Lyndra Therapeutics, which is moving toward making daily pills a thing of the past, has raised $55 million in Series B financing, funds it will use for Phase II clinical trials, expansion of its Phase I pipeline and manufacturing scale-up.
All original investors from the company’s $23 million Series A round, led by Polaris Partners, resubscribed, and new investors include HOPU Investments, Gilead Sciences, Invus, the Bill & Melinda Gates Foundation and Orient Life.
“The diversity and caliber of our investors, including those who joined this round, speaks to the importance of addressing unmet therapeutic need,” said Amy Schulman, CEO and co-founder of Lyndra Therapeutics. “I am proud of the speed with which the Lyndra team has moved from demonstrating feasibility to the clinic, and now we are well positioned to initiate additional Phase I clinical trials and continue our progress toward Phase II clinical trials.”
“Lyndra’s groundbreaking development in an oral drug delivery system is very exciting and offers real promise to patients and the healthcare system. We are delighted to be Lyndra’s partner,” said Cliff Chau, Partner at HOPU Investments.
Lyndra is moving toward submitting an Investigational New Drug Application (IND) for a long-acting schizophrenia pill in 2019 in anticipation of starting a Phase II clinical trial in 2020. It also plans to bring other drug candidates, including its own therapies and drugs commercialized with partners, through Phase I, II and III clinical trials.
“Lyndra’s long-acting therapies have the potential to address a diversity of disease states,” said Robert Langer, co-founder and Board Member of Lyndra Therapeutics. “The ability to move from daily to weekly administration of an oral drug is groundbreaking. I believe Lyndra’s long-acting oral pill will be truly transformative.”
“Lyndra’s vision is to address unmet need for conditions that affect large patient populations, starting with schizophrenia, and this funding moves the company a step closer to late-stage clinical trials and manufacturing scale-up that will bring this vision to life,” said Catherine B. Reynolds, Chair of the Board of Directors for Lyndra Therapeutics.
The announcement comes on the heels of positive early clinical study results and a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for intellectual property related to Lyndra’s ultra-long-acting oral dosage form. To date the dosage form has been safely administered in 50 subjects during Phase I clinical trials in Australia.