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Lawyer's Rezolute on track for late-stage studies for hypoglycemia and diabetic macular edema treatments

Analysis  |  By Robin Robinson  
   April 26, 2023

As an advisor to hundreds of therapeutic and tech startups over the years, this innovator observed both good and bad business processes.

Nevan Elam, JD, CEO and founder of Rezolute, practiced law for more than two decades, working as an advisor to companies in the life sciences and tech industries, when his real passion emerged from the experience. His calling was not driven by high-tech solutions and corporate law, but rather children, in particular, children with rare diseases in need of new treatments.

As an advisor to hundreds of therapeutic and tech startups over the years, Elam observed both good and bad business processes, which prepared him well to launch his own biopharma.  

"I spent a good number of years as a partner in a law firm in Palo Alto, and I saw what works and a lot of what doesn't. And it was there that I also discovered what my passion really was, and it wasn't about all things bits and bytes. Working with therapeutic company clients was the most personally rewarding to me because they were making a difference."

The father of three says there's nothing more impactful for him than working to help children.

"If you can actually make a difference in a child's life, there's nothing like it," he says.  "I witnessed that in my prior roles and that spurred my interest in creating Rezolute."

Elam established the clinical stage biopharmaceutical company in 2010 with a focus on developing transformative therapies for rare and metabolic diseases, specifically therapies targeting congenital hyperinsulinism and diabetic macular edema therapeutics (DME).  

Saving children from hypoglycemic brain damage

Congenital hyperinsulinism is a genetic disorder in which the insulin cells of the pancreas secrete too much insulin. Rezolute's lead candidate, RZ358, is in Phase 2b development. In 2022, the RIZE study exceeded expectations for correction of hypoglycemia, including a highly significant reduction of  approximately 75% in hypoglycemia events by blood glucometer. "The treatment substantially corrects the hypoglycemia that these children have experienced," Elam says. "We're poised to start Phase 3 of RIZE this year, which is very exciting for families, physicians, key opinion leaders and all of us at Rezolute."

According to NORD, congenital hyperinsulinism (HI) is the most frequent cause of severe, persistent hypoglycemia in newborns, infants, and children. In most countries it occurs in approximately one out of 25,000 to one out of 50,000 births. About 60% of babies with HI are diagnosed during the first month of life. An additional 30% will be diagnosed later in the first year and the remainder after that. With early treatment and aggressive prevention of hypoglycemia, brain damage in these children can be prevented.

"RZ358 will enter its Phase 3 program mid-year this year and is expected to be complete and announced in the first half of 2025," Elam says.

No more needles in the eye for Diabetic Macular Edema

Rezolute's DME candidate, RZ402, is a plasma kallikrein inhibitor in a pill form instead of a shot that would radically change the treatment of patients with DME. The disease is treated historically with a monthly anti-VEGF (vascular endothelial growth factor) injection into the eye. This uncomfortable method of delivery reduces patient adherence and can affect adequate dosing.

"Our exciting oral therapy for DME will be a potential game changer," Elam says. "We just started a Phase 2 study in the US, and we'll be doing it at 25 sites this year, and with 100 patients for proof of concept to demonstrate that a daily tablet can actually reduce the swelling in the macula and also prevent a vascular leakage. If we're right, it'll have a tremendous impact on how we actually treat these patients."

The study should be completed this year and Rezolute plans to announce the results in Q1 of 2024.

"With our success in our clinical studies to date, we've been fortunate to raise enough capital in the last year to be able to fund both those programs," Elam says. "So now it's all about execution."

Leadership skills and team building

Before Elam launched Rezolute, he knew what kind of leader he wanted to be as a CEO, and he knew what kind of team he wanted to build. Throughout his career, he had encountered egocentric leaders and that was a model did not work for him. He decided he would get to know his employees as individuals, work to understand their motivations, and allow them to contribute in the best way possible for both parties. At Rezolute, he has intentionally created a collaborative work environment where individuals have the freedom to voice their opinion, excel in their expertise, and be included in discussions.

"I pride myself on building a company that's really focused on the common mission and goal but is also an environment where individuals have the freedom to contribute and are encouraged to be forthright and bring their expertise to the forefront," he says. "This is how you create a good team and retain, as well as excel, with individuals who love where they work. We've been very successful at building that type of team." 

Reflecting on his own leadership style, Elam says the most effective leaders are those that work in the spirit of collaboration,  "where egos are left at the door."

"Part of the job as a CEO, especially with respect to the senior leaders, is doing your best to understand the individuals," he says. "That's  how I operated as a senior executive, even before becoming a CEO and a founder. And definitely the way I operate as a CEO today."

Elam manages the stress and responsibilities of running the biopharma by taking three- to four-hour bike rides through the redwoods and mountains near his California home. "Staying active is my superpower. It's my therapy," he says. Each ride averages about 40 miles at about 5,000 feet of elevation, over the hilly range that runs along the Pacific Ocean.

"It's a pretty intense ride but so beneficial in terms of getting outside, seeing the redwoods, seeing the ocean and getting amazing exercise," he says. "My favorite thing is to get under the 2000- year-old redwood trees; those giants put everything into perspective."

Elam also spends time contemplating the works of Nietzsche, Plato, Aristotle, Kant and others. "Exploring philosophy is a very different hobby than probably most folks have who are in drug development, but I am fascinated by what makes us human and why it is we do what we do."

And it is that type of deep thinking and seeking understanding that brought Elam and his team at Rezolute to continue advancing toward two major milestones in the coming years: the approval of RZ358 and RZ402. These novel treatments could fill an unmet need that would have a long-term impact on the lives of patients with diabetes and children with congenital hyperinsulinism.

And that puts Elam and Rezolute on track to make a meaningful difference in the lives of others.

“If you can actually make a difference in a child's life, there's nothing like it.”

Robin Robinson is a contributing writer for HealthLeaders. 


After a successful career in life sciences and tech law, Elam turned his focus to metabolic treatments, establishing Rezolute in 2010.

Lead candidate RZ358 is set to launch its global Phase 3 clinical study in mid 2023.

RZ358 aims to treat the most frequent cause of severe, persistent hypoglycemia in newborns, infants, and children.

Rezolute recently initiated Phase 2 proof-of-concept study of RZ402, an oral therapy for DME patients that dramatically changes the form of treatment.

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