Durect (DRRX)

[realfast95]

follow up: Designated status, was given 7/6/17 to
5-cholesten-3ß, 25-diol 3-sulfate sodium salt (25HC3S)
Treatment of primary sclerosing cholangitis (PSC)
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=586317

From the Q1 earnings transcript, it is mentioned as such:

https://seekingalpha.com/article/4071961-durects-drrx-ceo-jim-brown-q1-2017-results-earnings-call-transcript?page=5

So what are the next steps for our DUR-928 program? For the oral program we are working to initiate a Phase 2 study in primary sclerosing cholangitis later this year. For the injectable program we are working to initiate a Phase 2 study in acute organ injury this year and for the topical comparable program we are developing topical formulations for testing in the Phase 2 psoriasis study early to be -- initiated early in 2018.

I will now review the old program in little more detail. We are actively working towards the Phase 2 trial in primary sclerosing cholangitis or PSC, with orally administer DUR-928. PSC is a chronic liver disease characterized by a progression of progressive cholestasis that is a decrease in bio-flow overtime. With inflammation and fibrosis of the bile ducts. It’s an orphan medical condition for which there is no established medical treatment.

Directors working with PSC, patient efficacy groups to facilitate the study of DUR-928 in this important orphan disease. We anticipate initiating a Phase 2 study of DUR-928 in PSC patients later in the United States later this year. For the injectable program of DUR-928, our third Phase 1b study with DUR-928 which is being conducted in Australia is an open-label single ascending dose safety PK study in patients with impaired kidney function. These are patients who have stage 3 and 4 chronic kidney disease.

Our matched and also matched control subjects with normal kidney function. This study has been conducted in successful cohorts evaluating a low dose and a high dose of IM injected DUR-928. Both cohorts will consist of six kidney function impaired patients and three matched control subjects. Data from the low dose cohort showed the PK parameters between the kidney function impaired patients and those subjects with normal kidney function were comparable.

After a PK safety review of this cohort patients are now being enrolled in the high dose cohort, utilizing a dose four times larger than the low dose cohort and we expect to complete this study shortly. We are currently working closely with expert advisors to design Phase 2 trial in one or two more indications with an injectable formulation of DUR-928 and expect to begin Phase 2 in the United States later this year.

And lastly for our topical program for DUR-928. As previously disclosed, we completed a Phase 1b trial in psoriasis patients utilizing a microplaque assay with intralesional injection of DUR-928. This study demonstrated promising activity, which we believe warrants further investigation and we are currently developing topical formulations of DUR-928, which will be evaluated in a Phase 2 psoriasis trial.

We believe there is a large unmet medical needs for new drugs to treat skin inflammatory diseases such as psoriasis or atopic dermatitis. Since many currently available treatments are either dissatisfactory or are associated with unwanted side effects.

In summary, the results of these studies evaluating the effects of DUR-928 are impressive, even with just a single dose. This molecule is highly conservative across all seven mammalian species we have studied to-date. There are no toxic signals observed in any of our GLP talk studies even when we dosed to extremely high levels. Not surprisingly our healthy volunteers now more than 100 tolerated DUR-928 very well.

Even when plasma concentration in some subject were great than a 1,000 times their endogenous levels. Yet, when DUR-928 is given at low doses in more than 10 different animal disease models, the beneficial effects have been striking.

Similarly the biologic activities we saw after single dose of DUR-928 has shown in our Phase 1b study results have been impressive in both NASH and psoriasis patients. The more data we generate, the more we are convinced that DUR-928 may represent a new class of therapeutics that has the potential to treat a range of important indications.