Astralis is busy analyzing data from a Phase II trial of Psoraxine after the psoriasis drug missed its primary endpoint, causing the company's shares to drop by nearly 50 percent.
Though Psoraxine was found to be safe and well tolerated, preliminary analysis showed that patients who received the intramuscular injection failed to show a statistically significant improvement in symptoms, as measured by the Psoriasis Area and Severity Index, compared to patients receiving placebo. Patients received six injections over a 12-week treatment period. Considering that the product was efficacious in earlier testing, the results especially were disappointing for Fairfield, N.J.-based Astralis.
"We have to look at what caused the anomalies," said Lindsay Ronan, manager of finance and administration for Astralis. "We can't really explain it at this time."
The company's shares (OTC BB:ASTR) lost 30 cents, or 48.4 percent, to close at 32 cents.
Psoraxine has been in development by Astralis for several years. Versions of the drug were tested in more than 2,700 patients in Venezuelan clinics, and the company reported that 96 percent of those patients showed a positive response to the product. About 1,000 patients experienced between 70 percent and 99 percent psoriasis reduction, and 648 experienced 100 percent reduction. In August, Astralis released results from a Phase I trial of Psoraxine, which, though designed to determine safety, produced data that showed patients in the Psoraxine group showed more improvement than patients receiving placebo.
To discover why the new trial failed, Astralis will be looking at possible causes, such as the differences in the length of the treatment period and the dosing range, Ronan said.
"We'll be taking a look at data, looking at the patients and running different analyses" to try to understand "why we got the data we did," she told BioWorld Today. The company said further details of the Phase II trial will be available after all data analyses are complete.
Psoraxine is a protein-based therapy designed to work by stimulating cells from the patient's immune system to reverse the inflammatory process responsible for psoriasis symptoms. It is the first product developed by Astralis to reach clinical studies. The company also has products in preclinical development for eczema, psoriatic arthritis and leishmaniasis.
Astralis remains optimistic it eventually will bring Psoraxine to market, though it would be a crowded market, with several products already selling and more coming down the industry's pipeline.
The leader, said Sena Lund, analyst with New York-based Cathay Financial LLC, is Thousand Oaks, Calif.-based Amgen Inc.'s Enbrel, which "really kicked off the biologics market" and is followed by Raptiva, from South San Francisco-based Genentech Inc. Next is Amevive, from Cambridge, Mass.-based Biogen Idec Inc.
"Those are the three top biologics on the market that are competing with the traditional steroids and antibiotics," Lund told BioWorld Today.
All three products, along with Malvern, Pa.-based Centocor Inc.'s Remicade, are TNF-inhibitors, designed to block T-cell activity. TNF-inhibitor Humira is in development by Abbott Laboratories, of Abbott Park, Ill., for psoriasis.
In development is ISA247, a cyclosporine analogue being developed by Isotechnika Inc., of Edmonton, Alberta. The company initiated a Phase III trial in December and results are expected late this summer.
Two companies are developing vitamin D analogue products: QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., is expected to begin Phase III trials of QRX-101 this year, and Cytochroma Inc., of Markham, Ontario, is in early clinical development with its product, CTA018.
Other products in development include Birmingham, Ala.-based BioCryst Pharmaceuticals Inc.'s BCX-4208, designed to inhibit the PNP (purine nucleoside phosphorylase) enzyme; Charlotte, N.C.-based Chelsea Therapeutics Inc.'s CH-1504, an antifolate compound expected to begin Phase I this year; and a second-generation antisense drug, ATL-1101, in development by Carlsbad, Calif.-based Isis Pharmaceuticals Inc. and Antisense Therapeutics Ltd., of Melbourne, Australia.
The competition is increasing, but since psoriasis "is a very difficult disease to control," Lund expects the market to grow.
Figures from the National Psoriasis Foundation estimate that between 1 percent and 3 percent of the population might suffer a form of psoriasis, and anywhere from 10 percent to 30 percent of those people also will be diagnosed with psoriatic arthritis. Even competing against Raptiva or Enbrel, there is "a good market" for Astralis, Ronan said.
"Our product is different because it's an immunostimulant, not an immunosuppressor, as those drugs are," she said. "So we believe we still have a market niche and we have a product that we still plan on bringing to the market once we perfect it."