FINOX Biotech announced yesterday that the pivotal phase III study with AFOLIA, a biosimilar recombinant Follicle Stimulating Hormone (r-FSH), in patients undergoing assisted reproduction technology (ART), has met its primary endpoint.
AFOLIA demonstrated clinical and statistical equivalence to the reference product, Gonal-F. Equivalence was defined by retrieving similar numbers of oocytes during a standard treatment duration of 10 to 16 days with a fixed dose of r-FSH. The equivalence margins required that the difference in the number of oocytes retrieved not exceed ±2.9 oocytes.
Results prove that AFOLIA is “biosimilar” to Gonal-F : the number of oocytes retrieved were 11.3 in the AFOLIA group, compared to 10.8 in the Gonal-F group. The treatment difference was 0.52 with a 95%CI of -0.81 to 1.79. The pre-defined equivalence margin was met.
Anjan Selz, Chief Executive Officer of FINOX Biotech commented: “I am extremely pleased with the outstanding FIN3001 results. We will be working with the Health Authorities to make this valuable biosimilar medicine available to ART patients as soon as possible. Submission of the registration dossier to the European Health Authorities is expected by the fourth quarter of 2012.”
About the FIN3001 study
FIN3001 is an assessor-blinded, multicenter, phase III study including a total of 410 patients in a 2:1 randomization scheme in favor of AFOLIA. The treatment effect and the safety profile of AFOLIA in controlled ovarian stimulation is compared to the widely used reference medicine, Gonal-F .
Secondary endpoints included the number of days treated with FSH, the total dose of FSH received, the quality of oocytes retrieved, the quality of embryos transferred and other important clinical parameters for ART. The results from the secondary endpoints were also similar in both treatment groups.
About the safety and tolerability of AFOLIA
Both treatment groups showed a similar safety profile. The safety data set comprised 410 patients (randomized 2:1), who received at least one dose of study treatment. Mean exposure to study treatment was identical in both treatment groups. AFOLIA in this patient population was well tolerated. The number of adverse events reported and patients discontinuing treatment due to adverse events was very similar between the two groups.
AFOLIA is a new “biosimilar” medicine that was produced using recombinant DNA technology. Both AFOLIA and the reference product Gonal-F are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. AFOLIA has a number of key beneficial characteristics. i.e. equivalent clinical efficacy and safety vs. Gonal-F , but using a substantially more attractive injector device. The AFOLIA injector pen is a single-use, one-a-day disposable device, which avoids the complications of a multi-use pen. The self-injection process is reduced to only three steps, which enhances ease-of-use and patient acceptance.
About AFOLIA in other clinical development programs
FINOX Biotech has agreed with the US-FDA via a Special Protocol Assessment to conduct a pivotal phase III study (FIN3002) for registration of AFOLIA in the USA. A US IND application has been filed.
Source: Finox Biotech press release