Financings Roundup: Third Tranche Adds $23M to PhaseBio's Series B

By Catherine Shaffer
Staff Writer

A third tranche of $23 million brings PhaseBio Pharmaceuticals Inc.'s Series B financing total to $48.4 million. The disbursement was triggered by completion of a Phase I/IIa trial of Glymera in Type II diabetes.

The Malvern, Pa.-based company previously raised $25 million in a financing led by New Enterprise Associates, with Astellas Venture Management (previously OSI Investment Holdings), Johnson & Johnson Development Corp., Hatteras Venture Partners and Fletcher Spaght Ventures participating. (See BioWorld Today, Dec. 3, 2010.)

The funding will support clinical trials of Glymera, as well as studies for Vasomera in cardiac indications and Insumera in Type II diabetes.

"With additional financing from the B round combined with partnering revenues we're planning on with Vasomera, we're looking to advance our diabetes franchise to a high value," CEO Chris Prior told BioWorld Today.

Glymera is a recombinant glucagon-like peptide-1 (GLP-1) analogue for Type II diabetes, similar to marketed GLP-1 agonists like Byetta (exenatide, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.), Victoza (liraglutide, Novo Nordisk A/S) and Bydureon (exenatide LAR, Amylin/Lilly and Alkermes Inc.).

PhaseBio hopes to differentiate Glymera through its long half-life and very slow absorption profile, which make once-weekly dosing possible. "We have the best-in-class long-acting weekly GLP-1 analogue," Prior said. "That keeps the GLP-1 analogue in the body, providing full 24/7 glycemic control, 24 hours a day, seven days a week."

In November 2011, PhaseBio reported that Glymera showed statistically significant reductions in fasting glucose glycemic load following meal tolerance testing and in average daily glucose measured through continuous glucose monitoring following four weeks of dosing in its Phase I/IIa trial.

The study was designed to evaluate its safety, tolerability and pharmacokinetic profile and to evaluate pharmacodynamic effects by measuring fasting glucose, metabolic response to a liquid meal challenge and change in average daily glucose through continuous glucose monitoring before and after dosing.

PhaseBio developed Glymera using its elastin-like biopolymer (ELP) platform technology. Rather than encapsulating a GLP-1 peptide like many of its competitors, PhaseBio makes Glymera by fusing the DNA sequence for the peptide to a DNA sequence for an elastin-like biopolymer. The resulting product has enhanced pharmacology and manufacturing properties.

Prior said slowing down the rate that the product enters circulation allows the body to adjust. The product also can be administered in a very small volume through a narrow gauge needle, which, combined with once-weekly dosing, makes it "very, very convenient," according to Prior.

"Given the fact that diabetes is pandemic and more convenient forms of GLP-1 given on a weekly basis can treat the disease at the earliest stages of disease intervention, the markets are huge, and there is room for multiple players," Prior explained.

PhaseBio's investors opted to support Phase IIb studies of Glymera through a third Series B tranche in order to make the most of that market opportunity.

The Phase IIb trial will be longer term, and will set Glymera against a comparator such as Victoza. "We're considering Victoza as the gold standard for A1c lowering," Prior said. "Victoza gives 24-hour, around-the-clock glycemic control. Our version will be 24/7 glycemic control."

The trial will compare the two drugs in a large group of subjects. PhaseBio currently is working on the design and will issue a release detailing the number of patients and other variables when it is finalized. The trial is expected to be completed in 2013.

The financing also will support studies of other PhaseBio pipeline products. Prior called PhaseBio's Insumera, a fully mature insulin molecule (including B and A chains) genetically fused to PhaseBio's ELP polymer, "very complimentary" to Glymera. "It has the same pharmacokinetic properties as Glymera," he said. PhaseBio plans to take Insumera into Phase I/IIa trials.

Vasomera, as well, will advance under the third Series B tranche. Vasomera is a fusion of an analogue of Vasoactive Intestinal Peptide (VIP) with ELP biopolymer in development for hypertension. PhaseBio will move forward into Phase I and Phase II trials of Vasomera in hypertension and also in acute and chronic heart failure.

PhaseBio began dosing its first subjects in a Phase I trial of Vasomera in hypertension in February. The double-blind, placebo-controlled trial will have safety, tolerability and pharmacokinetic and pharmacodynamic profiling of single-ascending doses as a primary objective. It is expected to be complete by the end of the year.

PhaseBio is looking for a partner to help advance Vasomera.

In other financings news:

• Ceptaris Therapeutics Inc., of Malvern, Pa., raised $10 million through a Series D-1 private placement of preferred stock. The financing included prior investors Vivo Ventures, Palo Alto Investors, Burrill & Co., Aperture Venture Partners, Osage and BioAdvance, plus new investor Third Point LLC. Prior to the financing, Ceptaris received a complete response letter from the FDA regarding its new drug application for mechlorethamine gel for the treatment of early stage mycosis fungoides, a type of cutaneous T-Cell lymphoma. The financing will be used for operational expenses, including activities related to addressing the FDA's requests.