ALNY On Watch, NLNK Exhibits Caution, Keep An Eye On GKOS

(RTTNews) - Today's Daily Dose brings you news about Albireo's pharmacodynamic marker data measured in its completed phase II clinical trial of A4250 in children with cholestatic liver disease and pruritus; Alnylam's new results from its phase 1 and Phase 1/2 trials of Givosiran for the treatment of acute hepatic porphyrias; encouraging data from Glaukos' Investigational Device Exemption pivotal trial of iStent inject Trabecular Micro-Bypass System, and NewLink's decision on its IDO pathway inhibitor Indoximod.

Read on…

Albireo Pharma Inc. (ALBO) on Saturday presented results on a pharmacodynamic marker measured in its completed phase II clinical trial evaluating lead product candidate A4250 in children with cholestatic liver disease and pruritus.

In the study, treatment with A4250 decreased ATX (lysophospholipase autotoxin) levels in most patients, and there was a statistically significant correlation with a reduction in serum bile acids. The level of ATX and its product, lysophosphatic acid, have been shown to be increased in patients with pruritus due to cholestasis.

Pruritus intensity at baseline was significantly correlated with baseline levels of ATX Correlations between reduction in ATX and reduction in pruritus did not reach statistical significance.

The Company looks forward to commencing its phase III clinical trial of A4250 for the treatment of patients with progressive familial intrahepatic cholestasis this spring.

ALBO closed Friday's trading at $33.94, up 0.62%.

Alnylam Pharmaceuticals Inc. (ALNY) has announced new results from its phase 1 and Phase 1/2 open-label extension studies of its investigational RNAi therapeutic Givosiran for the treatment of acute hepatic porphyrias.

In the phase I study, monthly Givosiran demonstrated more than 80 percent lowering of urinary aminolevulinic acid (ALA), a disease biomarker, and more than 75 percent decrease in mean annualized porphyria attack rate, relative to placebo.

Acute hepatic porphyrias (AHPs) are a family of rare, genetic diseases characterized by potentially life-threatening attacks and for many patients chronic debilitating symptoms that negatively impact daily functioning and quality of life.

In the ongoing phase 1/2 Open-Label Extension (OLE) Study, patients treated with Givosiran experienced greater than 90 percent decrease in mean annualized porphyria attack rate, relative to baseline run-in attack rate.

ALNY closed Friday's trading at $100.76, up 0.01%.

AstraZeneca plc (AZN) and Merck & Co. Inc. (MRK) presented updated overall survival data for LYNPARZA from OlympiAD trial.

The OlympiAD trial is a phase III study, which involved patients who had germline BRCA-mutated, HER2-negative (hormone receptor-positive or triple negative) breast cancer, and it formed the basis for FDA approval of LYNPARZA in January 2018.

According to the updated findings, the median overall survival was 19.3 months in patients treated with LYNPARZA and 17.1 months for patients treated with chemotherapy.

The results of the OlympiAD trial were originally reported last August, and the data demonstrated that median progression-free survival in the LYNPARZA-treated group was 7.0 months, significantly longer than in the standard-therapy group, which was 4.2 months. The response rate was 59.9% in the LYNPARZA group and 28.8% in the standard-therapy group.

AZN closed Friday's trading at $36.32, down 0.11%.

Glaukos Corp.'s (GKOS) two-year U.S. Investigational Device Exemption pivotal trial data has shown that its iStent inject Trabecular Micro-Bypass System achieved a statistically significant reduction in unmedicated diurnal intraocular pressure in patients undergoing cataract surgery.

The study involved 387 subjects who were randomized to iStent inject in combination with cataract surgery, and 118 subjects were randomized to cataract surgery only. Subjects were followed through 24 months with annual medication washouts.

According to trial results, at 24 months, 75.3% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP, compared to 61.9% for the cataract-only cohort.

At 24 months, the mean unmedicated IOP reduction was 6.9 mmHg for the iStent inject cohort, compared to 5.4 mmHg for the cataract-only cohort.

The iStent inject is commercially available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa. But it is not approved for use in the U.S.

Glaukos submitted a pre-market approval application for the iStent inject to the FDA in December 2017.

GKOS closed Friday's trading at $27.62, down 9.94%.

Merck's (MRK) phase III study investigating its blockbuster drug KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma has shown that KEYTRUDA significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 43 percent compared to placebo in the overall study population.

Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, Merck Research Laboratories, said, "These are the first data for KEYTRUDA in the adjuvant setting and mark an important advancement for the treatment of resected stage III melanoma".

Merck has a broad clinical development program in melanoma with KEYTRUDA as monotherapy and in combination with other novel mechanisms. The program, which is comprised of more than 4,500 patients across 10 clinical studies, is evaluating KEYTRUDA across all settings and stages of the disease.

MRK closed Friday's trading at $57.17, up 0.76%.

NewLink Genetics Corp.'s (NLNK) initial data from a phase I study evaluating Indoximod in combination with radiation and chemotherapy for the treatment of pediatric patients with diffuse intrinsic pontine glioma, a type of progressive brain tumor, indicate Indoximod has clinical activity, with minimal toxicity.

Indoximod is an IDO pathway inhibitor. The IDO pathway provides a direct defense against T cell attack.

Separately, the Company announced that it will not initiate the randomization portion of Indigo301, its phase III study of Indoximod or placebo plus KEYTRUDA or OPDIVO for patients with unresectable or metastatic melanoma in the context of the failure of a competitor's trial of its enzymatic IDO inhibitor in a similar clinical setting.

On April 6, 2018, a late-stage study combining Incyte's IDO inhibitor Eepacadostat and Merck's Keytruda to treat people with metastatic melanoma had failed to meet the primary endpoint of improving progression-free survival.

NLNK closed Friday's trading at $4.47, down 0.67%.