Shares Of Inotek Are Up 52% After Announcing End Of Phase 2 Meeting With FDA

Shares of Inotek (ITEK) are up 52% after the company announced an end of phase 2 meeting with the FDA for its drug candidate known as Trabodenoson. Trabodenoson is used to treat patients with Glaucoma -- a disease that causes blindness but can be avoided with early treatment. This drug works in glaucoma patients by restoring the eye's natural pressure control mechanism. 

The end of phase 2 meeting went well for the company, which has now, with the guidance of the FDA, designed a pivotal phase 3 trial that will be used for an NDA submission of Trabodenoson. The phase 3 trial will commence sometime in Q4 of 2015 and there will be early clinical results sometime in 2016. 

Previous phase 2 studies showed the clinical efficacy that could be achieved with Trabodenoson. The drug was given to patients in 200 mg and 500 mg doses and both saw an improvement in efficacy. At 14 days both the 200 mg and 500 mg saw a reduction of intraocular pressure in glaucoma patients. Those patients on the 500 mg dose continue to see an improvement in intraocular pressure after 28 days of treatment. 

Now Inotek states that the FDA will allow  the company to investigate more than one dose given to each patient. This could improve upon the efficacy profile of Trabodenoson even more. This is because the drug was able to achieve this type of efficacy with no serious adverse events reported from the patients in the trial on the previous doses. 

The phase 2 trials have already shown Trabodenoson to be superior to placebo, and the phase 3 trial design as requested by the FDA will once again compare Inotek's drug to a placebo compound. 

Disclosure: None.

How did you like this article? Let us know so we can better customize your reading experience.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.