San Juan Capistrano-based startup Allegro Ophthalmic LLC is aiming to take on a major cause of blindness and has an enriched war chest to do it with.
It scored a $20 million investment in January from South Korea-based Hanmi Pharmaceutical Co. through a licensing agreement covering its ALG-1001 Luminate compound.
Hanmi, whose annual sales equal about $665 million, is also gaining the rights to Luminate in South Korea and China and must pay Allegro upfront license fees, sales milestone payments, and running royalties as a result of net sales.
Allegro followed up the investment this month with a $2 million grant from the Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 diabetes program. The second grant from the Helmsley trust to Allegro will support a new second-phase study of Luminate in patients who suffer from diabetic macular edema, an eye disease that leads to blindness.
The company is developing drugs to treat diabetic macular edema and wet age-related macular degeneration, both major causes of blindness.
“We are working on bringing a novel drug to market,” said Marc Kirshbaum, Allegro’s chief operating officer.
Diabetic macular edema is usually treated by drugs known as anti-VEGF agents, which target neurological signaling that creates new blood vessels in the eye.
Lucentis, which is made by South San Francisco-based Genentech, a unit of Roche AG in Switzerland, and Eylea, made by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc., are the approved drugs for treating the disease.
The market size is estimated at about $5.5 billion, and Allegro said there’s potential for Luminate down the road.
“Anti-VEGF agents are effective in about 40% of patients,” Kirshbaum said.
About 21 million people around the world suffer from diabetic macular edema, according to the National Eye Institute.
Allegro’s Luminate works differently, in that it interferes with the construction and proliferation of new blood vessels that can cause blindness. Allegro says on its website that clinical studies showed the drug candidate “effectively regresses and inhibits new blood vessel formation, as well as reduces vascular leakage to maintain and restore vision.”
Luminate is delivered to a patient’s eye through injection.
Tests have shown so far that it needs to be injected only every three to four months compared to the every four weeks required for Lucentis and the every six to eight weeks for Eylea, according to Kirshbaum.
He said Luminate is still several years away from coming to market and that it could be ready for commercialization in the 2018-19 time frame. He added that there are several more clinical trials in the works for various other eye ailments.
Workers, Funding
Allegro is prerevenue and has five workers. Kirshbaum said the company will hire more employees with the funding but didn’t give a specific number.
The company is “well-capitalized for our current plans,” he said.
He later added that when the time comes, Allegro will look for additional funding that could come from either strategic partners, such as another eye-drug company, or through a traditional investment firm.
Allegro was established in 2010.
“A lot of our team is in South County,” Kirshbaum said, mentioning Irvine-based Allergan Inc., which grew out of eye drugs, as a root company for Allegro’s current talent.
Allergan Alums
Allegro Chief Executive and cofounder Hampar Karageozian served as head of global research and development at Allergan, and cofounder John Park spent 16 years as a principal research scientist in ophthalmic and optical care product development at Allergan.
“[Karageozian] was two predecessors to [Dr.] Scott [Whitcup],” Kirshbaum said, referring to Allergan’s current head of research and development. Whitcup is scheduled to leave Allergan after its buyout by Ireland-based Actavis PLC is completed this year.
Kirshbaum’s background includes serving as president of Private Access Inc., an Irvine-based healthcare information technology company that helps link drug and device makers with clinical trial subjects.
