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AZN's COVID-19 Vaccine Shows Strong Responses, ACAD Fails CLARITY Study, BTAI Hits New High

biotech july21 lt

Today's Daily Dose brings you news about disappointing results from ACADIA's major depressive disorder drug trial, AstraZeneca's promising results of COVID-19 vaccine candidate, BioXcel Therapeutics' SERENITY program, Immuron's update on its new therapeutic against campylobacter and ETEC (E-Coli) and very encouraging results of Synairgen's SNG001 in hospitalized COVID-19 patients.

Read on…

1. ACADIA Fails CLARITY Study

Shares of ACADIA Pharmaceuticals Inc. (ACAD) fell more than 12% to $48.57 in after-hours on Monday, following disappointing results from a phase III program of Pimavanserin, dubbed CLARITY.

The 298-patient phase III CLARITY study is a combination of two identical, double-blind, placebo-controlled studies known as CLARITY-2 and CLARITY-3, which evaluated Pimavanserin as an adjunctive treatment for major depressive disorder (MDD).

According to the Company, the CLARITY study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week 5. Pimavanserin 34 mg, given once-daily as an adjunctive treatment to standard antidepressant therapy was associated with a mean reduction of 9.0 in HAMD-17 total score compared to 8.1 for placebo as an adjunctive treatment.

Pimavanserin is approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis in the U.S. and has been marketed under the trade name NUPLAZID since 2016.

In other news, the Company announced that the FDA has accepted for review, the supplemental New Drug Application for NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis, with a decision date set for April 3, 2021.

ACAD closed Monday's trading at $55.42, up 0.82%. In after-hours, the stock was down 12.36% at $48.57.

2. AstraZeneca's COVID-19 Vaccine Shows Strong Antibody, T-cell Responses

AstraZeneca PLC's (AZN) ongoing phase I/II trial of COVID-19 vaccine candidate AZD1222, dubbed COV001, has yielded positive interim results, showing strong antibody and T-cell responses.

The COV001 trial has enrolled up to 1,077 healthy adults, aged 18-55, in five trial centers in the UK.

In the COV001 trial, a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Neutralizing activity against SARS-CoV-2 was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose, according to the results published in The Lancet.

Rapid induction of antibodies and T-cells against the SARS-CoV-2 virus may be important in protection against COVID-19. The level of neutralizing antibodies is a measure of a vaccine's efficacy.

The phase II/III trials of AZD1222 are currently underway in the UK, Brazil, and South Africa and are due to start in the US.

The Company has a deal in place with R-Pharm, a Russian pharmaceutical company, for the manufacturing of AZD1222 in Russia.

AZN touched a new high of $64.94 in intraday trading on Monday, before closing at $58.68, down 3.96%.

3. BioXcel Hits All-time High On SERENITY Data

BioXcel Therapeutics Inc.'s (BTAI) phase III program of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder has met the primary and secondary endpoints, demonstrating a robust treatment effect in the trials.

The phase III program consists of two trials - SERENITY I evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and SERENITY II evaluating BXCL501 for bipolar disorder.

The results of both the studies demonstrated that BXCL501 was well tolerated, with rapid and durable reductions in agitation.

The Company is planning NDA submission of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder in the U.S. in the first quarter of 2021.

BTAI touched an all-time high of $71.50 in intraday trading on Monday, before closing at $60.42, up 14.02%.

4. Immuron Soars on Update Related To campylobacteriosis/ETEC Trial

Shares of Immuron Limited (IMRN) rose as much as over 200 percent to $19.53 in intraday trading, following an update related to the Pre-IND meeting with FDA regarding a new therapeutic against campylobacter and ETEC (E-Coli).

The new therapeutic is being developed by the US DoD Naval Medical Research Center in collaboration with Immuron. Last month, the Naval Medical Research Center had requested a meeting with the FDA for guidance on two phase II trials of the new therapeutic to prevent acute infectious diarrhea.

The U.S. regulatory agency has now provided written guidance in relation to the clinical development pathway of the new investigational drug targeting moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections.

Following the FDA's guidance and feedback, the NMRC plans to file an investigational new drug application later this year and commence two phase II trials of the new therapeutic, a Hyper-immune product, in 2021. One trial will focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis and the second trial will focus on ETEC infections.

IMRN closed Monday's trading at $10.41, up 63.42%.

5. Synairgen's SNG001 Reduces Risk of Developing Severe COVID-19 Disease By 79%

Shares of UK-based Synairgen plc (SNG.L) jumped as much as 550 percent on Monday, following positive results from its clinical trial of SNG001 in hospitalized COVID-19 patients.

The trial enrolled 101 patients from 9 specialist hospital sites in the UK during the period March 30 to May 27, 2020.

According to the trial results, in patients receiving SNG001, the odds of developing the severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% compared to patients who received placebo.

Over the treatment period, patients who received SNG001 were more than twice as likely to recover as those receiving placebo and the measure of breathlessness was markedly reduced in them.

While there were no deaths among patients treated with SNG001, the placebo group reported three deaths.

SNG.L closed Monday's trading at 190 GBP, up 420.55%.

6. Stocks That Moved On No News

Tonix Pharmaceuticals Holding Corp. (TNXP) closed Monday's trading at $1.55, up 91.36%.

iBio Inc. (IBIO) closed Monday's trading at $6.41, up 63.94%.

Heat Biologics Inc. (HTBX) closed Monday's trading at $3.62, up 47.15%.

Genetic Technologies Limited (GENE) closed Monday's trading at $4.31, down 23.99%.

I-Mab (IMAB) closed Monday's trading at $28.55, down 13.46%.

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