.

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The Clinical Stage

PharmAla announced it intends to pursue clinical research with the novel composition, alone or with an out-licensing partner. So far, it has completed a Phase 2 protocol for research targeting social anxiety symptoms in patients with Autism Spectrum Disorder (ASD) together with researchers at the University of Sydney.

Also Read: PharmAla’s Australian JV Cortexa Orders First Commercial MDMA & Psilocybin Shipment 

The company says this is an "Orphan Indication" -meaning there are no FDA-approved treatments available. Nonetheless, the PharmAla team also believes in ALA-002's potential for treating numerous “neurological and neuropsychiatric disorders."

CEO and founder Nick Kadysh says the USPTO's issue of the allowance for granting the ALA-002 patent is the culmination of years of pre-clinical and IP work, and "represents a significant achievement in a relatively crowded IP environment." 

The company intends to use this landmark USPTO allowance to accelerate in other jurisdictions through all practicable means: "PharmAla's IP team has already begun working towards patenting this composition in a number of relevant global markets, with the support of Intellectual Property Ontario (IPON), and we are excited to both defend and build on what we believe is an exceptionally valuable piece of intellectual property," Kadysh concluded.

Further, although the FDA already considers ALA-002 an NCE, the company expects the molecule to potentially be approved by the federal agency "for use as a treatment for any disorder" and "be granted its own Data Exclusivity period."

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