Small start-up firm BioMarck Pharmaceuticals Ltd. is ready to move its lead compound into Phase II testing in chronic obstructive pulmonary disease, thanks to a $4 million private placement.
Founded about four years ago to target respiratory diseases associated with mucus hypersecretion, the company's work - also its name - is based on technology licensed from the University of North Carolina that targets MARCKS (myristoylated alanine-rich C-kinase substrate), a protein required for mucus secretion. BIO-11006, an inhaled drug candidate emerging from that technology, recently completed Phase I testing and is set to start a Phase IIa study in the fourth quarter in COPD.
A disease that affects about 12 million people in U.S., and causes an estimated 120,000 deaths per year, COPD is characterized by limited airflow in the lungs due to excessive mucus secretion and inflammation. Yet there are no drugs on the market that treat COPD by specifically targeting that oversecretion process. BioMarck hopes to be the first.
"What we have is a first-in-kind mechanism to inhibit mucus hypersecretion," said Indu Parikh, co-founder, president and chief scientific officer of BioMarck. He added that, "in light of its dual inhibitory activity," the technology also has potential to block the inflammatory process in COPD as well.
The company's clinical development of BIO-11006 is based on preclinical studies showing that, by blocking MARCKS protein function in human bronchial epithelial cells, researchers could inhibit mucus secretion. In a mouse model using BIO-11006, given intratracheally, mucus oversecretion was inhibited, with the effect lasting for several hours after treatment.
That same mechanism also could prove efficacious against other pulmonary diseases, such as cystic fibrosis and rhinitis, and could lead to other compounds for development. But, for now, BioMarck prefers to "concentrate on one product" rather than diluting its resources among several programs, Parikh told BioWorld Today. Funds from the recent financing, along with grant money from the National Institutes of Health, are expected to get BIO-11006 through the upcoming Phase IIa trial, which BioMarck anticipates completing around the middle of 2008.
Ultimately, the firm said, it plans to seek a partner for late-stage development and commercialization to the large COPD market.
To date, BioMarck has raised nearly $12 million in angel investments and private financing rounds, and has added more than $4 million in Small Business Innovative Research grants from the NIH, including a $1.2 million Phase II award in 2004 and a $3 million Phase III grant received last year.
BioMarck is based in Research Triangle Park, N.C., though the company said much of its work is done by outsourcing and through contract research organizations.
In other financings news:
• NPS Pharmaceuticals Inc., of Parsippany, N.J., said it has raised nearly $200 million in three separate transactions, which will be used to retire its 2008 convertible debt and boost its balance sheet. The company issued $100 million in Series B, Sensipar royalty-backed notes and issued $50 million in convertible notes to funds managed by Visium Asset Management LLC. As previously reported, the company sold its royalty entitlement from European sales of Preotact by Roskilde, Denmark-based Nycomed AS for $50 million up front. NPS could get another $25 million from Nycomed in 2010 upon the achievement of certain milestones. NPS reported a net loss of $14.8 million, or 32 cents per share, for the second quarter of 2007. As of June 30, the company had $91.4 million in cash. Shares of NPS (NASDAQ:NPSP) gained 18 cents Wednesday to close at $4.26.
• Oculus Innovative Sciences Inc., of Petaluma, Calif., is raising $10.1 million in a private placement of 1.3 million shares priced at $8 each. Investors also will receive warrants to purchase up to 417,000 additional shares at an exercise price of $9.50 each. Oculus intends to use most of the net proceeds to fund the ongoing Phase II trial of its Microcyn technology for treating mildly infected diabetic foot ulcers, as well as for activities related to the Phase III trials and to fund ongoing operations. Microcyn is a nonirritating small-molecule oxychlorine compound designed to treat a range of pathogens, including antibiotic-resistant strains of bacteria, viruses, fungi and spores.
• Oragenics Inc., of Alachua, Fla., completed an equity-based financing with a group of investors, including existing shareholders, to raise about $1.2 million. The company issued 4.6 million shares of stock at 25 cents apiece, with the exception of shares purchased by Ronald Evens, Oragenics' newly appointed director, who participated at a price of 44 cents per share. Investors also received an equal number of warrants that will be exercisable at 58 cents each. Oragenics plans to use proceeds to support the clinical development of its technologies and for general corporate purposes. Shares of Oragenics (AMEX:ONI) closed at 46 cents Wednesday, up 2 cents.
• Senesco Technologies Inc., of New Brunswick, N.J., entered agreements for the private placement with YA Global Investments LP of up to $5 million in three-year, secured convertible debentures with an 8 percent coupon, pending approval by the American Stock Exchange. The company intends to close on $1.5 million immediately and $1.5 million upon the filing of a registration statement, with the balance subject to stockholder approval and the company's fulfillment of other covenants and milestones. Proceeds will be used to advance a certain cancer target with the goal of initiating a Phase I trial, as well as for other health and agricultural research and general corporate purposes.