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Monday, October 14, 2019

Bayer to back 11 international startups in various digital health enterprises

Bayer has signed onto sprawling new collaborations with 11 digital health startups spanning areas such as oncology, ophthalmology, pulmonology, radiology, digital therapeutics and cardiovascular health.
Formerly known as its Grants4Apps partnership program, the German pharma has consolidated the group’s digital health initiatives under the name G4A—pledging financial funding and research assistance. The 11 participants were chosen out of over 750 applications from 65 countries, the company said.
The program also paves the way for longer-term collaborations, including commercial development support to bring the digital health products to market, said Zsuzsanna Varga, head of Bayer’s G4A program, which is divided into two different pathways.
The “Growth Track” grants early-stage startups €75,000 ($82,700 U.S.) for co-creating products, plus co-working space and mentoring at Bayer’s pharmaceuticals division headquarters in Berlin. Meanwhile, the “Advance Track” includes startups looking to co-create and execute commercial deals and includes incremental milestone-based payments.
The Growth Track includes the U.K.’s Okko Health, developer of personalized smartphone software for remote monitoring of visual health. Wellthy Therapeutics, based in India, is working on behavioral interventions focused on chronic diseases. Litesprite, in the U.S., creates mobile games to help users manage stress, anxiety and depression.
Germany’s Visotec is building a handheld, at-home optical coherence tomography scanner, while BioLum Sciences in the U.S. is developing a low-cost, point-of-care device to analyze airway inflammation. Upside Health in New York has made an app for chronic pain management, employing cognitive behavioral therapy and other resources.
On the Advance Track, the startups include Prevencio Med, a U.S.-based developer of blood tests and algorithms to predict a person’s risk of heart disease; Blackford Analysis in the U.K., with its marketplace of medical image analysis apps and AI algorithms; Canada’s NeuroTracker, makers of a cognitive training program; Carepay, a Kenya-based mobile health payment platform; and RelianceHMO, a health insurance company using data science and telemedicine in Nigeria.
Additionally, Bayer recently spun its artificial intelligence imaging collaboration with the U.K.’s Sensyne Health into a full-fledged LifeHub project, joining its innovation centers in Lyon, France, Berlin, Boston, California, Singapore and Tokyo and Osaka, each centered on its own area of expertise.
https://www.fiercebiotech.com/medtech/bayer-to-back-11-startups-various-digital-health-enterprises

J&J Vision nets FDA approval for wavefront-guided PRK laser eye surgery

Johnson & Johnson Vision has secured FDA approval for a new laser eye surgery indication for its iDesign Refractive Studio system.
In addition, the company unveiled plans for the U.S. rollout of a preloaded, disposable delivery system for its Tecnis intraocular lenses for cataract patients. The announcements were made at the annual meeting of the American Academy of Ophthalmology in San Francisco.
The new indication covers wavefront-guided photorefractive keratectomy, or PRK eye surgery, as an alternative to LASIK for the treatment of nearsightedness. J&J Vision said it plans to make the upgrade available through a software update in the first quarter of 2020. The iDesign system previously received approvals for myopia and hyperopia, both with or without astigmatism, as well as monovision LASIK procedures.
Wavefront-guided PRK and LASIK procedures allow for more personalized corrections during refractive surgery, according to the AAO. In new clinical data presented at the meeting, J&J Vision said that 99% of patients achieved 20/16 or better vision at six months following the procedure.
Meanwhile, the company said its FDA-approved Tecnis Simplicity lens delivery system is now available in the U.S. The preloaded and disposable device is designed to prevent loading errors and protect the one-piece intraocular lens against contamination, according to J&J Vision.
Additionally, J&J Vision debuted the CHiME inventory management system for ophthalmology practices. The program and accompanying supply cabinet aims to automate product processing and ordering while tracking expiration dates. The company said it plans to pilot the system at several U.S. practices over the next few months.

PolarityTE up on positive SkinTE data

Thinly traded nano cap PolarityTE (NASDAQ:PTE) is up 8% premarket on light volume in reaction to positive results from an open-label single-arm pilot study evaluating SkinTE for closing venous stasis leg ulcers (VLUs) that have not responded to convention treatments. The data were presented at the Symposium on Advanced Wound Care Fall Meeting in Las Vegas.
10 patients with VLUs that remained open after at least one month of conventional treatments participated. After receiving SkinTE, an autologous, homologous human cellular and tissue-based product, 80% of the VLUs closed within 12 weeks. 100% of the VLUs showed graft take and initial signs of closure.
A 100-subject Phase 1 trial is in process with an estimated completion date in September 2020.
https://seekingalpha.com/news/3505477-polarityte-8-percent-premarket-positive-skinte-data

Pfenex up on positive human factor data on PF708

Thinly traded micro cap Pfenex (NYSEMKT:PFNX) is up 2% premarket on light volume in response to results from a human factors study that showed the non-inferiority (no worse than) of the user interface of PF708 to Eli Lilly’s (NYSE:LLY) Forteo [teriparatide (rDNA origin) injection].
The company says the data complete the information package required by the FDA to assess the therapeutic equivalence of PF708. Alvogen will manufacture and commercialize in the U.S.
The FDA approved the Forteo biosimilar last week under its 505(b)(2) pathway but requested the human factors study to complete the data package.
https://seekingalpha.com/news/3505486-pfenex-2-percent-premarket-positive-human-factor-data-pf708

Lilly’s Taltz successful in late-stage pediatric psoriasis study

A 201-subject Phase 3 clinical trial, Ixora-peds, evaluating Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab) in children and adolescents aged six to less than 18 years old with moderate-to-severe plaque psoriasis met both co-primary endpoints. The results were presented at the European Academy of Dermatology and Venereology Congress in Madrid.
89% of treated patients achieved at least a 75% improvement from baseline to week 12 in Psoriasis Area and Severity Index score (PASI 75). 81% achieved clear or almost clear skin (static PGA 0,1) at week 12.
All major secondary endpoints were also met. No new safety signals were observed.
Taltz is not yet approved for pediatric use. The FDA OK’d the IL-17A inhibitor for adults with plaque psoriasis in May 2016.
https://seekingalpha.com/news/3505416-lillys-taltz-successful-late-stage-pediatric-psoriasis-study

Flexion down on extension of FDA action date for repeat injections of Zilretta

Flexion Therapeutics (NASDAQ:FLXN) slips 2% premarket on light volume in response to an extension of the FDA’s action date for its review of its application seeking approval for repeat injections of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with knee pain due to osteoarthritis. The PDUFA date was today.
The agency has not identified a specific revised action date, but informed the company that its review should be completed in the coming weeks.
Zilretta was first approved in the U.S. in October 2017 (single intra-articular injection).
https://seekingalpha.com/news/3505433-flexion-2-percent-premarket-extension-fda-action-date-repeat-injections-zilretta

Cara to increase enrollment in second late-stage study of Korsuva in CKD-aP

Based on an interim statistical analysis by the Independent Data Monitoring Committee, Cara Therapeutics (NASDAQ:CARA) will boost enrollment by ~20% to 430 subjects in its Phase 3 clinical trial, KALM-2, evaluating KORSUVA (CR845/difelikefalin) in patients on dialysis with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) (itchy skin).
The increase is necessary in order to maintain at least 90% statistical power on the primary endpoint (the proportion of patients achieving at least a three-point improvement in a scale called NRS at week 12).
Enrollment should be completed this quarter. The company still expects to file a U.S. marketing application in H2 2020.
Another Phase 3, KALM-1, was successful.
https://seekingalpha.com/news/3505441-cara-increase-enrollment-second-late-stage-study-korsuva-ckd-ap