"Obicure" signed a license agreement for the clinical development and supply of betahistine in delayed release with "Formanti" - the subsidiary of "Grunenthal"
The histelin developed by "Obicure" is based on betahistine dihydrochloride, which activates the histamine system in the brain in a double mechanism similar to "tongs" - both by activating H1 receptors and by blocking H3 receptors - a receptor whose function is to control histamine activity By delaying its production. The drug's safety has been known since the 60s, when it was approved as a treatment for Meniere's disease (vertigo). Since then, approximately 100 million men and women have been treated worldwide (except for the USA, where the FDA removed it from the shelf as early as 1972 due to doubts about its effectiveness in Meniere's disease (although its safety was not questioned).
The "Obicure" company has a series of approved patents and patent applications for the use and formulation of the drug for weight control indications. Recently, the company has been focusing on the clinical development of histelin for combined use with antipsychotic drugs to treat schizophrenia, bipolar disorder and depression - a target market of approximately 15 billion dollars.
Recently, "Obicure" reported success in initial trials (Phase 1b) that it conducted with the indication: according to the results of the study, the administration of a high dose of histelin in combination with the antipsychotic drug Zyprexa significantly and statistically significantly reduces both weight gain and sleepiness - the most problematic side effects of the use Bezipraxa - and caused by the antihistamine activity of the psychiatric drug in the brain. It should be noted that the two side effects also characterize the use of other antipsychotic drugs - Risperdal, Seroquel and Abilify. Also, the safety of the drug at the high dose, both on its own and in combination with Zyprexa, has been proven. Results of a Phase 2 pilot trial that was performed at a lower dose in schizophrenia patients also showed that histaline does not interfere with the beneficial antipsychotic activity of Zyprexa.
The guiding idea underlying the development of histelin by "Obicure" is that the activation of the histamine system by betahistine will prevent the antihistaminic activity of the antipsychotic drugs - thus preventing the side effects associated with it. To this end, high doses and/or formulations, such as those developed by Grunental-Italy, will be required to increase the concentration and duration of the drug's activity. To this end, the company entered into an agreement with Grunenthal - Italy, which developed the drug for delayed release.
"This agreement is a significant step in our efforts to develop histelin for psychiatric indications and to ensure that patients taking antipsychotic drugs will not be exposed to health hazards caused by the severe side effects that accompany them," said Dr. Yaffe Beck, CEO of Obicure. According to her: ""Grunenthal is a first-rate partner and will provide the tablets necessary for our research at the highest quality and level. Also - the delayed release technology significantly improves the chances of success in the trials planned for the approval of the drug as well as a significant strengthening of our intellectual property."
"Obicure's" histelin drug is intended for a medical field in which there is an immediate need to reduce the negative side effects of drugs that, although they are highly effective as a treatment for psychiatric patients, but expose them to other serious diseases.
The market for psychiatric drugs reached more than 15 billion dollars last year and in recent years there has been increasing concern among doctors and regulatory authorities and there is a consensus regarding their side effects. The weight gain (which may reach an average of about 8 kg in children treated with Zyprexa for only 12 weeks), causes extreme obesity and, as a result, diabetes and heart disease. The FDA even placed warnings (Black Box warning) about all the leading antipsychotic drugs. As for the drowsiness caused by these drugs, it prevents many patients from the possibility of working in an orderly manner, continuing their studies and even driving themselves. Because of this, many patients avoid taking their medication. The medicine of "Obicure" aims exactly to counteract these problems and thus its great advantage.
According to the terms of the agreement, the Italian company will provide the drugs for the comparative trials of "Obicure" - both delayed release and normal release, as well as placebo tablets, and depending on the success of the trials, will produce the drug exclusively and in return will receive a license to distribute the drug in Italy.
About Grunenthal:
"Grunenthal" is an international pharmaceutical company that was founded in Germany and specializes in the development of innovative drugs in the field of pain, including delayed administration. The company, founded in 1946, is independent and family-owned and has subsidiaries in 34 countries around the world. and employs about 2,000 people in Germany and another 5,200 around the world. In 2008, the company's sales reached about 864 million euros.
One response
That I understand: "Clinical development" is experiments on humans?