BioBonds: Innovative legislation would help fund clinical trials, including those for LCA

A proposed Congressional Act designed to help researchers launch clinical trials for emerging treatments gives hope for getting more treatments across the finish line for people living with a broad range of medical conditions, including rare retinal diseases, such as Leber congenital amaurosis (LCA). 

The BioBonds legislation establishes loans up to $25 million to a researcher or company as an innovative way to finance early-stage clinical trials. The program would provide $10 billion annually for three years.

Researchers would be required to repay the low-interest, government-backed loans. 

Hope in Focus, along with Foundation Fighting Blindness (FFB) , and more than two dozen other entities, have signed on in support of the legislation.

“Funding for research for all diseases, including rare conditions such as LCA and other rare inherited retinal diseases (IRDs), is always a challenge and was made even more so when COVID hit and so much of biomedicine research was held up,” according to Laura Manfre, President and Co-Founder of Hope in Focus (formerly known as Sofia Sees Hope).

“While we are ever grateful to our funders and grantors, we are excited that the loans provided through this legislation have the capacity to increase momentum and accelerate the development of treatments and cures for blindness and an array of other diseases.”

Biomedical Research Act hopes to bridge chasm between promising research and clinical trials for treatments for LCA and a range of medical conditions

Officially known as the Long-Term Opportunities for Advancing New Studies (LOANS) Biomedical Research Act – H.R. 3437 – the proposed legislation creates a unique way of mobilizing capital of long-term investors to give loans to companies developing treatments and cures for a wide range of disease and disability.

U.S. Representatives Bobby L. Rush (D-IL) and Brian Fitzpatrick (R-PA) introduced the LOANS for Biomedical Research Act to help bridge the financial “valley of death” that separates promising research from clinical trials necessary to delivering federally approved treatments and cures.

Most pharmaceutical and biotechnology companies do not fund early-stage clinical research. By funding early-stage human studies, H.R. 3437 can help move research to the point where it could attract investment from industry for late-stage clinical trials, which often cost hundreds of millions of dollars.

Hope in Focus and FFB, along with other organizations, sent a letter to the representatives in support of this initiative to leverage billions of dollars in private-sector investment to advance early-stage clinical biomedical research.

The letter in part states: “Without H.R. 3437, vital medical research in blindness, cancer, Alzheimer’s, pediatric rare diseases, conditions disproportionately affecting minority communities, and other diseases will take many more years to complete, no matter how promising the progress just a year ago…

“H.R. 3437 would unleash billions of long-term capital for medical cures at little cost to taxpayers – we can think of few national objectives that matter as much as preventing disease, treating disability, and reducing pain and suffering.”

Retinitis Pigmentosa patient and her husband played key role in developing the legislation

FFB plays a key role as a partner in outreach and awareness. Foundation Board Director Karen Petrou and her late husband, Basil, were visionaries for the legislation.

FFB CEO Ben Yerxa, PhD, applauded the introduction of the Act. 

As head of the world’s leading organization committed to find treatments and cures for blinding retinal diseases, Yerxa said, “As the remarkable speed of the COVID-19 vaccines development and approval processes have demonstrated, financial capacity – not scientific knowledge – is our biggest hurdle to advancing medical research and delivering the life-saving treatments and cures millions of Americans so desperately await.

“From blindness to cancer to juvenile diabetes, the private sector dollars that this bill will infuse into biomedical research will jumpstart clinical trials stalled by the pandemic,” he said. “These trials are designed to convert basic science into treatments and cures for these diseases and so many more, which is why it’s supported by a growing number of patient advocacy organizations.”

Doctors diagnosed Karen Petrou in her teens with retinitis pigmentosa (RP) and she went blind in her 40s. 

A New York Times article describes Petrou’s challenges over four years in developing a new funding model for curing blindness. 

Also, Petrou authored an in-depth paper describing the funding model – Generating Billions in Private-Sector Investment Speeding Treatment and Cure. 

Please see the Biobonds website for more information about the legislation, including signing on as a supporter, seeing the current sponsor list, reading the legislation, and getting assistance with contacting your U.S. House Representative.