Proceeds to be Used to Complete the Phase 3 (Pivotal) Trial of Octreolin™ in Patients with Acromegaly and to Initiate a Clinical Program in a Second Product
NEW YORK and JERUSALEM, July 23, 2012 /PRNewswire/ -- Chiasma (pronounced key-azma), Inc., a privately held biopharma company, announced that it closed a $38.5 million equity financing co-led by new investor Abingworth and current investor MPM Capital that also included investments from existing shareholders 7 Med Health Ventures, ARCH Venture Partners, F3 Ventures and Fredric Price, Chiasma's Chairman & CEO.
The new investment (the "D" round) is expected to provide funding for the completion of the Phase 3 pivotal program in acromegaly patients for Octreolin (pronounced Ock-tree-o-lin), the Company's proprietary investigational oral form of the peptide octreotide, which is planned to be completed in the second quarter of 2013. It is also intended to finance a clinical study for the Company's second product, a small molecule to be investigated as a possible treatment for a complication of chronic kidney disease (CKD).
Vincent Miles, PhD, Venture Partner at Abingworth and a newly-appointed member of the Board of Directors of Chiasma said, "During the last year, Chiasma has made considerable progress as evidenced by the initiation of the Phase 3 clinical trial of Octreolin for acromegaly, the preparation for a second indication --- neuroendocrine tumors --- for Octreolin and the completion of the necessary preclinical studies for its next drug candidate, which is expected to enter the clinic in the current quarter for a complication of CKD."
Roni Mamluk, PhD, Chiasma's Chief Operating Officer added, "If the results of the Octreolin Phase 3 program for acromegaly are positive, the Company intends to submit a New Drug Application (NDA) using the 505(b)(2) NDA regulatory pathway in the U.S. and its European Medicines Agency (EMA) equivalent, the Hybrid Application, in Europe in 2013."
Additional Information About Octreolin
The Food and Drug Administration (FDA) has granted orphan drug designation for Octreolin for acromegaly. If an NDA is approved, Octreolin would qualify as an Orphan Drug and would benefit from seven years of market exclusivity, potential tax credits, and a waiver of the prescription drug user fee for the marketing application. The Company expects to submit an application for Octreolin for acromegaly for Orphan Medicinal Product Designation to the EMA in 2013.
The pool of acromegaly patients eligible for Octreolin treatment is estimated to be approximately 20,000 in the U.S. and Europe combined, with an additional 10,000 patients in the rest of the world.
Chiasma is developing oral drugs that previously were only available by injection, thereby providing patients with pain-free medications that are self-administered. The Company's lead candidate is an oral form of the peptide octreotide, initially being developed for patients with acromegaly that is in a Phase 3 (pivotal) trial with results expected in the second quarter of 2013. The Company is also developing an oral small molecule intended to replace a drug that is currently available by intravenous injection to treat a complication of chronic kidney disease; it is planned to enter the clinic in the third quarter of 2012. Chiasma is evaluating additional proteins, peptides and small molecules that can be applied to its proprietary Transient Permeability Enhancer (TPE) technology to enable oral delivery of drugs that previously were available by injection only.
Chiasma is a Delaware corporation with a 100% owned Israeli subsidiary. It is backed by Abingworth, MPM Capital, 7 Med Health Ventures, ARCH Venture Partners, and F2 and F3 Ventures.
Additional information can be found at: www.ChiasmaPharma.com.
This press release contains forward-looking statements about the business, goals and prospects of Chiasma, Inc., including, without limitation, statements about the development of drugs in the Transient permeability Enhancer (TPE) system. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Chiasma is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Chiasma, Inc.