November 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Danbury, Conn.-based Biodel Inc. announced yesterday that it was launching a Phase IIa clinical trial to study BIOD-531-based regimens compared to basal-bolum insulin treatments for diabetes.
The study, 3-157, will evaluate how well the treatments control blood glucose levels using BIOD-531, the company’s biphasic insulin formulation. It will also determine the clinical efficacy of co-treatment with Victoza, a leading GLP-1 analog. Victoza is marketed by Novo Nordisk .
On Oct. 12, the company announced that the U.S. Food and Drug Administration (FDA) had removed a partial clinical hold for the company’s Phase IIb study 3-250 of BIOD-531 compared to Humalog Mix 75/25. Humalog is marketed by Eli Lilly & Co.
The new study, will attempt to determine that two or three doses of BIOD-531 alone can control blood sugar equivalent to an intensive insulin treatment where two different insulins are injected four times a day. Preclinical studies have shown that BIOD-531 can be co-formulated with the active ingredient in Victoza, liraglutide, in a stable fashion.
“The unique ultra-rapid-acting pharmacokinetic profile of BIOD-531, which is faster than marketed prandial insulins such as Humalog while providing basal coverage in a single injection, may allow us to effectively compete in the large basal-bolus insulin market by reducing the injection burden and achieving glucose control at least as effective as that with separate basal and prandial insulins in patients with type 2 diabetes,” said Errol De Souza, president and chief executive officer of Bioden in a statement. “Furthermore, the potential combination of BIOD-531 with a GLP-1 analog such as liraglutide could further expand the emerging basal insulin/GLP-1 combination market by providing additional superior prandial coverage. We look forward to reporting the topline data from Study 3-157 towards the end of the first calendar quarter of 2016.”
At the same time, Biodel announced that it will lay off 10 employees, about 30 percent of the company’s staff. The goal is to cut infrastructure costs and improve research and quality assurance and quality control activities. The job cuts will cut annual expenses by about $2 million.
“We believe that these personnel changes,” said Gary Gemignani, chief financial officer of Bioden in a statement, “will more closely align our ongoing efforts towards supporting our later-stage clinical programs, while extending our cash runway.”
On Aug. 13, the company released its third-quarter financial results. The company reported a net loss of $6.5 million for the quarter and a $15.5 million net loss for the nine-month period that ended June 30, 2015.
“This has been a strong quarter for Biodel financially, with the completion of a $34.5 million public offering and an ending cash balance of approximately $44 million,” said De Souza in a statement. “We are pleased with the guidance received from the FDA on requirements for NDA filing for the GEM products and are working diligently to move to resolve recent developments impacting the timelines for the GEM device and to reopen BIOD-531 enrollment as soon as possible.”
Biodel has been on a steady decline since launching its IPO. Shares are currently trading for $0.37 per share. The company announced its public offering on April 15, 2015, offering 32,608,696 shares of common stock at a price of $0.92 per share.
