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Summary

  • BioSpecifics announced positive, statistically significant results from a Phase 2a study involving XIAFLEX for potential treatment of cellulite.
  • Previously I shared that top-line 30-day data from Phase Ib study showed that XIAFLEX is effective, safe and well-tolerated for Cellulite.
  • The positive and statistically significant results from the Phase 2a study confirm my bullish outlook for BioSpecifics.

BioSpecifics Technologies (NASDAQ:BSTC) recently announced positive, statistically significant results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum or CCH (known as XIAFLEX in the in the US and XIAPEX in the EU) for the potential treatment of edematous fibrosclerotic panniculopathy, commonly called cellulite. Three doses of CCH were administered in the study, including a low, medium and high dose, which demonstrated an improvement in the appearance of cellulite, measured by the trial endpoints.

BioSpecifics' strategic partner Auxilium Pharmaceuticals (NASDAQ:AUXL) conducted the trial, the primary endpoint of which was an investigator and a patient score on the Global Aesthetic Improvement Scale ("GAIS"). GAIS is an FDA-recognized scale developed as an assessment of degree of improvement, and adapted by Auxilium for use in the trial. BioSpecifics is entitled to get royalties for XIAFLEX from Auxilium until 2028.

In my original article I said that BioSpecifics is an excellent play on XIAFLEX, in addition to Auxilium. Cellulite is an exclusively female problem and represents a pathological state of fat cells (adipocytes). According to various sources, 80% to 95% of women are suffering from cellulite, and the affected areas are thighs and buttocks, more rarely - back and arms. XIAFLEX has huge potential from cellulite, apart from three other diseases including Dupuytren's Contracture, Peyronie's Disease, and Frozen Shoulder.

Source: Update: BioSpecifics Announces Positive XIAFLEX Data For Cellulite