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Gelectin Therapeutics Reaches NASH-CX Trial Milestones


Despite trepidations about potential issues related to drug pricing, the Pharmaceuticals sector is largely upbeat after their recent meeting with President Trump. The segment is expected to benefit from reforms in regulations which are expected to improve profitability and reduce expenses.

Galectin Therapeutics Inc. (NASDAQ:GALT) is one such specialized pharma company which could benefit from regulatory reforms as the Company focuses on developing therapies based on galectin proteins, which are key mediators of biologic function. It is currently working towards deploying its lead compounds for treating liver fibrosis and cancer.

The company announced early this morning that it reached key clinical milestones in its NASH-CX trial, a double blind, placebo-controlled Phase 2b clinical trial which has enrolled 162 NASH cirrhosis patients into the treatment phase.

Galectin Therapeutics further noted that 47 patients have completed all 52 weeks of infusions with the company’s lead compound, GR-MD-02, and 122 patients have completed 26 weeks of infusions.

The company is on track to release top line data for the trial by December of this year. Successful completion of this trial will likely boost the company’s position in the cirrhosis market, which is characterized by a lack of proven therapies.

The main aim of the study is to assess the efficacy of the lead compound, GR-MD-02, in patients with NASH cirrhosis. Secondary end-points include NASH fibrosis stage and percent of fibrotic tissue based on liver biopsy and other non-invasive measures including FibroScan and 13C Methacetin breath test.

The pharma company also elaborated about its financial standing stating that it has enough funding to see It through this year. Galectin Therapeutics also has financial wherewithal to continue with its NASH-CX Phase clinical trial.

Late last year, Galectin Therapeutics had reported receiving $4 million through equity financing. The funding was obtained through two different transactions. It collected $3 million through private placement of its common stock while the remaining $1 million came through the sale of its Series B-3 preferred stock resulting in additional new proceeds.

The Company is also going ahead with its GR-MD-02 trials with them recently announcing positive interim data from a mid-stage Phase 2a study evaluating the drug to treat moderate-to-severe plaque psoriasis.

The 24-week study resulted in demonstrable clinical improvements on PASI (Psoriasis Area and Severity Index), which is used to express the severity of psoriasis. The patient with the most acute symptoms reported a 72% improvement. Galectin's GR-MD-02 drug is also in another study to treat severe atopic dermatitis patients with certain indications.

Shares of GALT have shown steadiness so far this year with the stock price up a little over 1%. This is in stark contract to the last twelve months when shares of GALT lost a quarter of their value. Positive news from the Company as well as increased sector bullishness could lead to some upside for this beaten down biotech in the not too distant future.