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Ad hoc: Biofrontera AG: Clinical program for US approval of Ameluz® approaches completion: Studies confirm excellent efficacy and safety

October 2, 2014 - London

Biofrontera AG /Keyword(s): Misc. matters /Ad hoc: Biofrontera AG: Clinical program for US approval of Ameluz® approaches completion: Studies confirm excellent efficacy and safety . Ad hoc announcement according to § 15 WpHG. Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

  • Clinical program for US approval of Ameluz® completed
  • More than 90% of the patients in phase III study fully cleared of all actinic keratoses after a maximum of two treatments with Ameluz®
  • Only 38% of the patient required second treatment

Leverkusen, 2 October 2014 - Biofrontera AG (AIM/FSE: B8F), the biopharmaceutical company focusing on skin cancer, announces that it has received preliminary results of the ongoing phase III trial, a major component of the clinical program that was executed for the approval of its drug Ameluz® in the USA. The results confirm the company's positive expectations. While the final study reports will become available in the coming weeks, the results will be ready to be discussed with the FDA at the upcoming pre-NDA meeting on October 8th. This represents a major milestone in Biofrontera's global roll-out strategy which includes Ameluz® approval in the US.

In the randomized, double-blind, placebo controlled phase III trial with 87 patients, entire fields on the face or scalp covered with mild to moderate actinic keratoses received photodynamic treatment (PDT) with an entire tube of Ameluz® in combination with Biofrontera's PDT-lamp BF-RhodoLED®. Although field treatment of actinic keratosis with PDT is recommended in the international guidelines no PDT drug is currently registered for such field treatment. In addition to the value the study has for US approval, Biofrontera intends to use the study results to register Ameluz® for actinic keratosis field treatment in Europe.

After a maximum of two PDT treatments with Ameluz®, 90.9% of the patients presented themselves totally clear of any actinic keratosis three months after the last PDT. Only 38.2% of the patients required the second PDT, which strongly reduces the total cost of the treatment. In the placebo group, only 21.9% of the patients were fully cleared, a highly significant difference to the patient group treated with Ameluz® (p<0.0001). The total clearance of individual lesions was, with 94.3% in the Ameluz® group, even higher. No safety concerns became apparent in the trial.

Field treatment of actinic keratosis is particularly relevant for prevention of new actinic keratoses and also for the cosmetic outcome and the well-documented skin rejuvenation effect of PDT. The cosmetic outcome of Ameluz®/BF-RhodoLED® treatment was very good or good in 66.7% of the Ameluz®-treated patients, compared to 34.6% in the placebo group. Unsatisfactory cosmetic properties were reduced to 10.4% in the Ameluz® group, from 42.3% in the placebo group, clearly illustrating the value of the treatment for skin rejuvenation.

In addition to the phase III trial, the FDA had suggested two phase I studies in the clinical program for US approval of Ameluz® and BF-RhodoLED®. The first was a contact sensitization study with 220 healthy volunteers, who were continuously exposed to Ameluz® and placebo for 21 days (intraindividual, placebo-controlled, double-blind design). The volunteers were then challenged with Ameluz® and placebo after a rest period of about two weeks. Long-term exposure of Ameluz® induced irritant reactions during the induction phase in all subjects. However, nobody had to discontinue Ameluz® or placebo drug exposure prior to the regular end of the induction phase. In 6% of the subjects an allergic contact sensitization was observed during the challenge phase. Sensitization was restricted to the application site in all volunteers. Only a low frequency of irritant reactions and no allergic dermatitis was reported for the placebo treated test fields of the volunteers. The allergic skin reactions were classified as delayed type hypersensitivity. Since the design of the sensitization study according to the FDA guidelines is far from the actual clinical situation, the very low number of volunteers developing a contact sensitization confirms the safety of the treatment with Ameluz®. By comparison, in a similar study performed with competing product Metvix 38% of the subjects had to stop the incubation prematurely and 52% of the remaining subjects displayed allergic reactions in the challenge phase (Korshoj et al., 2009, Contact Dermatitis 60: 320).

Furthermore, the FDA had suggested a maximal use pharmacokinetic study which was performed as a non-randomized, open-label, placebo-controlled, fixed-sequence, intra-individual phase I study applying 1 entire 2 gram tube of placebo or Ameluz® to 12 AK patients suffering from at least 10 mild or moderate lesions in the face or forehead. Preliminary results showed no increase in the plasma concentration of protoporphyrin IX (PpIX), but a slight transient increase above baseline in plasma 5-aminolevulinic acid (ALA) levels. The transient increase of ALA plasma concentrations observed in this maximal use study peaked between 3-4 h after drug application. The elevation in the ALA concentration is well below the daily rate of ALA synthesis and not expected to yield any noticeable clinical effect and thus regarded as uncritical for the patient.

Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen
ISIN: DE0006046113
WKN: 604611

Biofrontera AG
Tel.: +49 (0214) 87 63 2 0, Fax.: +49 (0214) 87 63 290

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Source: Biofrontera AG via Globenewswire



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