REG - Biofrontera AG - Ameluz Phase III Preliminary Results <Origin Href="QuoteRef">B8FGn.DE</Origin>

Biofrontera AGAnnouncement

29/10/2014 07:35

RNS Number : 2546T
Biofrontera AG
02 October 2014
Biofrontera AG
("Biofrontera" or the "Company")
Clinical program for US approval of Ameluz approaches completion: Trials confirm excellent efficacy and safety
 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
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 duringthe 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.
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For further information, please contact:
Biofrontera AG
Prof. Hermann Lbbert, Chief Executive Officer
Thomas Schaffer , Chief Financial Officer
Tel:+ 49 (0) 214 87632 22
finnCap (Nomad and Broker)
Geoff Nash / Christopher Raggett (Corporate Finance)
Tel: +44(0) 20 7220 0500
Steven Norcross(Corporate Broking)
Investor Relations
Seton Services
Toni Vallen
Tel: +44(0) 20 7603 6797
Financial PR
Gable Communications
Tel: +44(0) 20 7193 7463
John Bick
Tel: +44 (0)7872 061007
Notes to Editors:
Biofrontera AG (AIM/FSE: B8F, ISIN DE0006046113) is a biopharmaceutical company specialising in the development and distribution of dermatological drugs and medical cosmetics for the treatment and care of skin diseases. Biofrontera's main product is Ameluz, a prescription drug approved for use in Europe for the treatment of mild to moderate Actinic Keratosis (superficial skin cancer) by photodynamic therapy (light therapy). Biofrontera is the first small German pharmaceutical company to receive a centralized approval for a drug developed in-house. The Company is looking to further develop Ameluz for use in Basal Cell Carcinoma and is currently progressing through regulatory approvals to sell the product in other territories, in particular the largest pharmaceutical market, the USA.
In addition, the Company markets the Belixos cosmetic series with plant extracts, currently available in cream and liquid formulations which offer nurturing and regenerating effects for people suffering from pruritus, dry skin or chronic ailments such as eczema or psoriasis.
Biofrontera group was founded in 1997 by Prof. Dr. Hermann Lbbert, the CEO, and is headquartered in Leverkusen, Germany.
www.biofrontera.com
This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the assumptions expressed or implied in this press release to be faulty. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on the forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments.

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