BioSpace Global Roundup, Oct. 10

DBV Technologies – The U.S. Food and Drug Administration accepted DBV’s Biologics License Application for its Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages four to 11 years. Viaskin Peanut, a non-invasive, once-daily, epicutaneous patch, is the France-based company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts. The target action date provided by the FDA is Aug. 5, 2020. The FDA has communicated that it is currently planning to hold an advisory committee meeting to discuss the Viaskin Peanut application.  Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including two Phase I clinical trials, four Phase II clinical trials, and two Phase III clinical trials.

Haselmeier – Switzerland-based Haselmeier and Italy-based Stevanato Group announced an exclusive agreement to license the Axis-D pen-injector technology and intellectual property (IP) for the development, manufacturing and supply of the Axis-D pen-injector in the Therapeutic Area of Diabetes Care, the companies announced. The Axis-D pen-injector was designed and developed by Haselmeier. A new injector is in the works and once the design is finalized, it will be produced at one of Stevanato Group’s manufacturing facilities, based on extensive tooling and molding expertise. Sub-assembly and final assembly equipment will be provided by Stevanato Group operations in Denmark.

Summit Therapeutics – Oxford, U.K.-based Summit Therapeutics presented new data to explain a link between the findings of the company’s Phase II trial of ridinilazole for C. difficile infection. In the trial, ridinilazole demonstrated superior efficacy compared to vancomycin, driven by a 60% lower recurrence rate. Also, ridinilazole preserved the diversity of the gut microbiome. The findings are connected mechanistically by bile acids, part of the “metabolome” of active chemicals made or modified by gut bacteria, the researchers said. Bile acids exist in different forms that can either favor or block the regrowth of C. difficile after treatment. Ridinilazole leaves these bacteria unharmed, allowing them to keep converting pro-C. difficile bile acids into anti-C. difficile bile acids, maintaining a positive chemical balance that prevents C. difficile recurrence, the company said. Data from the Phase II trial showed that patients who were treated with ridinilazole saw a statistically significant improvement in sustained clinical responses.

Prepscan – Netherlands-based Prepscan announced its GMP production capacity has doubled. The doubled GMP production capacity enables Prepscan to guarantee short production timelines. It also gives clients the benefit of collaborating with a single expert partner on the way from R&D to the clinic, resulting in maximum efficiency while also saving time. The company’s production line consists of a new synthesizer, a preparative HPLC and lyophilizer in the cleanroom.

GenSight Biologics – France-based GenSight reported positive proof of GS010 DNA transfer from one eye to the other eye following unilateral intravitreal injection of primates. In a non-clinical study to investigate the local biodistribution of GS010, tissue samples from the non-injected eye of monkeys that had been unilaterally injected with GS010 were found to contain GS010 DNA three months after injection, indicating the expression of the therapeutic gene in the contralateral eye, the company announced. The study was initiated to investigate potential mechanisms behind the unexpected contralateral effect seen in two of GS010’s Phase III trials, REVERSE and RESCUE, the company noted. As previously reported, both trials, which this year completed the two-year follow-up of patients unilaterally injected with GS010, documented sustained bilateral improvements in LogMAR mean visual acuity. The contralateral effect did not conform to expectations for gene therapies administered to only one eye.

Galderma – Switzerland-based Galderma announced results from its Phase II clinical trial of the investigational botulinum toxin, QM1114. The company said the asset his the mark in the treatment of glabellar lines (frown lines) and plans for a Phase III trial are underway. QM1114, which was derived from Galderma's proprietary strain of Clostridium botulinum bacteria, has been developed specifically for use in aesthetics. In addition to the Phase II news, Galderma received the go-ahead from the Swedish Medical Products Agency for a new state-of-the-art manufacturing facility at the Center of Excellence, located in Uppsala, Sweden. This new facility, built to the highest quality standards, is designed exclusively to meet the production and safety requirements of QM1114. It will also ensure that Galderma can meet increasing worldwide demand as the company's innovative aesthetics pipeline grows, the company said.

Samsung Bioepis – Korea-based Samsung Bioepis announced real-world data of Benepali in patients with moderate to severe psoriasis. The results will be presented at the 2019 European Academy of Dermatology and Venereology (EADV) Congress in Madrid, Spain. The study included patients treated with Benepali and results showed that the medication was effective when used by patients in real-world settings, the company said. Full results will be presented Thursday at the conference. Samsung Bioepis and Biogen were the first to launch biosimilars of the three most prescribed anti-TNF therapies for immunological diseases across Europe: etanercept, infliximab and adalimumab.

Minoryx Therapeutics – CNS specialist Minoryx Therapeutics, based in Spain, completed recruitment for its Phase II trial assessing its PPAR agonist leriglitazone (MIN-102), in patients with Friedreich’s Ataxia. The FRAMES trial will treat 39 patients from four European companies with a primary endpoint of monitoring the effect of the medication on disease progression. This endpoint will be measured through state-of-the-art imaging of the spinal cord. Secondary objectives include safety and tolerability, effect on additional clinical measures, such as patient-reported outcomes, functional disability scores and exploratory biomarkers. Leriglitazone has also proven to be effective in in vivo models of other CNS diseases and is currently in a pivotal Phase II/III clinical trial for the treatment of adrenomyeloneuropathy, the most common phenotype of X-linked adrenoleukodystrophy.