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Drugs in Development

Nov 16, 2004

We often hear of new drugs, delivery methods and technologies for our patients. Unfortunately to often what seems like it will be approved next week can be years away if ever. I have done a wide search on some of the most talked about and publicized projects and have prepared an update for you.

Drugs in Development

Dave Joffe, Editor in Chief

We often hear of new drugs, delivery methods and technologies for our patients. Unfortunately to often what seems like it will be approved next week can be years away if ever. I have done a wide search on some of the most talked about and publicized projects and have prepared an update for you.

Sanofi-Aventis has released more positive data for Acomplia.

The latest set of trial data concerning the use of Acomplia (rimonabant) to reduce cardiovascular risk caused by obesity has shown that the Sanofi-Aventis [SNY] drug could be used over an extended period to maintain weight loss. Despite the data showing considerable promise over the efficacy of the drug, there was a noticeable rate of withdrawal due to depression during the trial. The company currently expects to file an application for FDA approval during the second quarter of 2005, with a view to a mid-2006 launch in the US.

Novartis has presented the results of a trial with a new class of antidiabetic agents.

The 12-month phase II study compared the addition of placebo versus once daily LAF-237 to patients’ regular dose of metformin. Results showed that the increase in HbA1c (a measure of average glucose levels) each month was less in patients treated with LAF-237 than those on placebo and that by 12 months the overall difference in HbA1c was 1.1%.

If phase III results, which are expected in Q3 2005, mirror the results to date, LAF-237 could become a very useful new tool to diabetologists in 2006. See how LAF-237 works by clicking here.

Race for fat-busting drugs is building up speed. Datamonitor has identified 22 key compounds currently under development. Of these compounds, only two are in late-stage development, Acomplia, expected to be launched in 2006 and Axokine, expected to be launched by 2008. The most common type of therapies in the pipeline are beta-3 adrenergic agonists. Beta-3 adrenergic agonists are under investigation as a strategy for treating obesity by stimulating metabolism and peripheral burning of fat.

Generex Biotechnology Corporation has released positive results from clinical studies of its insulin spray, Oralin and demonstrated that the buccal spray formulation has a faster onset and a shorter duration of action than regular insulin in trials with healthy volunteers and patients with type I diabetes. The results from these studies show that Oralin is mainly absorbed and effective in the first two hours after administration and therefore is well suited for the management of postprandial glucose excursions.

Eli Lilly is to offer further support for Alkermes’ developmental inhaled insulin product is based on the AIR pulmonary drug delivery system came as a result of a successful Phase II study. According to Alkermes, significant progress has also been made towards the commercial production of the insulin powder and the inhaling system.

Canadian biopharmaceutical firm Innodia Inc has begun a phase I human clinical trial to evaluate the safety of its lead compound, oral antidiabetic drug ID 1101, which has a unique dual antidiabetic mode of activity as it increases insulin secretion by the pancreas and decreases peripheral insulin resistance observed in type-2 diabetes. These activities are dependant on abnormally high blood glucose concentration. ID 1101 is inactive at normal blood sugar concentrations, a characteristic that reduces the risk of hypoglycemia associated with the use of other antidiabetic agents.

Drug discovery firm Syrrx Inc has determined the atomic structure of a key enzyme currently being investigated in clinical trials as a target for the potential treatment of type-2 diabetes.

Studies to date indicate that the enzyme, human 11 (beta)-hydroxysteroid dehydrogenase type-1 (HSD-1), helps regulate levels of cortisol, a steroid hormone that plays an important role in controlling blood pressure and cardiovascular function as well as in regulating the body’s use of proteins, carbohydrates, and fats. As such HSD-1 has been implicated in the development of obesity and type 2 diabetes. By pursuing inhibitors of HSD-1, Syrrx seeks to augment its growing portfolio of efforts directed at treating type-2 diabetes, obesity, high cholesterol and other metabolic syndromes.

GlucoSpray, a proprietary oral glucose spray formulation to be delivered by way of Generex’ proprietary RapidMist device.

Generex’s preliminary R&D efforts have demonstrated that glucose in the GlucoSpray formulation can be delivered into the body very rapidly through the buccal mucosa in the mouth using RapidMist device, with glucose appearing in the blood within five minutes. As a result, precious minutes of relief should be provided to the brain thereby preventing some comas and ameliorating symptoms earlier.

Transition Therapeutics gets go ahead for clinical trial in humans. Researchers were able to show that a short course of GLP1-INT treatment given to diabetic NOD mice restores normoglycemia and has a prolonged effect on blood glucose levels for a period of at least five weeks post treatment.
GLP1-INT treatment is capable of increasing pancreatic insulin and beta cell mass to levels that approach normal levels in non-diabetic animals, which holds promise for the treatment of insulin dependent diabetics," said Dr Tony Cruz, chairman and CEO of Transition. The clinical trial will evaluate the efficacy, safety, and tolerability of a 28-day course of daily E1-INT treatments with a six-month follow-up, and will be conducted in clinical centers in the US. The technology is licensed to Novo Nordisk A/S.

Peptimmune, Inc. has reported that the first participant has been administered GT389-255, a novel conjugate of a pancreatic lipase inhibitor and a fat binding hydrogel polymer. It acts within the gastro-intestinal tract to prevent fat digestion and is thought to have fewer side-effects than current obesity therapies

GlaxoSmithKline has acquired exclusive worldwide rights to develop and commercialize Albugon.

Human Genome Sciences has announced that GlaxoSmithKline has acquired exclusive worldwide rights to develop and commercialize Albugon. Albugon was created using Human Genome Sciences’ proprietary albumin fusion technology, and resulted from the genetic fusion of human albumin and GLP-1, a peptide hormone. They hope to overcome theprimary obstacle to the use of GLP-1, extremely short half-life in the body. Studies have shown that Albugon retains the anti-diabetic and other beneficial activities of GLP-1, but with a substantially prolonged half-life.

Novo Nordisk has decided to terminate further clinical development of its partial peroxisome proliferator activated receptor (PPAR) gamma agonist balaglitazone (DRF 2593), an oral treatment for type-2 diabetes as the pre-clinical results did not suggest a sufficient competitive advantage for balaglitazone compared to similar, marketed products.

Plexxikon and Wyeth Pharmaceuticals have formed a multi-product collaboration to develop drugs for the treatment of diabetes and metabolic disorders.

The collaboration focuses on, PLX204, as well as several other novel small molecule drugs targeting the peroxisome rroliferator-activated receptor (PPAR) family of nuclear receptors. Plexxikon’s PPAR modulators represent an entirely novel chemical class of orally active compounds that could be used to treat a variety of metabolic conditions, including diabetes, insulin resistance, dyslipidemia and obesity. "PLX204 has the potential to address the regulation of cholesterol and glucose levels along with an improved safety profile, all in one medicine." The company has recently completed a single dose non-investigational new drug (IND) study in humans to profile the pharmokinetic properties of PLX204, in preparation for a planned IND filing

Roche is to license a novel anti-dyslipidemic drug from Japan Tobacco.

JTT-705 is a cholesteryl ester transfer protein (CETP) inhibitor for the treatment of dyslipidemia. The compound, which is currently undergoing Phase II clinical trials has shown evidence that it can modify lipid profiles by increasing the levels of high-density lipoprotein (HDL) cholesterol in the blood.

Specialty drug delivery and manufacturing firm Bentley Pharmaceuticals has obtained positive safety and efficacy results for its inhaled diabetes medication in an early trial.

Bentley’s intranasal insulin formulation effectively delivered insulin from 12.5 to 43.75 international units from a nasal device with a peak serum concentration attained at 20 minutes. Plasma glucose and serum C-peptide decreased in a dose-response related manner in response to plasma insulin increases and the intranasal formulation demonstrated a rapid onset of action and appropriate duration of action for potential use in controlling post-prandial hyperglycemia

Drug delivery firm Nastech and leading drugmaker Merck have entered into a global alliance to develop and commercialize Nastech’s phase I nasal spray for the treatment of obesity. The investigational peptide YY 3-36 nasal spray (PYY)."is groundbreaking research in obesity treatment according to Dr Barbara Corkey, president of the North American Association for the Study of Obesity.

Xenon Pharmaceuticals and Novartis AG will research, develop and commercialize compounds from Stearoyl-CoA Desaturase-1(SCD1), a key regulatory enzyme in fatty acid metabolism, and a novel target for the treatment of obesity and its resulting metabolic consequences, including the metabolic syndrome. They will develop small molecule inhibitors of SCD1 and they have advanced preclinical development. This collaboration is being forged to pursue rapid validation of SCD1 as a relevant therapeutic target in patients using SCD1 inhibitor compounds. nducing weight loss by increasing metabolic rate through lipid oxidation is a novel mechanism of action for treating obesity.