GW Pharma’s Epidyolex reclassified in UK to lower control level

The UK Home Office has reclassified GW Pharmaceuticals plc’s (NASDAQ:GWPH) Epidyolex (cannabidiol) to Schedule 5 from Schedule 2, a lower level of control that will reduce costs and enable the medicine to be dispensed more easily according to COO Chris Tovey.

The drug is approved in the UK for the adjunctive therapy for seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients at least two years old.

https://seekingalpha.com/news/3585620-gw-pharmas-epidyolex-reclassified-in-uk-to-lower-control-level

BrainStorm to develop NurOwn for Alzheimer’s

BrainStorm Cell Therapeutics (NASDAQ:BCLI) announces that it has established a new clinical development program aimed at using NurOwn to treat Alzheimer’s disease (AD).

It is planning a Phase 2 clinical trial evaluating the autologous cell therapy in patients with prodromal (appearance of initial symptoms)-to-mild AD.

The company is also developing NurOwn for amyotrophic lateral sclerosis (ALS) and progressive multiple sclerosis (MS).

https://seekingalpha.com/news/3585684-brainstorm-to-develop-nurown-for-alzheimers

BriaCell files provisional patent for treatment and diagnosis of COVID-19

BriaCell Therapeutics (OTCQB:BCTXF) has filed a provisional patent application with the USPTO, entitled “MULTI-VALENT DECOY RECEPTORS FOR DIAGNOSIS AND/OR TREATMENT OF CORONAVIRUS INFECTION”.

The application outlines compositions and methods of developing novel multi-valent decoy receptors for diagnosis and treatment of coronavirus infection and seeks protection for the design of new therapeutics and methods for their use.

Multi-valent constructs are believed to have both therapeutic and diagnostic potential.

BriaCell has recently filed three other provisional patent applications related to treatments for coronavirus, including: (1) genetically engineered whole-cell immunotherapy (2) antibody-based treatment; and (3) antigen-based induction of immune response.

https://seekingalpha.com/news/3585637-briacell-files-provisional-patent-for-treatment-and-diagnosis-of-covidminus-19

Merck teams up with Yumanity in neurodegenerative diseases

Merck (NYSE:MRK) inks an agreement with privately held Yumanity Therapeutics for exclusive rights to two of the latter’s pipeline candidates for amyotrophic lateral sclerosis (ALS) and frontotemporal lobar dementia (FTLD).

The parties will also collaborate to advance two preclinical programs, after which MRK will have the right to advance clinical development and commercialization.

Under the terms of the agreement, Yumanity will receive an undisclosed upfront payment, up to ~$500M in milestones and royalties on net sales.

Merck is joining a group of institutional investors in a Series C financing round.

https://seekingalpha.com/news/3585638-merck-teams-up-yumanity-in-neurodegenerative-diseases

Fulcrum to launch late-stage losmapimod trial for COVID-19 patients

The FDA has notified Fulcrum Therapeutics (NASDAQ:FULC) that it may proceed with initiating a Phase 3 trial of losmapimod in higher-risk hospitalized adults with COVID-19.

The Phase 3 LOSVID trial is designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approx. 400 patients.

The primary endpoint is the proportion of patients who progress to death or respiratory failure by day 28.

Top line data are expected in Q1 2021.

An interim analysis will be conducted in Q4 for futility and sample size re-estimation when ~50% of subjects complete the 28-day visit.

Losmapimod is an orally available selective p38α/β mitogen activated protein kinase inhibitor.

https://seekingalpha.com/news/3585642-fulcrum-to-launch-late-stage-losmapimod-trial-for-covidminus-19-patients

Imara’s IMR-687 an Orphan Drug in the U.S. for beta-thalassemia

The FDA has granted Orphan Drug Designation for IMARA’s (NASDAQ:IMRA) IMR-687 for the treatment of patients with beta-thalassemia.

Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.

https://seekingalpha.com/news/3585722-imaras-imrminus-687-orphan-drug-in-u-s-for-beta-thalassemia

Biohaven’s troriluzole flunks obsessive-compulsive disorder study

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) announces results from the Phase 2 proof-of-concept stage of a Phase 2/3 clinical trial evaluating troriluzole in patients with obsessive-compulsive disorder (OCD).

The study failed to achieve the primary endpoint of a statistically significant change from baseline in a scale called Y-BOCS total score at week 12 compared to placebo. Specifically, the change in the treatment arm was -5.9 versus -4.9 in the control arm (p=0.220).

Troriluzole also failed to sufficiently separate from placebo in patients with severe OCD (-7.0 vs. -4.6; p=0.084).

Despite the setback, the company plans to meet with the FDA to discuss the results and clarify the parameters of a pivotal Phase 3 trial assessing two doses of the drug.

Troriluzole, a third-generation prodrug that modulates an excitatory neurotransmitter called glutamate by reducing its levels at nerve synapses, also failed to demonstrate a significant treatment benefit in patients with generalized anxiety disorder.

https://seekingalpha.com/news/3585696-biohavens-troriluzole-flunks-obsessive-compulsive-disorder-study