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Gilead to Stop GS-5745 Development for Ulcerative Colitis
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Gilead Sciences Inc. (GILD - Free Report) announced that it will discontinue the combined phase II/III study on one of its pipeline candidates, GS-5745 (anti-MMP9 antibody), which was being developed for the treatment of patients suffering from moderate-to-severely active ulcerative colitis. This decision was based on the recommendation of the Data Monitoring Committee (DMC), following a planned interim analysis of unblinded efficacy and safety data, after the first 150 patients of a 1600-patient study were treated for an eight-week induction duration.
The DMC suggested that the study should be stopped early due to meeting the pre-specified futility and efficacy criteria. Moreover, Gilead evaluated the data and found that there is inadequate evidence of treatment benefit in the group of patients who were randomized to receive either one of two doses of GS-5745. However, no safety concerns were observed in this interim analysis.
Gilead noted that other studies that are currently underway on GS-5745 will continue as planned. Ongoing studies include a phase III study on GS-5745 in patients with gastric cancer, a phase II study in patients with gastric cancer in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo and additional phase II studies in patients with moderately-to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis.
The discontinuation of the development of GS-5745 for ulcerative colitis is disappointing. This is the latest in the series of pipeline setbacks faced by Gilead. This January, the company announced the termination of phase II study on simtuzumab for the treatment of idiopathic pulmonary fibrosis, after results demonstrated a lack of treatment benefit. Earlier too, simtuzumab had failed to provide clinical benefit in phase II study, for the treatment of pancreatic cancer, myelofibrosis and colorectal cancer. However, Gilead is currently evaluating the candidate for the treatment of non-alcoholic steatohepatitis and primary sclerosing cholangitis.
Similar pipeline setbacks could adversely impact Gilead, particularly when the company is looking to bring new products to market, and working on diversifying and growing its business beyond antivirals into other therapeutic areas.
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Gilead to Stop GS-5745 Development for Ulcerative Colitis
Gilead Sciences Inc. (GILD - Free Report) announced that it will discontinue the combined phase II/III study on one of its pipeline candidates, GS-5745 (anti-MMP9 antibody), which was being developed for the treatment of patients suffering from moderate-to-severely active ulcerative colitis. This decision was based on the recommendation of the Data Monitoring Committee (DMC), following a planned interim analysis of unblinded efficacy and safety data, after the first 150 patients of a 1600-patient study were treated for an eight-week induction duration.
The DMC suggested that the study should be stopped early due to meeting the pre-specified futility and efficacy criteria. Moreover, Gilead evaluated the data and found that there is inadequate evidence of treatment benefit in the group of patients who were randomized to receive either one of two doses of GS-5745. However, no safety concerns were observed in this interim analysis.
Gilead noted that other studies that are currently underway on GS-5745 will continue as planned. Ongoing studies include a phase III study on GS-5745 in patients with gastric cancer, a phase II study in patients with gastric cancer in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo and additional phase II studies in patients with moderately-to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis.
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The discontinuation of the development of GS-5745 for ulcerative colitis is disappointing. This is the latest in the series of pipeline setbacks faced by Gilead. This January, the company announced the termination of phase II study on simtuzumab for the treatment of idiopathic pulmonary fibrosis, after results demonstrated a lack of treatment benefit. Earlier too, simtuzumab had failed to provide clinical benefit in phase II study, for the treatment of pancreatic cancer, myelofibrosis and colorectal cancer. However, Gilead is currently evaluating the candidate for the treatment of non-alcoholic steatohepatitis and primary sclerosing cholangitis.
Similar pipeline setbacks could adversely impact Gilead, particularly when the company is looking to bring new products to market, and working on diversifying and growing its business beyond antivirals into other therapeutic areas.
Gilead currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector are Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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