Development of a drug is a tedious, time-consuming and expensive process, with the journey of the drug from the lab to the pharmacy shelf usually taking around 12 years.
Companies support their filings with trial results and each trial outcome has the potential to move the market. Here are a few companies scheduled to release clinical trial results in the month of March.
1. Regeneron's "ODYSSEY" Toward Cholesterol Treatment
- Company: Regeneron Pharmaceuticals Inc REGN
- Product Candidate: Praluent (alirocumab), a PCSK9 inhibitor
- Indication: For treating cardiovascular events such as coronary heart disease death, non-fatal myocardial infraction, fatal and non-fatal ischemic stroke, unstable angina etc.
- Trial: Phase 3 data from a study dubbed ODYSSEY to be presented in a late-breaking session at the annual meeting of the American College of Cardiology scheduled between March 10 and 12. The trial tested the drug's ability to improve cardiovascular outcomes in patients with elevated LDL cholesterol and an acute coronary event.
- Date Expected: March 10
The drug co-developed by Regeneron and Sanofi SA (ADR) SNY is pitted against Amgen, Inc. AMGN's Repatha. Praluent was approved in 2015 as a second-line treatment to lower cholesterol in adults, who have not responded well to diet and statin treatment.
2. Reviving Savara: Trial Results For Heart Failure Drug On Tap
- Company: Savara Inc SVRA
- Product Candidate: Aironite
- Indication: Heart Failure
- Trial: Top-line data of the Phase 2 trial to be presented at the annual meeting of the American College of Cardiology
- Date Expected: 11 a.m. ET on March 11
Aironite is sodium nitrite solution, meant for inhalation via nebulization in patients with heart failure, with preserved ejection fraction, or HFpEF. It's being evaluated in a study dubbed INDIE-HFpEF study.
3. Synlogic to Present Logic Behind Its Hyperammonemia Drug
- Company: Synlogic Inc SYBX
- Product Candidate: SYNB1020
- Indication: to treat elevated ammonia levels or hyperammonemia in genetic urea cycle disorders, or UCDs.
- Trial: Phase 1
- Date Expected: Not specified
SYNB1020 is an orally delivered, synthetic biomedicine to treat elevated blood ammonia levels in UCDs or in chronic lever disease.
The company said in a Jan. 5 release it plans to present full data from the Phase 1 trials at two medical meetings: Society for Inherited Metabolic Disorders Annual Meeting scheduled for March 11-14 in San Diego, and the International Conference on Ureagenesis Defects: Novel Models and Treatment Options, scheduled between March 19-21 in Engadin, Switzerland.
4. Sellas to Present Abstract of Mid-stage Study of Lead Candidate
- Company: Sellas Life Sciences Group Inc SLS
- Product Candidate: Galinpepimut-S
- Indication: Multiple myeloma
- Trial: Phase 2 abstract to be presented at the 2018 European Society for Blood and Marrow Transplantation 44th Annual Meeting scheduled for March 18-21 in Lisbon, Portugal.
- Date Expected: 10:50 a.m. ET on March 19
The company is scheduled to present the abstract as an oral presentation at the EBMT, giving detailed correlative analyses between clinical benefit and antigen-specific immune-responses of the complete data set from the mid-stage study.
Galinpepimut-S is also being tested for acute myeloid leukemia, malignant pleural mesotheliomia and ovarian cancer.
5. ImmunoGen Moving Forward With Forward II Study Presentation
- Company: ImmunoGen, Inc. IMGN
- Product Candidate: Mirvetuximab soravtansine
- Indication: Ovarian cancer and relapsed endometrial cancer
- Trial: Phase 1b Keytruda dose-escalation data due at the Society of Gynecologic Oncology annual meeting
- Date Expected: March 24-27
Under its Forward II trial, Immunogen is testing mirvetuximab in combination with Merck & Co., Inc. MRK's Keytruda and Roche Holding Ltd. (ADR) RHHBY's Avastin.
6. Esperion Gears Up for Two Trial Result Releases
- Company: Esperion Therapeutics Inc ESPR
- Product Candidate: Bempedoic acid
- Indication: Hypercholesterolemia
- Trial: Top-line results from a Phase 3 Study 4 (1002-048) and top-line data from the Phase 2 study (1002-039)
- Date Expected: Not specified
The 1002-048 study tests bempedoic acid in atherosclerotic cardiovascular disease, or ASCVD, patients on ezetimibe and low dose statin background therapy. Meanwhile, the 1002-039 study tests bempedoic acid added-on to a once-monthly injectable PCSK9 inhibitor.
7. AnaptysBio's Trial Results For Peanut Allergy Treatment Candidate
- Company: AnaptysBio Inc ANAB
- Product Candidate: ANB020
- Indication: treating severe adult peanut allergy patients
- Trial: Top-line data of a Phase 2a trial
- Date Expected: Not specified
A Few Others On The Q1 Schedule
- Altimmune Inc ALT – Phase 2 initial data for Nasovax flu vaccine
- Arena Pharmaceuticals, Inc. ARNA – Phase 2 data for Etrasimod to ulcerative colitis
- Gilead Sciences, Inc. GILD – Phase 3 data for HIV treatment cocktail Bictegravir/F/TAF (switching from Triumeg), Phase 3 interim efficacy analysis of gastric cancer treatment GS-9674 and Phase 2 interim analysis of chronic graft versus host disease, cGVHD treatment candidate entospletinib.
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