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Tuesday, October 6, 2020

Akari Therapeutics (AKTX -1.6%) announces further progress in its COVID-19 pneumonia program with nomacopan in the U.S. and Brazil.
Nomacopan’s dual complement and leukotriene inhibition has applicability in a range of other severe lung inflammatory conditions
COVID-19 pneumonia is believed to be a major cause of death in patients with COVID-19 and despite improvements in standard of care, remains difficult to treat.
Both studies in the U.S. and Brazil are double blind randomized clinical studies of over 60 patients each, with a primary endpoint of time to oxygen normalization and hospital discharge.
Press Release
https://seekingalpha.com/news/3620183-akari-therapeutics-furthers-clinal-trials-for-covidminus-19-pneumonia

Santhera Pharmaceuticals (OTCPK:SPHDF -28.8%) has stopped a Phase 3 trial of Duchenne muscular dystrophy (DMD) drug Puldysa (idebenone) after data from an interim analysis concluded the study was unlikely to meet its primary endpoint.
The setback prompted the company to withdraw the European marketing authorization application and end the global development program for Puldysa.
The interim analysis was based on the primary endpoint of the study, the change of forced vital capacity % predicted (FVC%p) from baseline to 18 months of treatment. The outcome revealed that the probability of reaching the primary endpoint at the end of the study is too small to merit the continuation of the study.
Last year, Santhera refiled for European Medicines Agency approval of idebenone. The application followed an earlier, drawn-out effort to get idebenone to market in DMD that ended with an EMA rejection in 2017 and a failed appeal early the following year.
Now the company will be focused on vamorolone, nonhormonal steroid modulator in DMD and lonodelestat in lung diseases such as cystic fibrosis. Vamorolone is in a Phase 3 trial with top-line data in Q2 of 2021. Lonodelestat is in Phase 1b in cystic fibrosis.
Santhera will continue preclinical work on its gene therapy project.
https://seekingalpha.com/news/3620187-santheras-puldysa-flunks-late-stage-dmd-study-withdraws-european-approval-application

Molecular Partners (OTCPK:MLLCF +3.9%) has announced supportive preclinical data from in vivo assessments of its DARPin candidates targeting SARS-CoV-2.
In the five-day experiment, all animals treated with DARPin molecules (MP0420 or MP0423) recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression.
"The clinical efficacy observed in both prophylactic and post exposure settings, especially in the context of the severity of disease displayed by our novel COVID-19 model, holds promise for this class of virus-neutralizing inhibitors in later line settings," said Jakob Trimpert, lead investigator of the study.
First-in-human studies for MP0420 are anticipated to begin in November, and clinical studies for the second antiviral candidate, MP0423, are expected to initiate in H1 2021.
https://seekingalpha.com/news/3620204-molecular-partnerss-darpin-molecules-show-encouraging-preclinical-action-against-covidminus

The independent Institutional Review Board has granted approval to AIM ImmunoTech (AIM +3.8%) to widen the trial for its drug candidate Ampligen and include people suffering from long-term effects of the coronavirus (COVID-19).
The group, known as COVID-19 ‘long haulers’ as they continue to show chronic fatigue-like symptoms for months after officially recovering from their initial illness, will be included in the clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Up to 20 of the 100 active participants can be long haulers, according to the new trial protocol amendment, and the firm is now preparing the IRB-approved protocol for submission to the FDA.
In June, the company filed a provisional utility patent application for Ampligen to be used as a possible treatment for chronic fatigue associated with COVID-19.
https://seekingalpha.com/news/3620182-aim-immunotech-to-recruit-long-term-covidminus-19-patients-chronic-fatigue-in-ampligen-trial

Novartis (NVS -1.4%) has in-licensed exclusive global rights to a Phase 2-ready program in osteoarthritis, M6495, from Merck KGaA (OTCPK:MKGAY).
The candidate, an anti-ADAMTS5 (a disintegrin and metalloproteinase with thrombospondin motifs 5) Nanobody, was originally jointly developed by Merck KGaA and Ablynx under a 2011 agreement then solely developed by Merck after Sanofi acquired Ablynx in June 2018.
Under the terms of the deal, Merck will receive €50M upfront, up to €400M in milestones and royalties on net sales.
The disintegration of aggrecan, an essential component of joint cartilage, by ADAMTS5 is believed to be an early event of cartilage breakdown.
https://seekingalpha.com/news/3620223-novartis-nabs-osteoarthritis-candidate-from-germanys-merck

Herbalife Nutrition (HLF -0.1%) launches MemoryArmor supplement, to support mental attention, auditory learning, and short-term working memory, and focus.
MemoryArmor features 300 mg of pure Bacopa extract, a plant that has been used in traditional Indian practice for centuries to support brain function.
The company statements are not evaluated by FDA.
https://seekingalpha.com/news/3620244-herbalife-nutrition-launches-supplement-for-short-term-memory-and

Despite earlier opposition to the FDA's approach to evaluating the safety of widespread deployment of COVID-19 vaccines, if approved, the Trump administration has how endorsed the agency's plans.
Although remote beforehand, the White House's support of the guidelines practically eliminates the possibility of an FDA nod before election day since they include a two-month post-vaccination observation period to ascertain any negative side effects.
https://seekingalpha.com/news/3620249-white-house-on-board-fda-guidelines-for-vetting-covidminus-19-vaccines

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