Drug Discovery and Development Archives - Page 128 of 158

Biogen’s gosuranemab fails in Phase 2 study

Biogen (NSDQ: BIIB) has scrapped its development plans for gosuranemab (BIIB092) after the drug candidate failed to hit the primary endpoint in a Phase 2 trial.

Biogen’s aducanumab made waves recently, becoming the first Alzheimer’s drug to win FDA approval in recent memory. Not all, however, are happy with that fact.

Aducanumab is an amyloid beta-protein inhibitor while gosuranemab was an anti-tau antibody.

In the TANGO Study, gosuranemab did not appear to have a treatment benefit in several measures in the 78-week study. Such measures included the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the Mini-Mental State Examination (MMSE) and the Functional Assessment Questionnaire (FAQ).

Biogen will present the findings from the gosuranemab study at an upcoming medical congress.

The biotech iPierian first developed the antibody, whic…

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

Moderna vaccine highly effective two weeks after first dose

A study published in JAMA involving healthcare workers found that the first dose of Moderna’s (NSDQ:MRNA) COVID-19 vaccine was highly effective at reducing the risk of COVID-19 infections.

In the study, participants received two doses of the vaccine at the recommended 28-day interval. Clinical effectiveness reached 95% for days 15 through 42 of the study. But constraining the window to days 15 to 28 resulted in similar results.

The findings suggest that the vaccine can rapidly reduce the incidence of vaccine-sensitive SARS-CoV-2 infection in healthcare workers.

Even eight days after administration of the first dose, the vaccine yielded greater than 70% efficacy.

The study authors concluded that their findings were in line with aggregated data for the Pfizer-BioNTech BNT162b2 and Moderna’s mRNA-1273 vaccines.

The 42-day study began on Dec. 22, 2020. It involved 4,028 participants.

A number of healthcare workers have made headlines rec…

Why community-based clinical trials in oncology are on the rise

Photo by Andrea Piacquadio from Pexels

Community-based clinical trials are growing more common in oncology for several reasons.

First, drug developers are looking to boost recruitment efforts and address traditional ethnic and economic health disparities in such studies. Second, community hospitals are growing better equipped to participate in such trials. And finally, drug developers are working on expanding the pool of patients they can recruit in such studies.

Traditionally, community cancer centers have sat on the sidelines in terms of clinical trials. Notable academic medical centers such as Massachusetts General Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering and MD Anderson have played a vital role in oncology clinical trials. But the situation is beginning to change for the following reason.

Community hospitals can help address health disparities

Many pharmaceutical and…

Unraveling aducanumab’s impact on pharma remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are six million Alzheimer’s people in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The survey bodes well for the early uptake of the drug, according to Jefferies. But the continued success of aducanumab will require winning over skeptical neurologists and psychiatrists. Several physicians have penned op-ed’s voicing their resistance to the drug in outlets ranting from STAT to the Baltimore Sun. Last Novembe…

Frequency Therapeutics faces growing legal challenges

Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors.

Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving mild to moderately severe sensorineural hearing loss in a Phase 2a study compared to placebo. Previous results from a smaller study had been more positive.

The company’s stock fell from a high of $55.01 on Feb. 19 to $9.55 in mid-day trading on June 15.

Among the law firms filing lawsuits against Frequency Therapeutics is Robbins LLP (San Diego), which recently filed a class-action lawsuit for purchasers of Frequency Therapeutics stock between Nov. 16, 2020 and March 22. That lawsuit alleges that the company misrepresented its FX-322 experimental drug in earnings calls, press releases, SEC …

Otonomy expands Phase 1/2 hearing loss clinical trial

Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients who have difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection.

The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort.

The randomized, double-blind, placebo-controlled Phase 1/2 study will be relatively small, involving approximately 30 hearing loss patients. A total of 20 people will receive OTO-413 with the remainder receiving placebo.

“We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial,” said David A. Weber, president and CEO of Otonomy, in a statement.

OTO-413 is a formu…

Former FDA commissioner Hahn to join VC behind Moderna

Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative.

A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company.

It has, to date, deployed more than $2.4 billion in capital toward founding and growing companies, as well as more than $19 billion of follow-on investments from other institutions. Among the 41 companies comprising Flagship’s ecosystem is Moderna, the maker of the second vaccine to receive FDA emergency use authorization under Hahn’s tenure with the agency.

Hahn, who served as FDA commissioner from 2019 to 2021, having previously held the role of chief medical executive at the University of Texas MD Anderson Cancer Center, will assume the position of chief medical officer and join Flagship’s…

Building a new foundation for oncology clinical trials

Photo by Anna Shvets from Pexels

The COVID-19 pandemic disrupted oncology clinical trials, and drug developers and regulators, including the FDA, continue to look for ways to catalyze clinical trial innovation. The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.

One factor contributing to the evolution of oncology clinical trials is the change in interactions between sponsors and regulatory agencies. “It is materially diffe…

Novavax’s COVID-19 vaccine demonstrates 90% efficacy

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19.

Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial.

According to a news release, the study enrolled 29,960 participants across 119 locations in the U.S. and Mexico to evaluate the efficacy, safety and immunogenicity of the NVX-CoV2373 vaccine. The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline.

Preliminary safety data demonstrated that the vaccine was generally well-tolerated, with severe adverse events low in number and balanced between vaccine and placebo groups. No sing…