Target $10
Thursday, May 16, 2024
ICER Finds ‘Substantial Uncertainties’ in Lykos’ MDMA Trials Ahead of Adcomm
Due to concerns of study bias, the Institute for Clinical and Economic Review on Tuesday said in a draft report that it is unable to accurately assess the net benefit of Lykos Therapeutics’ investigational MDMA-assisted therapy in post-traumatic stress disorder.
The drug price watchdog said that investigators, study therapists and patients held “very strong prior beliefs” about MDMA, which could have affected the recording of harms and benefits of the investigational treatment. The trial therapists and some of its participants were “pulled heavily” from a community interested in the use of psychedelics for psychological benefits, according to the Institute for Clinical and Economic Review (ICER) draft report.
These sentiments about psychedelics “lead the community to engage with them more like a religious movement than pharmaceutical products,” ICER’s draft report concluded, noting that these feelings were not only common among participants but were also sometimes “inculcated in patients participating in the trials.”
ICER said it also had been informed of “pressures” to keep the result of Lykos’ trials “favorable.” Some participants felt that they were pushed to report only the good outcomes while suppressing bad results. ICER cited first-hand and second-hand accounts of “extremely severe negative outcomes” which some trial therapists said were proof of appropriate treatment response.
“Some patients were prevented from entering the long-term follow-up study and felt this was done to keep these negative outcomes out of the data set,” according to ICER.
The watchdog also pointed out that Lykos’ trials were “essentially, unblinded” because the psychedelic effects of MDMA allowed the patients to determine if they were given the active treatment or the control. The MDMA treatment was correctly identified by “nearly all patients” who received it.
In response to ICER’s findings, Lykos said in a public comment folio that it was “disappointed” by the draft report, noting that the watchdog “discounts the significant unmet medical need for patients living with” post-traumatic stress disorder (PTSD).
ICER “relies on a limited number of stakeholder perspectives, and focuses on areas squarely within the FDA’s purview on the evaluation of safety and efficacy of drugs,” according to Lykos.
ICER’s draft report comes as Lykos gears up for an FDA Psychopharmacologic Drugs Advisory Committee meeting set for June 4, 2024. The panel of external experts will discuss Lykos’ application to use the psychedelic compound MDMA as a treatment for adults with PTSD, when used in conjunction with psychotherapy and other supportive mental health interventions.
Galapagos Partners with Blood Centers of America to Decentralize CAR-T Production
Belgian biotech Galapagos announced on Wednesday that it is enlisting Blood Centers of America in its strategic goal of decentralizing the manufacturing of CAR-T cell therapeutics in the United States.
The partners did not disclose the specific financial details of the deal but said it would give Galapagos access to Blood Centers of America’s (BCA) more than 50 community blood centers across 43 states, enabling the biotech to manufacture its CAR-T cancer therapies closer to treatment centers.
The agreement will also allow Galapagos to deploy its decentralized CAR-T manufacturing platform in the U.S., with the ability to deliver “fresh, fit cells with a vein-to-vein time of seven days,” according to the announcement.
Galapagos CEO Paul Stoffels in a statement called Wednesday’s agreement a “major milestone” for the biotech’s expansion in the U.S., enabling it to “establish centers for support of our pivotal studies, with the potential to be used for commercial introduction.”
The partnership will also allow Galapagos to “efficiently scale up decentralized CAR-T therapy manufacturing” by leveraging BCA’s extensive nationwide network of blood centers, whose existing infrastructure will help “harmonize operations” across the U.S.
Through the collaboration, Galapagos is looking to solve many of what it calls the “limitations” of currently available CAR-T therapies and give physicians more control over treatment while also improving patient experience.
Galapagos said it will use BCA’s apheresis capacities as needed. The network of blood centers will also help support site initiations and onboarding, according to the announcement, which will speed up Galapagos’ campaign to decentralize its CAR-T therapies and ensure quality.
Galapagos is currently working on three clinical CAR-T programs. The most mature of these is GLPG5101, which is a CD19-directed therapy currently in Phase II for relapsed or refractory non-Hodgkin lymphoma. It is running another CD19 program called GLPG5201, which is in Phase I for relapsed or refractory chronic lymphocytic leukemia and Richter transformation.
The third program is GLPG5301, a BCMA-directed CAR-T therapy undergoing Phase I assessment for relapsed or refractory multiple myeloma.
The BCA deal follows Galapagos’ previous agreement with Thermo Fisher Scientific, announced in January 2024, for manufacturing and logistics support for the biotech’s hemato-oncology programs in the San Francisco area. In November 2023, Galapagos entered into a similar but separate agreement with Landmark Bio, which will serve as Galapagos’ strategic point-of-care manufacturing partner in Boston.
Roche Sees Early ROI on $2.7B Carmot Buy with Phase I Data for Obesity Candidate
Roche subsidiary Genentech on Thursday unveiled Phase Ib data for its investigational weight-loss treatment CT-388, demonstrating that a once-weekly subcutaneous shot could significantly lower body weight in healthy adults with obesity.
At 24 weeks of follow-up, CT-388 lowered body weight by 18.8% versus placebo. The effect was statistically significant, with a p-value less than 0.001, according to Genentech’s announcement. In addition, 100% of treated patients showed more than 5% weight loss at 24 weeks, while 45% of participants lost more than 20% of their body weight.
A subgroup analysis also showed that all pre-diabetic participants at the start of the study achieved normal blood glucose levels after 24 weeks of treatment, while those in the placebo group saw no meaningful change in glycemic status.
In terms of safety, CT-388 was well-tolerated in the Phase Ib study with most of its side effects classified as mild to moderate in severity. There were also no unexpected safety signals and CT-388’s adverse event profile was consistent with other medications in the incretin drug class.
Levi Garraway, CMO and head of global product development at Roche, in a statement called Thursday’s data “highly encouraging” for CT-388 and further “underscore its potential to become a best-in-class therapy with durable weight loss and glucose control.” The company will continue to develop the candidate as a treatment for obesity and type 2 diabetes.
Initially developed by Carmot Therapeutics, CT-388 is a dual agonist of the GLP-1 and GIP receptors that shows none or minimal recruitment of β-arrestin proteins, which would otherwise interfere with the receptors’ downstream signaling cascades and dampen the overall therapeutic effects of the obesity treatment, according to Carmot’s website.
CT-388’s biased mechanism of action allows it to prevent or lower desensitization to treatment, prolonging its pharmacological activity. CT-388 is designed to be delivered via a once-weekly subcutaneous injection.
Roche acquired Carmot for $2.7 billion in December 2023 and is now running a multi-part, multi-cohort Phase I trial of CT-388 in overweight or obese patients with or without obesity.
In addition to CT-388, the Carmot deal gave Roche other promising obesity candidates including the Phase II CT-868, which is also a dual agonist of the GLP-1 and GIP receptors but is designed as a daily subcutaneous injection. Roche also owns the early-stage CT-996, which is an oral small molecule GLP-1 agonist.
Thursday’s readout makes Roche a potential contender in the lucrative obesity market, which is currently dominated by Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide). Despite efforts from the frontrunners to boost their manufacturing capacities, they are both still unable to keep up with the market’s voracious appetite for weight-loss treatments, causing protracted drug shortages.
Wednesday, May 15, 2024
Former contractor says EPA took 5 days to deploy chem detection plane in East Palestine
A former Environmental Protection Agency (EPA) contractor who was involved in the creation of a program used to collect environmental data from the air has alleged that the agency delayed deployment of the plane for five days following the 2023 derailment of a train carrying hazardous chemicals in East Palestine, Ohio.
In a NewsNation interview, Robert Kroutil alleged that the EPA took days to deploy its Airborne Spectral Photometric Environmental Collection Technology (ASPECT) plane, used to collect unusual chemical or radiological signals in the air. Kroutil, who was involved in the development of ASPECT for both the Defense Department and the EPA, said typical EPA protocol is to deploy the plane within hours of an incident.
“We should be there at least two weeks to monitor the situation [and] that did not happen” in East Palestine, Kroutil told NewsNation’s Rich McHugh.
NewsNation is owned by Nexstar, along with The Hill.
No one was hurt or injured in the Feb. 6 crash, in which a Norfolk Southern-operated train spilled toxic substances into the area. However, residents have reported rashes and unexplained illnesses in the aftermath.
The surrounding area was briefly evacuated. Local officials conducted a controlled burn on the derailed cars in hopes of averting an explosion.
“We only were deployed for two missions on February 7. And by that time the [chemical] plumes were out, the fire was out,” Kroutil said. “The aircraft actually only collected data, eight minutes worth of data over the targets.”
In an affidavit dated May 13, Kroutil alleged that “[w]e had equipment that could have answered a lot of questions and saved exposure in East Palestine — even prevented the vent and burn — but it was not deployed and operated to collect that information in a timely manner and did not use the correct methods.”
Kroutil’s claims echo testimony by National Transportation Safety Board Chair Jennifer Homendy, who told Sen. JD Vance (R-Ohio) in March that Norfolk Southern contractors “lacked the scientific background” to deem the controlled burn necessary.
An EPA spokesperson told The Hill in an email that weather conditions prevented deploying the ASPECT aircraft on Feb. 6, the day of the controlled burn, and that data was collected the following day in a manner “consistent with previous ASPECT responses.”
“Within hours of the derailment on February 3, EPA responders were on-scene establishing a robust air monitoring network at the site and within the community. EPA’s ASPECT plane was just one component of a comprehensive air monitoring and sampling network that included several instruments to collect air samples and measure contaminants at and around the site,” the spokesperson said.
“In the first two days, EPA’s air monitoring readings were below detection levels for most contaminants, except for particulate matter. EPA air monitoring did not detect chemical contaminants at levels of concern in the hours following the controlled burn.”
US Capitol Police investigate cocaine discovery at headquarters
The United States Capitol Police (USCP) said they are launching an investigation after a small bag of cocaine was discovered inside its headquarters.
Police found a “roughly one-inch by one-inch zip lock bag with a small amount of a white powdery substance, which field tested positive for cocaine.”
It was found on the floor inside the Capitol Police headquarters, in an area that’s used for a staging spot for furniture and supplies and is “heavily trafficked” by employees and various contractors, USCP said in a release.
The bag was found by an officer just before 1 p.m. Wednesday and was immediately reported to a supervisor.
USCP headquarters is not at the Capitol, but a few blocks away on D Street and Second Street.
USCP said it has opened an investigation into the incident and will conduct further testing, including DNA testing on the bag.
The Hill has reached out for additional comment from USCP, but the release said they will provide more information when it becomes available.
Last July, the Secret Service confirmed that it had found cocaine at the White House. White House press secretary Karine Jean-Pierre said at the time the cocaine was found in a well-traveled area and that West Wing tours took place in the days prior.
President Biden was not at the White House at the time when it was found. The bag was found near where visitors are asked to leave their cellphones on part of the West Wing tour.
'Pelosi says she ‘would never recommend’ Biden debate Trump'
Former Speaker Nancy Pelosi (D-Calif.) said in a Wednesday interview that she “would never recommend” President Biden share the debate stage with former President Trump, shortly after the two agreed to two debates before November’s election.
“I myself would never recommend going on stage with Donald Trump,” Pelosi told CNN’s Manu Raju on Wednesday.
“But the president has decided that’s what he wants to do,” Pelosi said. “I think the format he is suggesting is a good one.”
Biden offered two presidential debates before the election, and Trump accepted the proposal. Trump and Biden will meet in a June 27 debate to be hosted by CNN — a battle that is historically early in the general election calendar — and will meet onstage again Sept. 10 for a debate hosted by ABC.
Many Democrats were pleased to see Biden take on Trump. Sources close to the Biden campaign told The Hill that the debate decision was a strategic move to ensure voters see the difference between the two candidates for themselves before they start to make their decisions.
Pelosi, however, expressed concerns about some of Trump’s past debate behavior – including in 2016, when Trump appeared to physically intimidate Secretary of State Hillary Clinton, the Democratic candidate for president, while on stage. In 2020, Trump interrupted Biden and the moderator more than 100 times, reports said at the time.
Asked why she would not recommend Biden join Trump on the debate stage, Pelosi said, “I think he was stalking Hillary Clinton, he wasn’t professional, he wasn’t presidential, he wasn’t meeting the dignity of the office,” Raju reported.
Pelosi suggested instead that networks hold town hall meetings to let the candidates make their cases to the American public.
“I think you all should have separate town hall meetings with them, and let them, challenge them with questions about the future, and let the public make its decision,” Pelosi said.
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