Gilead, Galapagos filgotinib shows sustained benefit in RA studies

Gilead Sciences (NASDAQ:GILD) and collaboration partner Galapagos NV (NASDAQ:GLPG) announce week 52 results from two Phase 3 clinical trials, FINCH 1 and FINCH 3, evaluating JAK1 inhibitor filgotinib in adults with moderately to severely active rheumatoid arthritis (RA). The data are being virtually presented at EULAR.

80.7% (n=1,417/1,755) of participants in FINCH 1 completed 52 weeks of treatment. Both doses of filgotinib showed sustained efficacy in primary and secondary outcome measures. A greater proportion of patients in the 200 mg filgotinib arm achieved low disease activity and clinical remission compared to patients receiving adalimumab [AbbVie’s (NYSE:ABBV) Humira].

78.1% (n=975/1,249) of patients in FINCH 3 completed 52 weeks of treatment. All showed sustained efficacy through week 52 based on clinical response, physical function and radiographic progression. Higher proportions of patients in the filgotinib 200 mg + methotrexate, 100 mg + methotrexate and filgotinib 200 mg monotherapy arms achieved ACR20 (20% improvement in RA symptoms), ACR50, ACR70 and disease remission compared to methotrexate alone. Patients receiving filgotinib showed less progression of structural damage compared to methotrexate monotherapy.

No new safety signals were observed in either study.

Marketing applications have been filed in the U.S., Europe and Japan for the indication.

https://seekingalpha.com/news/3580332-gilead-and-galapagos-filgotinib-shows-sustained-benefit-in-ra-studies

Late-stage gastric cancer study of Chi-Med’s fruquintinib to continue

Hutchison China MediTech Limited (Chi-Med) (NASDAQ:HCM) announces that its Phase 3 clinical trial, FRUTIGA, evaluating fruquintinib, combined with Taxol (paclitaxel), in patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have progressed after first-line chemo, will continue without modification. The action was based on a planned interim data review by the independent Data Monitoring Committee.

Fruquintinib starves tumors of their blood supply via inhibiting vascular endothelial growth factor receptors (VEGFR) 1, 2 & 3, which play key roles in tumor-related angiogenesis (formation of new blood vessels).

The drug was approved in China in September 2018 and was commercially launched there by Eli Lilly (NYSE:LLY) under the brand name Elunate for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type).

Chi-Med retains all rights to fruquintinib ex-China.

https://seekingalpha.com/news/3580344-late-stage-gastric-cancer-study-of-chi-meds-fruquintinib-to-continue

FDA clears new B + L contact lenses

The FDA issues 510(k) clearance for Bausch Health Companies (NYSE:BHC) unit Bausch + Lomb’s INFUSE daily disposable silicone hydrogel contact lenses.

B + L says INFUSE lenses feature a next-generation material called kalifilcon A that delivers “outstanding” breathability for healthy lens wear while providing all-day comfort and high definition optics.

https://seekingalpha.com/news/3580357-fda-clears-new-b-l-contact-lenses

Vapotherm to scale up production for nasal cannula systems for COVID-19

Vapotherm (NYSE:VAPO) announces expansion in its capital equipment manufacturing capabilities.

This increased capacity is anticipated to increase production of its Precision Flow systems by up to 20X above pre-COVID-19 levels.

At maximum capacity, the increased production could create up to an additional 350 jobs at its New Hampshire facility.

This scaling up is in response to a potential increase in demand for the company’s Precision Flow Hi-VNI system, an advanced high-flow nasal cannula system used to treat the respiratory distress experienced by COVID-19 patients.

https://seekingalpha.com/news/3580371-vapotherm-to-scale-up-production-for-nasal-cannula-systems-for-covidminus-19

Anavex on go to expand Anavex 2-73 study in Alzheimer’s

Anavex Life Sciences (NASDAQ:AVXL) has received a No Objection Letter from Health Canada and Medicines and Healthcare products Regulatory Agency in the UK to expand the Phase 2b/3 study of ANAVEX2-73-AD-004 of ANAVEX 2-73 (blarcamesine) for the treatment of early Alzheimer’s disease (AD) into Canada and the UK, respectively.

The 48-week study using biomarker and precision medicine in 450 patients with early AD is ongoing and currently over 50% enrolled.

https://seekingalpha.com/news/3580384-anavex-on-go-to-expand-anavex-2minus-73-study-in-alzheimers

Can-Fite advancing Namodenoson in liver cancer

Subsequent to a meeting with the EMA, Can-Fite BioPharma Ltd. (NYSEMKT:CANF) says it now has sufficient regulatory guidance to conduct a pivotal Phase 3 clinical trial evaluating Namodenoson in hepatocellular carcinoma patients with Child Pugh Class B7 (moderately severe) cirrhosis.

The primary endpoint of the 450-subject study will be overall survival (OS).

Namodenoson failed to beat placebo in OS in a Phase 2 trial.

https://seekingalpha.com/news/3580387-can-fite-advancing-namodenoson-in-liver-cancer

FDA OKs use of Aldeyra Therapeutics’ RASP in dry eye disease

Aldeyra Therapeutics (NASDAQ:ALDX) reaches an agreement with the FDA for the use of RASP (reactive aldehyde species) as an objective sign for the treatment of dry eye disease.

RASP are pre-cytokine pro-inflammatory mediators that are elevated in the tears of patients with dry eye disease, and correlate with dry eye disease symptoms and signs.

RASP inhibitor, reproxalap, when administered topically to the eye has demonstrated statistically significant and clinically relevant activity in dry eye disease, allergic conjunctivitis, and other forms of ocular inflammation across numerous Phase 2 and Phase 3 clinical trials.

Further updates on development plans and remaining NDA requirements for reproxalap in dry eye disease will be provided in July 2020.

https://seekingalpha.com/news/3580394-fda-oks-use-of-aldeyra-therapeutics-rasp-in-dry-eye-disease