ACST's CaPre Misses Goal Again, AIMT Snapped Up By Nestle, CRMD To Face FDA In Feb, VIR & COVID-19

pharma 050517 01sep20

Today's Daily Dose brings you news about Acasti Pharma's phase III trial of CaPre, Merger Monday, CorMedix's regulatory catalyst, Vanda Pharma's anticipated milestones, and the progress in Vir/Glaxo's COVID-19 trial.

Read on…

1. Acasti Pharma's TRILOGY 2 Study Misses Key Goal

Acasti Pharma Inc.'s (ACST) (ACST.V) phase III study evaluating lead drug candidate CaPre in patients with severe hypertriglyceridemia, dubbed TRILOGY 2, has failed to achieve statistical significance for the primary endpoint.

The primary objective of the TRILOGY 2 study was to determine the efficacy of CaPre 4 g daily compared to placebo in lowering fasting triglyceride (TG) levels in subjects with fasting TG levels more than 500 mg/dL and less than 1500 mg/dL after 12 weeks of treatment.

According to the trial results, CaPre achieved a 30.4% median reduction in triglycerides at 12 weeks and 38.4% at 26 weeks, but did not achieve statistical significance for the primary endpoint.

The company had reported results from its phase III TRILOGY 1 trial in January of this year. The design of the TRILOGY 1 study was also similar to TRILOGY 2.

In the TRILOGY 1 study, CaPre achieved a 30.5% median reduction in triglycerides at 12 weeks and 36.7% at 26 weeks, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks. However, the TRILOGY 1 trial also had not achieved statistical significance.

ACST plunged 65.49% to close Monday's trading at $0.24.

2. Nestle Snaps up the Maker of the World's First Approved Peanut Allergy Treatment

Aimmune Therapeutics Inc. (AIMT) is all set to be acquired by Sociétés des Produits Nestlé S.A, a wholly-owned subsidiary of Nestlé, S.A (NSRGY.OB), for approximately $2.6 billion, or $34.50 per share in cash.

The acquisition adds Aimmune's PALFORZIA, the world's first approved treatment for peanut allergy, to Sociétés des Produits Nestlé's portfolio.

The transaction is expected to close in the fourth quarter of 2020.

AIMT closed Monday's trading at $34.22, up 171.59%.

3. CorMedix to Face FDA in February

CorMedix Inc.'s (CRMD) New Drug Application for Defencath has been accepted for FDA review - with a decision expected on February 28, 2021.

Defencath, an investigational catheter lock solution, is proposed for use in hemodialysis patients for the prevention of catheter related blood stream infections.
Before the regulatory agency's final decision, Defencath is likely to be reviewed by an FDA panel.

CRMD closed Monday's trading at $4.67, down 3.31%.

4. Merger Monday

Ionis Pharmaceuticals Inc. (IONS) has entered into a definitive agreement to acquire the remaining 24% of Akcea Therapeutics Inc. (AKCA) that it does not already own for $18.15 per share in cash. The purchase price corresponds to a total transaction value of approximately $500 million.

The deal helps Ionis realize more financial upside from Akcea's rich pipeline and commercial products besides giving full access to Akcea's significant cash on hand of approximately $390 million as of June 30, 2020. Ionis also expects to achieve meaningful cost synergies.

AKCA closed Monday's trading at $18.28, up 60.63%.

5. Vanda on Track

Vanda Pharmaceuticals Inc. (VNDA) expects to complete enrollment in its phase III study of Tradipitant in gastroparesis in the first half of 2021.

If all goes well as planned, the company is targeting NDA submission of Tradipitant in the second half of 2021.

Gastroparesis, also called delayed gastric emptying, is a condition that delays or prevents the passage of food from the stomach to small intestine, even though there is no blockage in the stomach or intestines. (Source: NIH)

The only FDA approved treatment currently available is metoclopramide, which carries a label restriction of up to 3 months treatment because of increased risk of Parkinson's-like symptoms that can be permanent.

VNDA closed Monday's trading at $10.29, down 0.63%.In after-hours, the stock was down 7.19% at $9.55.

6. Vir/Glaxo Begin Dosing in COVID-19 Trial

Vir Biotechnology Inc. (VIR) and GlaxoSmithKline plc (GSK) have commenced dosing of patients in their phase II/III study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization.

VIR-7831, also known as GSK4182136, is a fully human anti-SARS-CoV-2 monoclonal antibody.

The phase II/III study with VIR-7831, dubbed COMET-ICE, is designed to enroll roughly 1,300 patients worldwide who have early symptomatic COVID-19 infection.

The companies expect initial results from the COMET-ICE trial to be available before the end of this year, with complete results expected in the first quarter of 2021.

VIR closed Monday's trading at $40.48, down 2.79%.

7. Stocks That Moved On No News

Kindred Biosciences Inc. (KIN) closed Monday's trading at $4.96, up 18.38%.

AlloVir Inc. (ALVR) closed Monday's trading at $32.39, up 15.64%.

ProQR Therapeutics N.V. (PRQR) closed Monday's trading at $6.30, up 15.60%.

ADiTx Therapeutics Inc. (ADTX) closed Monday's trading at $3.21, down 17.27%.

SCWorx Corp. (WORX) closed Monday's trading at $1.76, down 14.98%.

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