AUPH: Now that Ph3 for LN is underway (AURORA Trial), where do we go from here...
Aurora Trial update:
-Phase 3 has commenced and off to a strong start having 26 trial sites already enrolling patients, and expected to have upwards of 200 sites total for a full enrollment of around 320 patients.
-This is a fully blinded study, with no interim data. Enrollment is expected to take 12-18 months, and top-line data is expected following the 52wk period of the last patient enrolled.
Any other catalysts in the meantime?
-CEO Dr. Glickman has informed everyone that they plan to announce this fall their plans of seeking additional indications for VoC.
-VoC has been studied in over 2600 patients for various conditions and indications. VoC has performed very well in a few of those trials. For various reasons when AUPH was formed they decided LN was the best opportunity for their first approval.
-Glickman confirmed they will be seeking multiple additional indications, with Dre Eye Sydrome (DES) being one of them. Out of the conditions they've already studied I would anticipate either Transplant or Psoriasis will be another indication they will pursue.
-AUPH has already been approved for a Ph3 transplant study with SPA (Special Protocol Assessment).
-VoC is a more efficient & less toxic Cyclosporine, so anything Cyclosporine has been used for is potentially a target.
-There is always the possibility that they have other autoimmune diseases in mind that they haven't already pursued in the past.
The future is bright, but can AUPH handle all that?:
-Auph has $200m on hand to get them to approval for LN. These other indications will cost a lot and additional funding will be needed. I believe it's very likely we see a partnership in the near future.
-Auph is in a great position for negotiating a partnership, so I expect the terms to be very favorable. If they announce a partnership at the same time as the new indications (which I hope they do), skies the limit!
-Auph has the attention of many types of players (tutes, longs, shorts, traders, options, etc.) so guessing the day-to-day & week-to-week action doesn’t interest me much. I've been long for well over a year and will hold for the endgame while not paying too much attention to the rollercoaster ride along the way.
VoC's History:
-Voclosporin Development History
Voclosporin has been tested in more than 2,600 patients, including studies where it was compared to placebo or active control. The safety
and tolerability profile of the drug therefore is well characterized. Phase 2 or later clinical studies that have been completed include studies
in the following indications:
Psoriasis: To date, two Phase 3 clinical studies in patients with moderate to severe psoriasis have been completed. The primary efficacy
endpoint in both studies was a reduction in Psoriasis Area and Severity Index, which is a common measure of psoriasis disease severity.
The first study treatment with voclosporin resulted in statistically significantly greater success rates than treatment with placebo by the
twelfth week. In a second study comparing voclosporin against cyclosporine, the drug was not shown to be statistically non-inferior to
cyclosporine in terms of efficacy; however, voclosporin proved superior in terms of limiting elevations in hyperlipidemia. Due to the
evolving psoriasis market dynamics and the changing standard of care for the treatment of this disease the Company has decided not to
pursue further Phase 3 development.
Renal Transplantation: A Phase 2b clinical trial in de novo renal transplant recipients was completed. Study ISA05-01, the PROMISE
Study was a six month study with a six month extension comparing voclosporin directly against tacrolimus on a background of MMF and
corticosteroids. Voclosporin was shown to be equivalent in efficacy, but superior to tacrolimus with respect to the incidence of new onset
diabetes after transplantation. In 2010, tacrolimus lost its exclusivity in most world markets and as a result, the competitive pricing
environment for voclosporin for this indication has come into question. Additionally, the more expensive development timelines for this
indication has made it a less attractive business proposition as compared to the LN indication, even when considering the fact that a special protocol assessment has been agreed to by the FDA for this indication.
Uveitis: Multiple studies in various forms of non-infectious uveitis have been completed over the past several years by Lux, a former
licensee of the Company, indicating mixed efficacy. In all but one of the studies, completed by the licensee, an impact on disease activity
was shown in the voclosporin group. However achievement of the primary end-points in multiple studies could not be shown. Uveitis is a
notoriously difficult disease to study due to the heterogeneity of the patient population and the lack of validated clinical end-points.
However in all of the uveitis studies completed, the safety results were consistent and the drug was well tolerated. The Company has now
successfully terminated its licensing agreement with Lux. In conjunction with this termination the Company has retained a portfolio of
additional patents that Lux had been prosecuting that are focused on delivering effective concentrations of voclosporin to various ocular
tissues. The Company will continue to evaluate these patents and make strategic recommendations on how they fit into the ongoing
strategic directives of the Company.
Good luck to all, and please remember this is my opinion only
