Enveda Announces US FDA IND Clearance and First Patient Dosed in Phase 1 Trial of ENV-308, a First-in-Class Oral Therapy for Obesity; Appoints Nadeem Sarwar, Ph.D., MPharm, MPhil, to Lead Metabolic Disease Strategy

ENV-308 is a first-in-class, once-daily oral therapy designed for chronic weight management, emphasizing high-quality weight loss with muscle mass preservation and durable long-term maintenance

Phase 1 trial initiated in the US with the first patient dosed following US FDA IND clearance

Nadeem Sarwar, Ph.D., MPharm, MPhil (former Co-Founder and Head of the Transformational Prevention Unit at Novo Nordisk) joins as SVP to advance the Company’s pipeline focused on metabolic longevity

BOULDER, Colo.--(BUSINESS WIRE)--Enveda, a clinical-stage biotech company pioneering the discovery and development of a new generation of small-molecule drugs derived from life’s chemistry, today announced three major milestones advancing its metabolic disease portfolio. The US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ENV-308, allowing Enveda to initiate a Phase 1 clinical study where the first participant was dosed last week.

Concurrently, Enveda announced the appointment of Nadeem Sarwar, Ph.D., MPharm, MPhil, as Senior Vice President (SVP) & Global Head of Disease Prevention and Metabolic Disease Strategy.

The Path to Maintenance

ENV-308 is being developed to address a central need in obesity care: durability. While current medicines have raised expectations for weight loss, many patients still face challenges regarding tolerability, convenience, and staying on therapy long enough to preserve benefits.

Enveda is designing ENV-308 as a once-daily oral option that can serve as a safe, convenient therapy suitable for use across the continuum, from earlier intervention to long-term chronic weight management following induction with GLP-1s or lifestyle changes – just like how statins were used in cardiovascular disease.

“Obesity is a chronic, multi-system disease, and long-term success at population scale will require therapies engineered for durability, tolerability, and everyday practicality,” said Viswa Colluru, Ph.D., Chief Executive Officer, with Enveda. “Unlocking metabolic longevity is humanity’s next moonshot. This is not about simply losing weight; it is about designing a future where we prevent disease before it starts, preserve vitality, and extend healthy lifespan at population scale. ENV-308 is our first step toward that reality. With the clearance of our IND and the dosing of our first patient, we are moving closer to providing a practical, oral solution for sustainable metabolic health.”

ENV-308 Phase 1 Study Design and Preclinical Profile

The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and early pharmacodynamic signals of ENV-308. The program is supported by robust preclinical data suggesting a profile optimized for chronic use, including:

• Preservation of muscle mass driving high-quality weight loss
• Maintenance efficacy that sustains weight loss regardless of the induction method or target weight
• Favorable tolerability with signals consistent with reduced nausea potential, supporting goals for chronic use
• Comorbidity-relevant benefits observed across multiple preclinical readouts

Leadership for a New Era of Prevention and Long-Term Maintenance

To guide this expanding portfolio, Nadeem Sarwar, Ph.D., MPharm, MPhil, joins Enveda with deep expertise in human genetics, translational science, and metabolic strategy. He previously served as Corporate Vice President and Head of the Transformational Prevention Unit (TPU) at Novo Nordisk, where he led efforts to predict and prevent obesity. Prior to that, he held senior leadership roles at Eisai (President, Eisai Center for Genetics Guided Dementia Discovery) and Pfizer (Head of Cardiometabolic Genetics).

In this role, Dr. Sarwar will lead global strategy across prevention, earlier metabolic risk intervention, and durable long-term solutions, ensuring clinical development and evidence generation align with how patients, clinicians, and health systems must manage metabolic disease over time.

“The next chapter of metabolic health will be defined by what patients can sustain for years, not just months,” said Nadeem Sarwar, SVP & Global Head of Disease Prevention and Metabolic Disease Strategy, with Enveda. “The promise of metabolic longevity is prevention-first care that preserves healthspan and helps people stay well for decades. ENV-308’s unique preclinical profile supports this ambition, including the opportunity to deliver effective solutions at the scale needed for global health equity. I am excited to help build the evidence required to bring a durable, real-world and scalable solution to people and patients.”

About ENV-308

ENV-308 is an investigational, oral, once-daily small molecule in development for obesity and metabolic disease. In preclinical studies, it has demonstrated body-weight loss with muscle preservation, a favorable tolerability profile with reduced nausea potential, and broad metabolic and comorbidity-relevant benefits.

About Enveda

Enveda is a biotechnology company that learns from life’s chemistry to create better medicines faster. Enveda uses AI-powered tools to identify and characterize a wide range of molecules produced by living organisms, the vast majority of which have never been explored by science, creating a database of chemical biodiversity: the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life’s evolved solutions to address today’s most pressing medical needs. For more information, visit enveda.com.

Investor Contact:
Soumoditya Dey
VP, Corporate Development and Investor Relations
soumoditya.dey@enveda.com

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