Plex Pharmaceuticals has been awarded two Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH) National Eye Institute: a $1.3 million Phase II grant (R44EY027236) and a $300,000 Phase I grant (R43EY031609). Under the Phase II grant, Plex intends to advance its lead anti-cataract drug candidate, CAP4196 through preclinical and IND enabling studies to gain clearance from the FDA to initiate its first-in-human clinical trials for the non-surgical treatment of cataracts. Plex also intends to develop its anti-cataract drug candidate, CAP4349 as an effective topical eye drop formulation to enhance its characteristics to effectively cross the cornea and accumulate in the eye lens in concentrations that can result in beneficial clinical outcomes under the Phase I grant.

CAP4196 and CAP4349 are topical eye drop formulations that act as modulators of the eye lens protein, alpha-A-crystallin (AAC). AAC is a major component of the eye lens that helps maintain its transparency. Loss of AAC function leads to the aggregation of damaged and/or aged proteins in the eye lens, which results in the formation of cataracts.

"The successful discovery of these drug candidates, CAP4196 and CAP4349, for the non-surgical treatment of cataracts and the receipt of these grants from the NIH further validates Plex's expertise in the development of treatments targeting diseases associated with protein misfolding and aggregation using its platform technology, which is focused on the discovery of barrier-crossing (CNS and ocular) drug-like compounds," said Dr. G. Sridhar Prasad, Principal Investigator on the Phase II grant and Chief Scientific Officer at Plex.

"The receipt of the Phase I grant from the NIH to optimize CAP4349 as a promising topical anti-cataract eye drop formulation will significantly bolster Plex's pipeline of anti-cataract agents and help to advance this candidate towards in vivo proof of concept efficacy and safety studies," said Dr. Santosh C. Sinha, Principal Investigator on the Phase I grant and Director of Medicinal Chemistry at Plex.

"I am proud to be part of Plex's journey in the development of CAP4196 and CAP4349 to treat cataracts which afflicts more than 35 million patients worldwide. The current standard of care involves surgical intervention that can cause potential side effects such as infections, bleeding, and secondary cataracts in more than 15% of cataracts procedures. If successful, CAP4196 and CAP4349 will be the only topical drugs capable of reversing cataracts without surgical intervention," said Mr. Hoji Alimi, Chief Executive Officer. "Accomplishments by the Plex scientific team will be a major contribution to the world of medicine and may ultimately help alleviate the financial and medical burdens currently felt by the millions afflicted with cataracts globally."