Emtora will use $16.9 million grant to develop treatment for rare genetic disease
Emtora Biosciences, a Texas-based clinical-stage biopharmaceutical company, has received a $16.9 million non-dilutive grant from the Cancer Prevention & Research Institute of Texas (CPRIT).
The funding will be used to advance the clinical and product development of its lead program, eRapa, an encapsulated form of rapamycin, for the treatment of familial adenomatous polyposis (FAP).
Emtora previously received $3 million in a CPRIT Seed Award in 2019. The Seed Award is used to complete an ongoing, fully enrolled, multicenter Phase 2 trial of eRapa in FAP, for which data on the main evaluation criteria are expected in January 2023.
FAP is a rare genetic disorder involving a mutation in the autosomal dominant APC gene.
Patients with FAP are predisposed to the development of hundreds or even thousands of polyps in their gastrointestinal tract. If left untreated, FAP polyps usually progress to colorectal cancer. There are currently no approved therapeutic options for the treatment of FAP.
The only preventive option that exists is surgery and involves resection of the colon and/or rectum. There remains a significant unmet medical need for a safe and effective therapy to treat FAP polyps and prevent their progression to colorectal cancer.
Emtora plans to use the CPRIT award to complete a multicenter, randomized, placebo-controlled Phase 3 trial of eRapa in patients with FAP. The Company believes that successful completion of the planned study will support eRapa’s approval under a 505b2 pathway.
Push for approval
The CPRIT award requires certification of 50% matching funds from external sources. Emtora is currently exploring fundraising and partnership options to secure the required matching funds (initially for Year 1 of the grant) to drive eRapa to approval.
The company is separately conducting a multicenter, randomized, placebo-controlled Phase 2 trial funded by an eRapa grant in patients with non-muscle invasive bladder cancer, with data expected in 2024.