TNXP Awaits Data In Q2, LLY Uncovers Ixekizumab's Potential, High Five For MNOV

(RTTNews) - Aimmune Therapeutics Inc.'s (AIMT) phase II follow-on study of AR101 for the treatment of peanut allergy, dubbed ARC002, demonstrated increased desensitization and improved tolerability with low-dose maintenance.

According to the trial results, all patients who completed 12 weeks of low-dose maintenance therapy with AR101 were desensitized to levels of peanut protein beyond the 250-300 mg typically found in one peanut kernel.

The company's phase III trial of AR101 for treatment of peanut allergy, known as PALISADE, is underway. This study is designed to enroll approximately 500 peanut-allergic patients 4-55 years of age at more than 60 clinical sites in the United States, Canada, and nine countries in the European Union.

AIMT closed Friday's trading at $17.70, down 1.01%.

Ardelyx Inc. (ARDX) expects results from its second phase 2b clinical trial of drug candidate Tenapanor for the treatment of hyperphosphatemia in end stage renal disease patients in the second half of 2016.

Tenapanor is also being explored for the treatment of IBS-C (Irritable Bowel Syndrome with Constipation), and results from two phase III clinical trials in that indication are expected in 2017.

ARDX closed Friday's trading at $9.14, down 9.15%.

The FDA has approved CSL Behring's IDELVION for the treatment of hemophilia B. IDELVION becomes the first and only factor IX therapy that delivers high-level protection with up to 14-day dosing in appropriate patients.

Hemophilia B is an inherited sex-linked, blood-clotting disorder, which primarily affects males, and is caused by defects in the Factor IX gene. Hemophilia B affects about 3,300 people in the United States. People with Hemophilia B can experience repeated episodes of potentially serious bleeding, mainly into the joints, which can be destroyed by the bleeding.

IDELVION is the second Factor IX fusion protein product approved in the U.S., and the first being Biogen Idec Inc.'s (BIIB) Alprolix, which was approved in March 2014.

Eli Lilly and Co.'s (LLY) drug candidate Ixekizumab demonstrated clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis as early as one week, compared to patients treated with Etanercept or placebo, according to a combined analysis of phase III trials, dubbed UNCOVER-2 and UNCOVER-3.

The trials, UNCOVER-2 and UNCOVER-3 evaluated more than 2,500 patients with moderate-to-severe plaque psoriasis across 19 countries. In these comparator studies, patients were assigned to receive either placebo, Etanercept (50 mg twice a week) or Ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160-mg starting dose.

According to the trial results, at one week, the mean percentage improvement was 32.7% in the group randomized to receive Ixekizumab every two weeks, 10.3% in Etanercept and 5.31% in placebo.

At two weeks, the mean percentage improvement was 53.6% in the group randomized to receive Ixekizumab every two weeks, 23.3% in Etanercept and 9.25% in placebo.

LLY closed Friday's trading at $73.60, up 0.48%.

MediciNova Inc.'s (MNOV) phase II trial results of MN-166 (ibudilast) in opioid dependence have been encouraging.

According to the trial results, Ibudilast decreased the reinforcing effects of oxycodone and the craving for heroin, cocaine and tobacco significantly. Ibudilast, which was safe and well-tolerated by the participants, also significantly enhanced the analgesic effects of oxycodone.

The company is now considering the next step in the development process to further evaluate Ibudilast's potential utility in the treatment of opioid dependence.

MNOV closed Friday's trading at $5.91, down 0.67%.

Syneron Medical Ltd. (ELOS) and Allergan plc (AGN) have entered into a collaboration to offer three of Syneron Candela's body sculpting and skincare platforms to members of Allergan's healthcare provider loyalty program, Allergan Partner Privileges.

The partnership aims to provide physicians and their patients with comprehensive treatment options for some of the most in demand treatments, including body contouring and skin treatment, according to Syneron.

ELOS closed Friday's trading at $7.37, down 1.07%.

Tonix Pharmaceuticals Holding Corp. (TNXP) has a couple of catalysts up its sleeve to watch out for this year.

The company expects top-line data from its phase II trial of TNX-102 SL for the management of post-traumatic stress disorder (PTSD), a chronic condition, dubbed AtEase, in the second quarter.

A phase III trial of TNX-102 SL for the management of fibromyalgia, dubbed AFFIRM, is underway, and top-line data from this study are expected in the third quarter of 2016.

TNXP closed Friday's trading at $2.41, down 2.23%.