Today’s Daily Dose brings you news about the fund received by Cyclerion from Alzheimer’s Association, Immunovant’s myasthenia gravis trial meeting key goals, MediWound’s first shipment of NexoBrid to BARDA, Ovid’s ELEKTRA study results and Sarepta’s regulatory catalyst.
1.Cyclerion to Report IW-6463 Data Next Month
Cyclerion Therapeutics Inc. (CYCN) has been awarded $2 million of funding by the Alzheimer’s Association’s Part the Cloud-Gates Partnership Grant Program to support the company’s phase II trial of IW-6463 in Alzheimer’s disease with vascular pathology.
IW-6463 has successfully completed a phase I study and is now being studied in a translational pharmacology study in elderly participants. The top-line data from this study are expected next month.
CYCN closed Tuesday’s trading at $6.71, up 11.09%.
2. Immunovant Ascends to New High
Shares of Immunovant Inc. (IMVT) touched a new high on Tuesday, following positive topline results from its phase IIa study of IMVT-1401 in patients with myasthenia gravis.
Myasthenia gravis is a rare, debilitating, autoimmune disease that causes weakness in the skeletal muscles that worsens after periods of activity and improves after periods of rest. (Source: NIH)
The phase IIa study, dubbed ASCEND MG, involved 15 patients and three arms – 340 mg IMVT-1401 weekly, 680 mg IMVT-1401 weekly, and a placebo arm.
According to the trial results, there was a 3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale and an 8.0-point mean improvement on Myasthenia Gravis Composite (MGC) scale that were statistically significant compared to placebo. The mean reductions in total IgG from baseline for the 340 mg and 680 mg cohorts were 59% and 76%, respectively.
IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs) and no withdrawals due to adverse events, added the company.
The company is expected to initiate a pivotal phase III study of IMVT-1401 in patients with myasthenia gravis in the first half of 2021.
IMVT touched a new high of $37 in intraday trading on Tuesday, before closing at $34.66, up 3.52%. The stock was trading around $17 when we alerted readers to it on March 10, 2020.
Here’s Why Immunovant (IMVT) Merits A Look (https://www.rttnews.com/3076447/here-s-why-immunovant-imvt-merits-a-look.aspx)
3. MediWound Gets a Healing Touch
MediWound Ltd. (MDWD) and its U.S. commercial partner Vericel Corporation (VCEL) have delivered the first shipment of NexoBrid to Biomedical Advanced Research and Development Authority (BARDA).
NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.
The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through the funding of up to $50 million.
A Biologics License Application was submitted to the FDA seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns on June 30, 2020.
MDWD closed Tuesday’s trading at $3.91, up 26.54%.
4. Ovid’s ELEKTRA Not That electrifying in LGS
Takeda Pharmaceutical Company Limited (TAK) and Ovid Therapeutics Inc. (OVID) have reported results from their phase II study of Soticlestat in children with Dravet syndrome or Lennox-Gastaut syndrome.
The study, dubbed ELEKTRA, achieved the primary endpoint, demonstrating a statistically significant reduction of seizures from baseline compared to placebo in the combined Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) study population.
While there was a statistically significant reduction in seizure frequency from baseline in Dravet syndrome cohort treated with Soticlestat compared to placebo, the reductions in seizure frequency in the Lennox-Gastaut syndrome cohort treated with Soticlestat did not achieve statistical significance even though there were numeric reductions in seizure frequency.
Takeda and Ovid plan to initiate a phase III registrational program of Soticlestat in Dravet syndrome.
Ovid is planning to report data from a phase II study of Soticlestat in patients with CDKL5 deficiency disorder and Dup15q syndrome, two other types of highly-refractory DEEs, dubbed ARCADE, later this quarter.
In other news, Ovid announced the pricing of its underwritten offering of 6.25 million shares of its common stock at $8.00 per share. The offering is expected to close on August 27, 2020.
OVID closed Tuesday’s trading at $6.34, down 0.55%.
5. Sarepta to Face FDA in February
Sarepta Therapeutics Inc.’s (SRPT) New Drug Application seeking accelerated approval for Casimersen has been accepted for review by the FDA, with a decision date set for February 25, 2021.
Casimersen, a phosphorodiamidate morpholino oligomer (PMO), is proposed to treat patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.
The FDA has indicated it does not currently plan to hold an advisory committee to review Casimersen and has conditionally accepted the proposed brand name AMONDYS 45.
Sarepta already has two DMD drugs that were given accelerated approval by the FDA – Exondys 51, approved in September 2016, and Vyondys 53, approved in December 2019.
Exondys 51 is indicated for the treatment of DMD in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 51 skipping while Vyondys 53 is indicated to treat DMD patients who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.
SRPT closed Tuesday’s trading at $144.94, up 2.65%.
6. Stocks That Moved On No News
Keros Therapeutics, Inc. (KROS) closed Tuesday’s trading at $62.21, up 28.93%.
Wave Life Sciences Ltd. (WVE) closed Tuesday’s trading at $12.61, up 14.14%.
Edesa Biotech Inc. (EDSA) closed Tuesday’s trading at $6.28, up 12.54%.
Anixa Biosciences Inc. (ANIX) closed Tuesday’s trading at $1.88, down 19.66%.
Sonnet BioTherapeutics Holdings Inc. (SONN) closed Tuesday’s trading at $3.16, down 18.97%.
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