Search This Blog

Friday, April 1, 2022

Dr. Reddy's, MediCane Launch Medical Cannabis Products in Germany

 

  • The launch of medical cannabis products resulted from an agreement between the two companies signed in 2021.

  • Dr. Reddy's will be the exclusive distributor of several of MediCane's medical cannabis products in Germany.

  • Additionally, Dr. Reddy's and MediCane have entered into a collaboration and co-funding arrangement relating to a phase II clinical trial for a medicinal cannabis product aimed at symptom relief of Behavioral and Psychological Symptoms of Dementia (BPSD). When launched, Dr. Reddy's holds exclusive sales and marketing rights for the product in Europe (except Russia and CIS countries).

Sage: Promising Results in Phase 2 Study in Mild Cognitive Impairment, Alzheimer's Dementia

 

  • Data to be Presented During the Emerging Science Session at the American Academy of Neurology’s 74th Annual Meeting
  • The LUMINARY Study is a Phase 2, open-label study evaluating the safety, tolerability and efficacy of SAGE-718 once daily in individuals with mild cognitive impairment and mild dementia due to Alzheimer’s disease
  • SAGE-718 demonstrated improvement across multiple tests of executive performance as well as improvement on key tests of learning and memory in the LUMINARY Study

Human Challenge Study Reveals Potentially Key COVID-19 Data

 U.K. scientists conducting the first human viral challenge on COVID-19 found that symptoms do not have any correlation to a person's ability to infect somebody else.

The landmark Human Challenge Programme, which was conducted by Open Orphan and Imperial College London, deliberately exposed 36 young and healthy participants ages 18 to 30 years old with no immunity to the SARS-CoV-2 virus over the course of 14 days. Once declared infected, they were placed under quarantine with close monitoring by a medical team at a section of London's Royal Free Hospital. This project is the first worldwide to perform detailed tracking over the virus' full course, from the point of infection until the virus is eliminated.

What is notable from the study is that although the participants developed symptoms at a rapid rate, about two days from contact with the virus on average, there appears to be no link between the speed by which a person gets symptoms and how severe the actual viral load. 

"Our study reveals some very interesting clinical insights, particularly around the short incubation period of the virus, extremely high viral shedding from the nose, as well as the utility of lateral flow tests, with potential implications for public health. People in this age group are believed to be major drivers of the pandemic and these studies, which are representative of mild infection," commented Professor Christopher Chiu, the chief investigator of the trial, in a statement

Lateral flow tests confirmed that an infectious virus was present and that the participants were contagious, but this did not demonstrate any relation with the symptoms. Still, LFTs have been proven to be a good predictor of whether or not a person can infect others.

"Even though in the first day or two they may be less sensitive, if you use them correctly and repeatedly, and act on them if they read positive, this will have a major impact on interrupting viral spread," Chiu added.

Of the 36 healthy volunteers that started with the trial, 18 had become infected, while 16 developed mild-to-moderate symptoms similar to a cold. None of them developed any serious symptoms, although two had later been excluded from the study after they were found to be developing antibodies from the time of initial screening to inoculation. Thirteen of those who were infected had temporarily lost their sense of smell, but this resolved itself within 90 days. All participants will be followed up for 12 months after exiting the facility to note if there are any effects in the long term.

The researchers are hoping to expand the study to include more participants to truly reflect on the greater population. Despite the limitations, however, industry experts see the findings as a good driver for public health initiatives, including isolation periods for those infected, proper wearing of face masks, using LFTs, and developing a broader and more targeted human challenge platform look into COVID-19 from various perspectives.

"While the characterization study was focused on the original SARS-CoV-2 strain, and there are differences in transmissibility between it and the other variants, the same factors will be responsible for protection against it, meaning the findings remain valuable for variants such as Delta or Omicron. These data provide a clear platform to now utilize the human challenge model to expedite product efficacy testing for new vaccines or antivirals," commented Dr. Andrew Catchpole, the chief scientific officer at hVIVO, a unit of Open Orphan, in the same release.

https://www.biospace.com/article/covid-19-symptoms-not-connected-to-viral-load-but-lfts-may-offer-more-clarity-uk-scientists/

Phase III Results Set Neurocrine Up for Huntington's Chorea sNDA

 Neurocrine Biosciences announced positive results Friday from its Phase III KINECT-HD study evaluating the efficacy of valbenazine in the treatment of chorea associated with Huntington's Disease (HD). The data is slated to be presented on April 5th, 2022, during the Emerging Science Session at the American Academy of Neurology 2022 annual meeting.

Huntington's Disease is a fatal, genetic brain disease caused by a DNA error in a gene called huntingtin. Huntingtin protein is very large and has many functions, but the DNA error in people with HD causes the protein to aggregate in protein clumps in brain cells which cause them to become damaged and die. As HD progresses, symptoms can include personality changes, forgetfulness, unsteady gait, involuntary movements and difficulty swallowing.

Uncontrolled and involuntary movements are also known as chorea, a hallmark symptom of HD due to excessive damage to the part of the brain known as the striatum, which is especially vulnerable in Huntington's patients. Chorea causes patients to lose weight and have difficulty walking and moving around safely, which leads to a need for around-the-clock care as the disease worsens. 

It is estimated that there are 41,000 Americans with symptomatic HD and another 200,000 who are at-risk of inheriting the disease.

There are currently no approved treatments to prevent the disease's progression, but Neurocrine aims to make a difference by providing treatment that targets chorea. The KINECT-HD evaluated the use of valbenazine in 128 adults with motor manifest HD. Valbenazine was taken once daily and met its primary endpoint of change in chorea severity and was significantly more effective at improving chorea severity than placebo.       

Treatment with valbenazine also met secondary endpoints of improvement on clinician assessment of how much patients' illness improved with treatment as well as patient assessment of improvement. The drug also provided improvements in symptoms of chorea as early as week two of treatment, with an upward trend of continued improvement as the trial continued.          

Adverse events reported during the trial were reported to be mild to moderate and consistent with the known safety profile for valbenazine. Side effects included fatigue, fall, excessive sleepiness and akathisia or restlessness.       

Valbenazine is a drug used to treat tardive dyskinesia, a disorder that affects the nervous system and causes repetitive, involuntary muscle movements in the face, neck, arms and legs. It is a vesicular monoamine transporter 2 (VMAT2) inhibitor that changes the activity of certain neural substances in the brain by depleting neuroactive peptides, such as dopamine, at nerve terminals. Depletion of these substances can help decrease spontaneous motor movements associated with chorea and other degenerative neurological conditions.           

"Presentation of these positive data of valbenazine for chorea in Huntington's disease represent a major step forward in our commitment to offering the community a potential new treatment option," said Eiry W. Roberts, M.D., chief medical officer at Neurocrine Biosciences. "We are proud to work with the Huntington Study Group and the Clinical Trials Coordination Center at the University of Rochester on this program. Data from the KINECT-HD and the ongoing KINECT-HD2 study will form the basis of our supplemental new drug application (sNDA) for submission to the U.S. Food and Drug Administration later this year."          

KINECT-HD2 is an open-label Phase III study intended to evaluate the long-term safety and tolerability in the treatment of chorea in HD patients. Neurocrine plans to enroll 150 patients in a 112-week study to collect longitudinal data.

https://www.biospace.com/article/neurocrine-presents-positive-data-for-treatment-targeting-chorea-associated-with-huntington-s-disease/

Clovis equity investors overlook two elephants

 Is Clovis saved? Judging by its stock price, at times up nearly 60% yesterday on the back of a positive readout of the Rubraca label-extension study Athena, you might think that all its previous troubles and missteps were behind it.

Unfortunately – for equity investors, at least – this is wide of the mark. It cannot be denied that the Athena result is highly promising, but Clovis comes late to the game here, and faces entrenched rival drugs from Astrazeneca/Merck & Co and Glaxosmithkline; moreover, its horrific capital structure means that it is effectively beholden to its debt holders.

Clovis is still heavily net loss-generating ($265m last year), and its balance sheet features $472m of net debt. Repaying its gross debt pile of $615m would require the raising of well over $700m in equity – a figure over twice as high as the company’s market cap, which stood at $287m even after yesterday’s stock closed up 22%.

Rubraca sales so far have disappointed. The drug is approved for late-line ovarian cancer maintenance, but this and two other uses have made it a distant follower to Astra/Merck’s Lynparza and another Parp inhibitor, Glaxo’s Zejula.

Highly competitive

In isolation, though, Athena suggests Rubraca to be a highly competitive Parp inhibitor. The trial tested it against placebo in front-line ovarian cancer maintenance, and on a cross-study basis the data seem to put it at least on a par with Lynparza and Zejula, Clovis revealed yesterday.

Most importantly for the group, Rubraca in this setting has scored in all-comers, and its progression-free survival benefit appears to be stronger than Zejula in the corresponding Prima trial. Only Zejula carries an all-comers label in front-line ovarian cancer maintenance.

Lynparza, meanwhile, is approved in first-line ovarian cancer maintenance, but only in genetically defined groups: BRCA-mutant disease as monotherapy, and in HRD-positive patients in combination with Avastin. Subgroup readouts from Athena also confirmed Rubraca to be active in these groups, which clearly drive the all-comers benefit, though importantly an HRD-negative cut also appears positive.

Cross-trial comparison of median PFS in 1st-line ovarian cancer maintenance
 All-comersBRCA-mutantHRD-positive
Rubraca20.2 vs 9.2 mthNR vs 14.7 mth28.7 vs 11.3 mth
HR=0.52 (p<0.0001)HR=0.40 (p=0.0041)HR=0.47 (p=0.0004)
TrialAthena
 
LynparzaNR vs 13.8 mth37.2 vs 17.7 mth
HR=0.30 (p<0.0001)HR=0.33
TrialSolo-1Paola-1*
 
Zejula13.8 vs 8.2 mth
HR=0.62 (p<0.0001)
TrialPrima
Note: *Avastin combo; NR=not reached. Source: company info & product labels.

Damningly, however, in a mid-2021 note to clients Leerink analysts wrote: “Rubraca has been a distant follower ... and risks becoming increasingly clinically irrelevant. We do not view the Athena trial, even if positive, as likely to tip the scale enough for Rubraca to gain traction in the first-line setting versus Lynparza and Zejula.”

Those who believe that good data will always win out in the end will hope that Clovis might be taken over by a big pharma partner with the necessary muscle to hit Rubraca’s two entrenched rivals. However, equity holders clinging to this view overlook Clovis’s ongoing financial woes, about which Evaluate Vantage has been cautioning for some time.

Given Clovis's huge gearing relative to market cap, the group's value resides mostly in its debt. A smart acquirer could simply buy the company’s debt; the equity value is destined to dwindle away as debt repayment or a crippling debt-for-equity swap loom.

https://www.evaluate.com/vantage/articles/news/trial-results/clovis-equity-investors-overlook-two-elephants

Walgreens cut to Neutral from Outperform by Baird

 Target to $51 from $70

https://finviz.com/quote.ashx?t=WBA&ty=c&ta=1&p=d

Spero update on FDA review of NDA

 The U.S. Food and Drug Administration (FDA) has notified Spero that, as part of its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review. Spero intends to work with the FDA to seek to resolve the deficiencies expeditiously.

The FDA previously assigned a Prescription Drug User Fee Act (PDUFA) goal action date of June 27, 2022, for completion of its review of the NDA, and initially targeted the midpoint of that review period to communicate proposed labeling and, if necessary, any post-marketing requirement and/or commitment requests to Spero. The Company noted that there are three months remaining before the PDUFA goal action date. Spero also has a late cycle review meeting scheduled with the FDA and expects to provide an update on or before its next earnings call in May 2022.

https://www.globenewswire.com/news-release/2022/03/31/2414340/0/en/Spero-Therapeutics-Announces-Fourth-Quarter-and-Full-Year-2021-Operating-Results-and-Provides-Business-Update.html