AUPH Loses Aura, PETX Scores Hat Trick, ACRX Meets Trial Goal

(RTTNews) - AcelRx Pharmaceuticals Inc.'s (ACRX) phase III trial of ARX-04 in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury has met its primary endpoint.

According to the trial results, overall, the 76 adults treated with ARX-04 in the study experienced a mean pain intensity difference to baseline of 2.9 from a baseline of 8.1, on a 0 - 10 numeric rating scale at 60 minutes.

The Department of Defense has asked the company to conduct a cognitive impairment assessment to determine if ARX-04 causes cognitive deficiencies, which is an understandable concern when treating wounded soldiers on the battlefield, said Pamela Palmer, co-founder and chief medical officer of the company.

ACRX closed Monday's trading at $3.67, down 1.61%.

Shares of Aurinia Pharmaceuticals Inc. (AUPH) tumbled over 55% on Monday despite the company's phase IIb study of investigational lupus nephritis drug Voclosporin meeting the trial goals.

The trial, dubbed AURA, achieved its primary endpoint, demonstrating statistically significantly greater complete remission at 24 weeks in patients treated with 23.7 mg of Voclosporin twice daily. However, across the study, there were 13 deaths, which the company said were unrelated to Voclosporin and that there was no dose relationship for the deaths.

Aurinia plans to meet with the FDA in the fourth quarter of 2016 to discuss the data and the drug's subsequent clinical development and path forward. Further analyses of the data will also be conducted and will be released later this year, according to the company.

The AURA study will continue through 48 weeks, and the data will be available for release in early 2017.

AUPH closed Monday's trading at $1.81, down 55.75%.

Pet therapeutics company Aratana Therapeutics Inc.'s (PETX) Nocita has won the regulatory approval for use as a local post-operative analgesia for cranial cruciate ligament surgery in dogs.

The company anticipates Nocita to be commercially available to veterinarians in the fall of 2016.

Nocita is the third product from Aratana's pipeline to receive the green signal. Galliprant for the control of pain and inflammation associated with osteoarthritis in dogs received approval in March of this year while Entyce indicated for appetite stimulation in dogs was approved in May of this year.

Galliprant is expected to be available to veterinarians in fall 2016 while Entyce is expected to be launched in February 2017.

PETX closed Monday's trading at $9.41, down 0.84%. In after hours, the stock was up 3.61% to $9.75.

Axovant Sciences Ltd. (AXON) has 1 clinical catalyst to watch out for in the remainder of this year while there are a number of events lined up for next year.

The company expects preliminary results from its phase II study evaluating Nelotanserin for treatment of visual hallucinations in subjects with Lewy body dementia in the second half of 2016.

For 2017, the company expects results from the following studies:

- Phase III study of Intepirdine in subjects with mild-to-moderate Alzheimer's disease on a stable background of donepezil therapy, dubbed MINDSET Study, as well as a potential NDA filing.

- Phase IIb study of Intepirdine in subjects with dementia with Lewy bodies, the HEADWAY-DLB study.

- Phase II study evaluating Nelotanserin for treatment of REM Behavior Disorder in subjects with dementia with Lewy bodies.

- Phase II study of the effects of Intepirdine on gait and balance in subjects with Alzheimer's disease, dementia with Lewy bodies, and Parkinson's disease dementia.

AXON closed Monday's trading at $15.33, up 1.32%.

AmpliPhi Biosciences Corp. (APHB) is all set to report data from its first phase 1 phage therapy trial of AB-SA01 before the end of the third quarter with the complete study report following later this year.

AB-SA01 is the company's investigational phage therapy targeting Staphylococcus aureus (S. aureus) infections.

APHB closed Monday's trading at $1.89, down 1.23%.

Ritter Pharmaceuticals Inc. (RTTR) has completed patient enrollment in its phase 2b/3 clinical trial of its investigational compound RP-G28 for the treatment of lactose intolerance.

The company expects topline results of the trial to be announced in the first quarter of 2017.

RTTR closed Monday's trading 7.81% higher at $1.38.