Placebo

Recruitment and Enrollment Underway at Eight Sites for Innovation Pharma’s Phase 2 Clinical Trial of Brilacidin for COVID-19

Friday, March 5, 2021 - 4:31pm

The trial is now posted on clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT04784897 ), which shows seven sites as recruiting and enrolling patients.

Key Points: 
  • The trial is now posted on clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT04784897 ), which shows seven sites as recruiting and enrolling patients.
  • We are pleased to see patient recruitment and enrollment in our Brilacidin for COVID-19 clinical trial ramping up, said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
  • The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19.
  • The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients.

Ocuphire Announces Publication of MIRA-1 Phase 2b Results in Optometry and Visual Science Demonstrating Reduction of Pharmacologically Induced Mydriasis by Nyxol®

Friday, March 5, 2021 - 1:44pm

The continued peer-reviewed publications of our Nyxol clinical trial results allow us to highlight the iris dilator mechanism and emerging product profile of Nyxol.

Key Points: 
  • The continued peer-reviewed publications of our Nyxol clinical trial results allow us to highlight the iris dilator mechanism and emerging product profile of Nyxol.
  • The recently enrolled MIRA-2 Phase 3 pivotal trial leveraged the design and findings of the MIRA-1 Phase 2b trial, said Mina Sooch, MBA, President and CEO of Ocuphire Pharma.
  • Treatment with Nyxol eye drops led to a reduction in time to return to baseline pupil diameter of nearly 2 hours when compared to placebo.
  • The MIRA-1 results informed the trial design of the Phase 3 MIRA-2 registration trial that recently completed recruitment.

Relivion® Wearable Brain Neuromodulation Technology Cleared by FDA for the Treatment of Migraine

Tuesday, March 2, 2021 - 2:01pm

Relivion is the first non-invasive multi-channel brain neuromodulation system for at home treatment of acute migraine, a debilitating neurological disease impacting 39 million people and resulting in 1.2 million emergency department visits annually.

Key Points: 
  • Relivion is the first non-invasive multi-channel brain neuromodulation system for at home treatment of acute migraine, a debilitating neurological disease impacting 39 million people and resulting in 1.2 million emergency department visits annually.
  • This allows for the release of neurotransmitters in the brainstem and modulation of brain networks associated with control of pain.
  • The FDA marketing clearance is based on the results of a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study.
  • Neuroliefs technology is currently being utilized for patients with migraine and being studied for patients with major depression.

BiomX Announces Dosing of First Subject in Phase 2 Study of BX001 for Acne-Prone Skin

Tuesday, March 2, 2021 - 12:00pm

The aim of the study is to provide clinically meaningful improvement of the appearance of acne-prone skin.

Key Points: 
  • The aim of the study is to provide clinically meaningful improvement of the appearance of acne-prone skin.
  • The initiation of this study with BX001 marks an important inflection point in the Companys growth as this is our first Phase 2 clinical study, said Jonathan Solomon, Chief Executive Officer of BiomX.
  • We are encouraged by our prior positive Phase 1 results, in which the BX001 phage cocktail demonstrated a statistically significant reduction of C. acnes levels compared to placebo.
  • The Phase 2 cosmetic clinical study is a 12-week randomized, single center, double-blind, placebo-controlled trial in 140 individuals with mild-to-moderate acne vulgaris.

Allakos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

Monday, March 1, 2021 - 1:00pm

Announced positive safety, pharmacokinetic and pharmacodynamic results from a randomized, double-blind, placebo-controlled Phase 1 study of subcutaneous (SC) lirentelimab in healthy volunteers.

Key Points: 
  • Announced positive safety, pharmacokinetic and pharmacodynamic results from a randomized, double-blind, placebo-controlled Phase 1 study of subcutaneous (SC) lirentelimab in healthy volunteers.
  • The pharmacokinetic and pharmacodynamic results suggest that SC lirentelimab may be given monthly or potentially less frequently.
  • Net loss per basic and diluted share was $0.86 for the fourth quarter of 2020 compared to $0.51 in the same period in 2019.
  • These documents contain and identify important factors that could cause the actual results forAllakosto differ materially from those contained in Allakos forward-looking statements.

Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

Thursday, February 25, 2021 - 2:00pm

Atossas assessment is that AT-301 nasal spray was safe and well tolerated in this study.

Key Points: 
  • Atossas assessment is that AT-301 nasal spray was safe and well tolerated in this study.
  • The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.
  • Following that, we expect to apply to the FDA to commence a Phase 2 study here in the United States.
  • The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were divided into two study groups.

BioAge Initiates Phase 2a Trial of BGE-117 in Elderly Patients with Unexplained Anemia

Thursday, February 25, 2021 - 1:00pm

BioAge Labs, Inc., a clinical-stage biotechnology company developing medications that target aging to treat severe diseases, today announced that it has commenced a Phase 2a clinical trial of BGE-117, an activator of hypoxia signaling, for unexplained anemia of aging (UAA).

Key Points: 
  • BioAge Labs, Inc., a clinical-stage biotechnology company developing medications that target aging to treat severe diseases, today announced that it has commenced a Phase 2a clinical trial of BGE-117, an activator of hypoxia signaling, for unexplained anemia of aging (UAA).
  • In this randomized, placebo-controlled, double-blind, multi-center Phase 2a trial, 160 UAA patients 65 years or older will receive daily oral doses of BGE-117 or placebo (80 patients in each group) for 3 months.
  • In 33% of elderly patients, anemia cannot be attributed to iron deficiency or underlying medical conditions; accordingly, these cases are classified as unexplained anemia of aging (UAA).
  • The pharmacoeconomic burden is considerable: in elderly anemic patients, Medicare costs for falls alone are several billion dollars per year.

Chimerix Reports Promising Topline Results from First Cohort of a Randomized COVID-19 Trial with DSTAT

Thursday, February 25, 2021 - 12:00pm

The fact this is a blinded, randomized trial provide a higher level of confidence than open label single arm studies.

Key Points: 
  • The fact this is a blinded, randomized trial provide a higher level of confidence than open label single arm studies.
  • The second cohort of 12 patients, which is randomized 2:1 and explores a higher dose of DSTAT is now fully enrolled and we look forward to reporting topline data from this cohort in the second quarter.
  • All six DSTAT patients met the improvement criteria compared to two of the six placebo patients as shown in the Kaplan-Meier curve below.
  • The median age of patients in cohort one was 63.0 years on the placebo arm and 50.5 years on the DSTAT arm.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against QuantumScape, Tricida, Penumbra, and Lizhi and Encourages Investors to Contact the Firm

Wednesday, February 24, 2021 - 10:00pm

Specifically, it stated that the batterys power means it will only last for 260 cycles or about 75,000 miles of aggressive driving.

Key Points: 
  • Specifically, it stated that the batterys power means it will only last for 260 cycles or about 75,000 miles of aggressive driving.
  • On this news, the Companys stock price fell $34.49, or approximately 40.84%, to close at $49.96 per share on January 4, 2021.
  • Tricida has completed a Phase 3, double-blind, placebo-controlled trial of veverimer in patients with CKD and metabolic acidosis.
  • For more information on the Lizhi class action go to: https://bespc.com/cases/LIZI
    About Bragar Eagel & Squire, P.C.

New Phase 3 Clinical Study Finds Nutritional Protocol Including Nicotinamide Riboside Accelerates Recovery in Mild-to-Moderate COVID-19 Patients

Wednesday, February 24, 2021 - 11:30am

The Phase 3 study demonstrated that patients with mild-to-moderate COVID-19 receiving standard of care experienced a 3.5 day reduction in recovery time when receiving an added nutritional protocol.

Key Points: 
  • The Phase 3 study demonstrated that patients with mild-to-moderate COVID-19 receiving standard of care experienced a 3.5 day reduction in recovery time when receiving an added nutritional protocol.
  • Aimed at improving mitochondrial function, the protocol included nicotinamide riboside (NR), L-serine, N-acetyl-L-cysteine (NAC), and L-carnitine tartrate.
  • The randomized, placebo-controlled, and double-blind Phase 3 clinical trial studied 309 outpatients at Umraniye Teaching and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  • Patients received standard of care for 5 days and the nutritional protocol or placebo for 14 days.