"Promising" results from Ph 1b of 7811 in dyslipidermia. Talk of Ph2 starting this summer. So they have two drugs making progress in the clinic, just under $40M in cash and a burn rate of just over $40M per year. [warrant redemption in Apr gave them about $10M]. With about 120 on the payroll, they have about 50% of their cost in labor. So do they try advancing 7811 though ph 2 and partner the one bringing the most bucks in spring of 2009? Lay off half the work force this summer and gain about 3 quarters of life? Try to pump a little more good news and sell another 10M shares at about $4? Pull rabbit from hat [what rabbit?]
Wondering where the bottom really is so I can go bottom fishing,
graham
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phx.corporate-ir.net;
Metabasis Announces Promising Results from Its Phase 1b Clinical Trial for MB07811, Its Novel Product Candidate for the Treatment of Hyperlipidemia
SAN DIEGO--(BUSINESS WIRE)--June 19, 2008--Metabasis Therapeutics, Inc. (Nasdaq:MBRX) announced today the results of its 14-day, Phase 1b multiple-dose clinical trial in subjects with mild hypercholesterolemia, which showed that MB07811 was safe and well tolerated across the seven doses tested, ranging from 0.25 mg up to 40 mg. There were no serious adverse events, and the frequency of adverse events in MB07811-treated subjects was similar to placebo-treated subjects. No differences in heart rate, heart rhythm or blood pressure were observed between MB07811 and placebo-treated patients. Mild increases in liver enzymes were observed at the higher doses of MB07811 along with dose-related mean shifts in thyroid hormone levels. The clinical trial results also showed dose-related reductions in fasting low-density lipoprotein cholesterol (LDL-C) and fasting triglyceride (TG) levels at day 14. Significant placebo-adjusted LDL-C reductions from baseline were observed at doses of 5 mg and above and ranged from approximately 15 - 41%, while placebo-adjusted TG levels were reduced by more than 30% at doses of 2.5 mg and above.
This completed Phase 1b clinical trial was a randomized, double-blind, placebo-controlled, rising multiple-dose study that enrolled 56 subjects with a mean baseline LDL-C of 126 mg/dL and a mean baseline TG of 118 mg/dL. Subjects received either placebo or MB07811 at an oral dose of 0.25 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 40 mg. MB07811 is a novel, orally administered, beta-subtype-selective thyroid hormone receptor (TR beta) agonist that is designed to target the liver in order to avoid or minimize well known side effects of thyroid hormone receptor (TR) agonists.
TR agonists represent a novel and potentially important approach for reducing LDL-C (known as the "bad" cholesterol) and total cholesterol, liver and serum triglycerides and lipoprotein (a) (Lp(a)). However, use of this approach has been limited by side effects, which include adverse cardiac effects, as well as adverse effects on the thyroid hormone axis, muscle metabolism and bone turnover. Metabasis believes that a liver-targeted TR beta-selective receptor agonist has the potential to improve the therapeutic index of TR agonists by minimizing extra-hepatic activation of thyroid receptors and the associated therapy-limiting side effects.
"The results of this clinical trial provide evidence that MB07811 is capable of significantly lowering both LDL-C and TG levels in patients with mild hypercholesterolemia without affecting heart rate, heart rhythm or blood pressure," commented Howard Foyt, M.D., Ph.D., FACP, vice president, clinical development. "The primary purpose of this Phase 1b clinical trial was to assess the safety and tolerability of MB07811 and consequently we tested doses well above doses expected to lower lipids. The changes observed in both liver enzymes and thyroid hormones at the higher doses, while not unexpected based on this class of drugs' pharmacologic mechanism, will continue to be monitored and evaluated in future clinical trials. Importantly, we believe the overall safety and tolerability results in this clinical trial support continued development of MB07811 and speak to the potential of this drug class for the treatment of hyperlipidemia."
"Although not its primary purpose, we are very encouraged with the clinically significant reductions in both LDL-C and TGs we observed in this early clinical trial," commented Dr. Paul Laikind, president and chief executive officer. "We believe that the potential ability of this new drug class to simultaneously lower LDL-C and TGs as well as other presumed cardiovascular disease risk factors such as Lp(a) may prove useful in reducing the risk of cardiovascular disease in patients with hyperlipidemia. In addition, MB07811 has been shown in preclinical studies to reduce liver fat (hepatic steatosis). Fatty liver is a common condition associated with insulin resistance and an increased risk of cirrhosis and liver failure. These results, combined with the positive results from our recently completed Phase 2a proof-of-concept clinical trial for our diabetes drug candidate, MB07803, have made for a very exciting first half of the year. In addition, our discovery group is making excellent progress toward discovering new ways to treat metabolic disease including moving towards recommendation for development of a novel glucagon antagonist for treating diabetes. Together, this preclinical and clinical progress represents a very exciting future profile for Metabasis. In addition, we are making excellent progress on our business development activities. Success in this area will help us secure the resources we need to optimize the value of our many preclinical and clinical product candidates."
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