12 Month Analysis of Juvista Clinical Trials 0050 & 0036
17th April 2008
Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the reduction of scarring, today announces positive results of the planned 12 month follow-up analysis of two Juvista (human recombinant TGFβ3) Phase 2 clinical trials: RN1001-0050 and RN1001-0036.
7 month data for studies RN1001-0050 and RN1001-0036 were reported in September and December 2007 respectively. The studies were randomised, double-blind, placebo controlled Phase 2 studies designed to investigate the efficacy of varying doses of Juvista on scar improvement in a total of 117 male and female subjects.
0050 and 0036 Highlights at 12 Months
• Analysis of 12 month data supports previously stated efficacious dosage window of 50-500ng/100uL/linear cm, as assessed by lay and clinical panels
• Consistent with previous findings, the greatest magnitude of scar improvement effect was seen in 500ng/100uL/linear cm dosed twice, 24 hours apart, as assessed by lay and clinical panels
Both trials were single-centre, randomised, double-blind, placebo controlled Phase 2 studies designed to investigate the impact of four doses of Juvista (5, 50, 200 and 500ng/100uL/linear cm) in three dosing regimes:
- given once at the time of surgery (trial 0050); - given twice, once before and once after surgery, approximately one hour apart (trial 0036); - given twice, once at the time of surgery and once 24 hours later (trial 0036).
As previously reported, based upon photographic assessment of scars by a lay panel over a time period beginning at week 6 until 7 months post surgery, both trials met their primary endpoints with statistical significance.
As planned in the protocols for both trials, Renovo followed up subjects at the 12 month time point post surgery. Renovo is now announcing the results of this analysis of the new data. Based on a photographic assessment of scars at this single time point, Renovo is pleased to announce that the 50, 200 and 500ng/100uL/linear cm doses were statistically significant, demonstrating a broad dose response window for Juvista.
Consistent with previous findings, the greatest magnitude of efficacy was observed for 500ng/100uL/linear cm wound margin given twice, 24 hours apart (p<0.0001).
The safety and tolerability profile to date continues to support progressing Juvista into Phase 3 development.
Renovo’s Future Plans for Juvista
Juvista is being evaluated in a comprehensive Phase 1 & 2 programme of prophylactic scar reduction involving in total 16 clinical trials. This holistic, not sequential, Phase 2 trial package has been designed to help provide a basis for Phase 3 trial design.
Renovo is on track to commence its first European Phase 3 trial in scar revision surgery in the second half of 2008. As previously announced this trial will likely evaluate two doses of Juvista (200ng and 500ng) given twice, at the time of surgery following wound closure and 24 hours later.
Renovo will provide guidance on the design of this trial and the remainder of the Phase 3 programme for the European Regulatory Filing/Dossier following further consultation with the regulatory authorities.
For further information please contact:
Renovo Professor Mark Ferguson, Chief Executive Officer +44 (0) 161 606 7222 Simon Bielecki, Vice President, Communications +44 (0) 161 606 7328
Buchanan Communications Mary-Jane Johnson / Tim Anderson / Lisa Baderoon +44 (0) 20 7466 5000
About Renovo Group plc
Renovo is a biopharmaceutical product company and is the world leader in scar reduction research and the development of drugs to reduce scarring.
Renovo has a portfolio of drugs which exploit different novel mechanisms of action to reduce scarring at multiple body sites and to accelerate healing. Juvista®, Renovo’s lead drug for the reduction of scarring in the skin has been safely administered to over 1,500 human subjects and has reported statistical and clinical significance in seven Phase 2 efficacy trials.
Renovo announced in June 2007 that it had signed an exclusive licensing agreement with Shire plc to develop and commercialise Juvista. The agreement covers every country in the world except the European Union, the rights to which have been retained by Renovo. Under the terms of the deal Renovo has already received an initial payment of US$125 million. Contingent on the successful development and commercialisation of Juvista Renovo will be eligible for further payments of up to $700 million together with escalating royalties on sales.
Zesteem®, Renovo’s lead drug for the acceleration of wound healing in the skin is currently being investigated in a Phase 3 clinical trial. Prevascar® reported statistically significant Phase 2 efficacy data for the reduction of scarring in the skin in April 2007 and is additionally being investigated for enhancing regeneration of peripheral nerves following injury or trauma. JuvidexTM is in a Phase 2 trial for the acceleration of healing.