Today’s Daily Dose brings you news about another Alzheimer’s disease drug failure, encouraging data of Aclaris’ rheumatoid arthritis trial; Royalty Pharma/Minerva deal; Gritstone joining the COVID-19 vaccine race; and FDA imposing a clinical hold on Histogen’s planned trial of HST-003 for knee cartilage regeneration.
1. Aclaris Soars on Rheumatoid Arthritis Trial Results
Shares of Aclaris Therapeutics Inc. (ACRS) soared more than 220% on Tuesday, following positive preliminary topline results from a 12-week, phase IIa clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
The trial involved 19 subjects who were randomized to receive either ATI-450 at 50 mg twice daily or placebo, in combination with Methotrexate, for 12 weeks.
According to the trial results, ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and evaluation of ACR20/50/70 responses over 12 weeks.
DAS28-CRP refers to Disease Activity Score measured using C reactive protein in the blood. In the trial, the mean change from baseline in DAS28-CRP score at week 12 was a 2.0 reduction in the treatment arm compared to a 0.35 increase in the placebo arm.
Now that the phase IIa trial has produced encouraging results, ATI-450 is expected to advance to phase IIb stage.
In other news, the company announced that it intends to sell shares of its common stock in an underwritten public offering.
ACRS closed Tuesday’s trading at $18.83, up 220.24%.
2. Another epitaph in the graveyard of Alzheimer’s drugs?
Another potential Alzheimer’s drug has failed – and this time, it is Biohaven Pharmaceutical Holding Co. Ltd.’s (BHVN) Troriluzole.
In a phase II/III trial in mild-to-moderate Alzheimer’s disease, Troriluzole did not statistically differentiate from placebo at 48 weeks on the study’s prespecified co-primary endpoints on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).
Full study results, including additional secondary and exploratory outcomes, biomarker, and subgroup analyses, are expected in the coming months and will be presented at an upcoming scientific meeting, noted the company.
A high failure rate has marred the progress of Alzheimer’s medications. A U.S. study that examined how Alzheimer’s clinical trials fared during period from 2002 to 2012, showed a 99.6 percent failure rate compared to an 81 percent failure rate for cancer drugs.
BHVN closed Tuesday’s trading at $77.83, down 8.34%.
3. Gritstone Joins Coronavirus Vaccine Race
Shares of Gritstone Oncology Inc. (GRTS) jumped nearly 249% on Tuesday, on news of the company deciding to advance its second generation COVID-19 vaccine program, dubbed CORAL.
The second generation COVID-19 vaccine, which is said to offer potential protection against spike mutants, is under preclinical program. The Bill & Melinda Gates Foundation (Gates Foundation) is supporting the preclinical evaluation of the vaccine.
The CORAL program includes two vaccine candidates – Spike-based (S) and Spike + T cell Epitopes (S-TCE). According to the company, the S-based vaccine will allow faster dose evaluation and immunogenicity comparison with S-TCE.
Gritstone will be conducting a Phase 1 clinical trial through the NIAID-supported Infectious Diseases Clinical Research Consortium, with preliminary data expected in mid-2021.
GRTS closed Tuesday’s trading at $22.27, up 248.51%. In after-hours, the stock was up another 18% at $26.30.
4. FDA Slaps Clinical Hold on Histogen’s planned HST-003 Trial
Shares of Histogen Inc. (HSTO) plunged 16% in after-hours Tuesday, on news of the FDA imposing a clinical hold on the company’s planned phase I/II clinical trial of HST-003 for knee cartilage regeneration.
The clinical hold, which has been verbally notified, is due to pending CMC (Chemistry, Manufacturing, and Control) information that is required by the FDA to complete the review of the company’s Investigational New Drug application.
Histogen said that it plans to work diligently with the FDA to seek the release of the clinical hold and provide updated guidance on any potential impact to the HST-003 program once the written notice from FDA is received.
HSTO closed Tuesday’s trading at $1.18, up 15.69%. In after-hours, the stock was down 16.64% at $0.98.
5. Minerva Gains On Royalty deal
Royalty Pharma plc (RPRX) is all set to acquire Minerva Neurosciences Inc.’s (NERV) royalty interest in Seltorexant for an upfront payment of $60 million and up to $95 million in additional milestone payments.
In 2017, under an amended agreement with Janssen Pharma, a subsidiary of Johnson & Johnson (JNJ), Minerva regained global strategic control over development of Seltorexant for insomnia with Janssen foregoing its right to royalties on Seltorexant insomnia sales in European Union, Switzerland, Liechtenstein, Iceland, and Norway.
A phase III trial of Seltorexant for the treatment of major depressive disorder (MDD) with insomnia symptoms is being conducted by Janssen Pharma. Minerva Neurosciences is entitled to a mid-single digit royalty on worldwide net sales of Seltorexant.
Commenting on the agreement with Royalty Pharma, Minerva said that the proceeds will be used to fund continued development of Roluperidone, its proprietary lead compound, which is in phase III development to treat negative symptoms in schizophrenia.
NERV closed Tuesday’s trading at $3.45, up 27.31%.
6. Stocks That Gained/Lost the Most
Senseonics Holdings Inc. (SENS) closed Tuesday’s trading at $2.85, up 80.38%.
TransEnterix Inc. (TRXC) closed at $3.49, up 68.60%.
ENDRA Life Sciences Inc. (NDRA) closed at $1.74, up 65.71%.
ProPhase Labs Inc. (PRPH) closed at $11.93, down 25.44%.
CollPlant Biotechnologies Ltd. (CLGN) closed at $13.50, down 14.34%.
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