Intarcia Gains US$200mn To Complete Phase III Trials Of Implantable Diabetes Treatment
Intarcia Therapeutics has completed a private round of equity financing for US$200mn. The financing adds to a US$210mn round of equity and debt financing secured by the company in November 2012. RA Capital led the round as a new investor and was joined by a mix of new investors Farallon Capital Management, Foresite Capital, Franklin Templeton, Fred Alger Management, New Leaf Venture Partners, Quilvest, and three additional large institutional investors that participated in the previous round.
Intarcia's lead product candidate is ITCA 650 (continuous subcutaneous delivery of exenatide), a novel once-yearly glucagon-like peptide-1 (GLP-1) for the treatment of Type II diabetes, which is currently being investigated in a global Phase III clinical trial programme called FREEDOM. ITCA 650 employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subdermally to provide continuous and consistent drug therapy; and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.
The first interim results from FREEDOM were released by the company in January and showed a 3.2% mean reduction of HbA1c after six months in high unmet need subjects that were failing on diet and exercise and/or standard oral diabetes therapies, and who had a poorly controlled starting baseline HbA1c level of 10.9%. Due to the improvements observed in the interim results, Intarcia immediately decided to extend the study for patients beyond the original nine-month design. This will allow the use of additional six- and 12-month mini-pumps to further evaluate safety and some of the most important potential benefits of the therapy related to the built-in compliance and persistency (with either once or twice yearly dosing).
Execution of the global FREEDOM trial programme for ITCA 650 is fully on track with more than 2,300 patients enrolled out of the 4,000 total patient enrolments planned. Results from the first pivotal clinical trial (FREEDOM 1, which began enrolment in March) will be available at the end of September. Results from a High Base Line (HBL) trial are also expected at the same time. A head-to-head trial versus sitagliptin and a cardiovascular outcomes trial are also expected to complete enrolment in Q214 and the end of the year, with final results needed to support global regulatory filings by early 2016.
If approved, ITCA 650 would be the first and only once-yearly, injection-free GLP-1 therapy for the treatment of Type II diabetes. Intarcia oversees FREEDOM programme with its strategic development partner Quintiles.