How Enveric Biosciences Is Prepping For Its First IND
A conversation with Joseph Tucker, Ph.D., CEO, Enveric Biosciences
There’s a first time for everything, and now is the time for Enveric Biosciences to submit its first-ever IND to the FDA.
After forgoing a Phase 1 in Australia and deciding to out-license that asset, Enveric now finds itself facing its first IND submission. This time, they’re seeking the OK for EB-003, a novel neuroplastogen designed to be a fast-acting, well-tolerated, and non-hallucinogenic therapy for those with post-traumatic stress disorder (PTSD), treatment-resistant depression, and generalized anxiety.
In this Q&A, Enveric Biosciences CEO Joseph Tucker, Ph.D., discusses how the team is finalizing IND-enabling studies, leveraging both in-house expertise and trusted external partners, and reflecting on lessons learned from earlier programs.
Clinical Leader: When Enveric submitted questions ahead of a pre-IND meeting, the FDA recommended that you instead proceed with an IND application and ask the questions therein. When you got this response, how did you feel?
Joseph Tucker, Ph.D.: We viewed the FDA’s response as very encouraging. The agency essentially said that the questions we had prepared are better addressed in the context of an IND application rather than through a preliminary meeting. To us, that indicates confidence in the strength of our development plan and that we are ready to advance. We see this as a streamlined path forward.
With the encouraging response from the FDA, you’re now heading toward an IND submission. What are the remaining steps you’ll need to take until that submission?
The key steps ahead include completing our IND-enabling toxicology studies, finalizing the clinical trial protocol, and preparing the full IND package for submission. We are in the final stages of our preclinical work, and our regulatory and clinical teams are working closely to ensure all components from pharmacology to CMC documentation are aligned and ready.
And what expertise or resources, internal or external, will you leverage in that time?
We have a highly capable internal team with deep expertise in neurological drug development and regulatory strategy. In parallel, we are leveraging trusted external partners, including specialized CROs for toxicology studies, regulatory consultants with submission experience, and clinical operations experts who will help us prepare for trial execution. These partners bring highly specialized expertise and infrastructure that would be inefficient to build internally, such as GLP-compliant toxicology testing and regulatory submission strategy. We chose them through a careful vetting process focused on experience with neuropsychiatric programs, regulatory credibility, and alignment with our timelines and quality standards.
This combination of in-house leadership and carefully selected partners ensures we can move efficiently and with the highest quality standards.
Are there any new or more complex challenges you’ll face in submitting this IND, as opposed to your submissions for previous assets?
Every development program carries its own unique complexities. For EB-003, the challenge is that we are advancing a first-in-class neuroplastogen with a novel dual mechanism of action. Regulators will naturally want to ensure that EB-003 does not carry hallucinogenic liabilities, so we must take precautions and test explicitly for that. While our prior work advancing earlier assets gave us valuable experience in preparing development packages and coordinating with regulators, EB-003 presents additional scientific and regulatory considerations that we are well positioned to address.
Beyond assessing hallucinogenic potential, additional considerations include demonstrating EB-003’s receptor selectivity and functional activity to confirm its differentiated mechanism, establishing robust translational biomarkers such as qEEG or receptor occupancy to guide dose selection, and conducting abuse liability studies to satisfy FDA expectations for neuroactive compounds. On the regulatory side, we must ensure our toxicology package covers potential CNS-specific safety issues, and we are also preparing for enhanced scrutiny around trial design, including careful patient selection and monitoring protocols that anticipate regulators’ concerns about first-in-class neuropsychiatric therapies.
Outside the FDA, have you received (or solicited) any advice for submitting your first-ever IND? What was it?
Yes, colleagues reminded me to be patient and persistent, because the IND process can take more time and back-and-forth than you expect. At the same time, they emphasized that the best way to make it smoother is by keeping our data packages clear, well-organized, and ready to answer detailed FDA questions up front.
What other assets have you taken into a Phase 1 trial? And what learnings from those drugs and their trials can be used to design this Phase 1?
With EB-373, we advanced through extensive preclinical studies and were preparing for a Phase 1 trial in Australia before deciding to out-license the program. While we did not ultimately initiate the trial, that process gave us meaningful operational learnings in areas such as CMC readiness, toxicology strategy, and clinical trial design. Now with EB-003, we have the opportunity to take those lessons forward and, importantly, to generate first-in-human data ourselves. That will allow us to gain new insights that we haven’t yet had the chance to collect directly.
For example, on the CMC side, advancing EB-373 taught us the importance of locking in a robust, scalable manufacturing process early so there are no surprises as you approach first-in-human studies. We’ve carried that lesson directly into EB-003 to ensure our supply chain and quality systems are in place ahead of the clinic.
You previously planned to conduct a Phase 1 trial in Australia (EB-373 in 2024). Do you anticipate doing the same with EB-003, or will your Phase 1 remain in the U.S.? Why?
With EB-373 we did not quite reach the point of Phase 1 initiation, though we had intended to start that work in Australia before out-licensing the program. We out-licensed EB-373 because it was a stronger fit for a partner dedicated to classic psychedelics, while we focused our resources on advancing non-hallucinogenic neuroplastogens. Along the way, we gained valuable experience in CMC, toxicology planning, and clinical design that we are now applying to EB-003.
For EB-003, our plan is to initiate Phase 1 in the United States, which we believe offers advantages in terms of FDA oversight and long-term development strategy. That said, some of our clinical advisors have suggested evaluating other jurisdictions, including the UK and Canada. The U.S. offers the advantage of early FDA oversight, which is important for long-term alignment, while the UK is attractive for its faster trial initiation and Canada for its efficient regulatory pathway. The consideration is that moving outside the U.S. can add extra steps when transitioning back under FDA review. We are carefully weighing the advantages of each option as we finalize our plans.
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