Emtora Biosciences, a San Antonio, Texas-based clinical-stage biopharmaceutical company announced today it has been awarded a $16.9M non-dilutive grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to advance the clinical and product development of its lead program, eRapaTM, an encapsulated form of rapamycin, for the treatment of Familial Adenomatous Polyposis (FAP).
Emtora was previously granted $3M under a Seed Award from CPRIT in 2019. The Seed Award is being used to complete an ongoing and fully enrolled multicenter Phase 2 trial of eRapaTM in FAP, for which primary endpoint data are expected in January of 2023.
FAP is a rare genetic disease involving mutation of 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 commonly progress to colorectal cancer.
There is currently no approved therapeutic option for the treatment of FAP. The only preventive option that exists is surgical and involves resection of the colon and/or rectum. There remains significant unmet medical need for a safe and effective therapy to treat FAP polyps and impede their progression to colorectal cancer.
Emtora plans to use the CPRIT award to complete a multicenter, randomized, placebo-controlled Phase 3 trial of eRapaTM in patients with FAP. The company believes the successful completion of the planned Phase 3 study will support the approval of eRapaTM under a 505b2 pathway.
The CPRIT award requires a certification of 50% matching funds from external sources. Emtora is currently exploring fundraising and partnering options to secure the required matching funds (initially for Year 1 of the grant) to drive eRapaTM to approval.
The company is separately conducting a grant-funded multicenter, randomized, placebo-controlled Phase 2 trial of eRapaTM in patients with Non-Muscle Invasive Bladder Cancer, with data expected in 2024.