Psychedelic: Enveric announces EB-003 manufacturing milestones

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on manufacturing milestones, a shipment completion and an ANDA sale.

ENVERIC COMPLETES EB-003 MANUFACTURING MILESTONES: On Thursday, Enveric Biosciences (ENVB) announced progress in the chemistry, manufacturing, and controls development of its lead candidate, EB-003. Important steps in scaling production and preparing the drug for required regulatory activities have been achieved, advancing EB-003 toward the critical milestone of initiating human clinical trials. As part of its CMC program, Enveric recently completed key activities including identifying and producing a pharmaceutically compatible salt form designed to potentially improve drug effectiveness and stability, developing and implementing a scalable, reproducible synthetic route for EB-003 suitable for both current and future manufacturing needs and producing a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support upcoming Investigational New Drug application activities, including GLP toxicology studies and drug product formulation work.

“These manufacturing and formulation milestones are essential for positioning EB-003 to enter clinical development,” said Joseph Tucker, CEO. “By demonstrating that EB-003 can be synthesized at scale in a pharmaceutically acceptable salt form and manufactured in kilogram quantities, we are reducing development risks and accelerating our path to human trials. These advancements, combined with our preclinical data, continue to build momentum for EB-003 as we move closer to first-in-human studies.”

PHARMALA COMPLETES LANEO MDMA SHIPMENT: PharmAla Biotech Holdings (MDXXF) announced Thursday that it has completed its shipment of LaNeo MDMA to Johns Hopkins University from its newly onboarded distribution site in the United States.

“Our delivery to Johns Hopkins represents a new day for MDMA research in the United States, especially for those investigator-sponsored clinical trials who have struggled with investigational medical product sourcing in the past,” said Nick Kadysh, CEO. “We believe that ensuring a supply for PharmAla’s large and growing pool of Clinical Trial customers will ensure that data on MDMA’s efficacy in the treatment of a number of disorders becomes widely available – and will speed the day that MDMA is accepted worldwide as a powerful treatment not just for PTSD, but for a range of disorders.”

PHARMATHER ANNOUNCES SALE OF KETAMINE ANDA: PharmaTher (PHRRF) announced Wednesday that it has entered into a definitive asset purchase agreement for the sale of its Abbreviated New Drug Application for Ketamine Hydrochloride Injection USP to a global pharmaceutical company specializing in sterile injectables and complex generics. Under the agreement, PharmaTher will receive a confidential upfront cash payment at closing and is eligible for milestone payments based on cumulative sales thresholds, along with ongoing profit-sharing for a period of seven years following the first commercial sale. In total, the agreement contemplates potential consideration of more than $25M. The agreement is subject to customary closing conditions, including required regulatory notifications, with the effective date of closing expected to occur in the near term.

“This transaction validates the significant value embedded in our ketamine assets,” said Fabio Chianelli, CEO. “We are excited to announce this agreement with a leading global sterile-injectables company, structured to allow PharmaTher to share in the upside of future sales of the growing ketamine market. Importantly, it also enables us to leverage the foundation we built with our ketamine program to advance our proprietary next-generation therapies, which we believe represent multiple high-value opportunities for both patients and shareholders.”

On Thursday, the company said it plans to concentrate on several key initiatives aimed at realizing the commercial potential of its ketamine portfolio over the next six months. The company is actively pursuing new global partnerships that could provide additional non-dilutive funding and accelerate the development and commercialization of its ketamine-based products. PharmaTher is planning meetings with the U.S. FDA to define an expedited clinical and regulatory path for ketamine in CRPS and to seek agreement on a Phase 3 study design for Parkinson’s disease. Both the CRPS and Parkinson’s programs, if supported by positive FDA guidance and outcomes, would be positioned as attractive candidates for potential partnerships with larger pharmaceutical companies, as well as for the company’s ketamine microneedle patch and wearable pump programs.

NRX PHARMACEUTICALS REFILES ANDA FOR KETAFREE: NRx Pharmaceuticals (NRXP) announced Monday the re-filing of its ANDA to the U.S. Food and Drug Administration for KETAFREE, its preservative-free intravenous ketamine formulation, for use in all existing approved indications. The filing follows FDA grant of approval of its Suitability Petition for NRx’s proposed strength of preservative-free ketamine. The company previously filed a citizen’s petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for IV use. The formulation filed under the ANDA is distinct from that used in the New Drug Application, for which the company has received Fast Track Designation for Treatment of Suicidal Ideation in Depression, including Bipolar Depression. The company anticipates submitting clinical trial data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy. Should both the ANDA and the NDA be approved, the resulting commercial products would have different, non-substitutable product numbers and different commercial paths.

“We appreciate FDA’s rapid response to our suitability petition and look forward to advancing our preservative-free ketamine presentation to market,” said Jonathan Javitt, CEO. “KETAFREE is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility, and to reshore the manufacture of a strategically-important drug to the US. We have filed a US patent on our novel, preservative-free formulation, which anticipates three years of room-temperature shelf stability.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Clearmind (CMND), Compass Pathways (CMPS), Cybin (CYBN), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL) and Silo Pharma (SILO).