|Anacor Shares Surge To All-Time Highs After Phase 3 Trials Of Eczema Drug; Ohr Pharma Announces Positive Results of a Phase II Clinical Study for OHR-102|
|By Marilyn Mullen|
|Monday, 13 July 2015 21:35|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 13, 2015.
Anacor Pharmaceuticals Inc. (NASDAQ: ANAC) executives announced the results of two Phase 3 trials for a topical drug to treat atopic dermatitis, more commonly known as eczema. The treatment came in the form of a topical ointment, crisaborole.
Atopic dermatitis compromises the skin's ability to hold moisture, causing dryness, itchiness and irritability. Those afflicted typically have family histories of other allergies.
The Research -- The studies were each double-blind, conducted at multiple centers throughout the United States and involved at least 750 patients. Those involved had mild to moderate eczema that afflicted at least 5 percent of their bodies. The researchers defined primary success as "clear" or "almost clear" skin with at least a two-grade improvement over the baseline at Day 29. Secondary success was identified as "clear" or "almost clear" skin regardless of improvement.
Related Link: Wedbush On Anacor Pharma: Crisaborole Delivers -- In the first trial, 33 percent of patients experienced primary success taking crisaborole versus only 25.4 percent who took a vehicle; 52 percent saw secondary improvement, with only 40 percent of vehicle-users recording such progress. In the second trial, although the percentage who saw success with a vehicle was substantially smaller, only slightly fewer people experienced success with crisaborole.
According to Anacor execs, there were no instances of serious adverse effects among patients, although there were some mild ones. Side effects included application site pain and upper respiratory tract infection. The percentage of participants who had to discontinue their crisaborole regimen due to adverse effects was the same as the percentage taking the vehicle who cut themselves off.
A Large Market Opportunity -- Anacor leadership was very optimistic about the opportunity in the treatment of atopic dermatitis. They noted that the condition affects between 18 and 25 million people across the United States, with the vast majority of conditions being mild or moderate – within crisaborole's treatment capabilities.
Anacor researchers found that all current eczema treatments either lack satisfactory safety or sufficient efficacy. Safety issues can be especially concerning, since about 85 percent of cases first manifest below the age of five.
Moreover, the market dynamics are very favorable, Anacor representatives stated. The execs first highlighted the tight, 35,000 person subscriber base, composed of dermatologists, pediatricians and some primary care physicians. The also said that "current topical [pharmacological] prescriptions enjoy broad market access."
Anacor executives were confident that crisaborole would be well-positioned to take advantage of the opportunity before it. Already in late-stage testing, they don't foresee any branded competitors at the time of launch.
The plan to submit a New Drug Application to the U.S. FDA sometime during the first half of 2016.
Investors were thrilled by the presentation, with Anacor stock trading up about 50 percent Monday. The company's shares surged to all-time highs soon after the conference call.
Ohr Pharmaceutical, Inc. (NASDAQ: OHRP), an ophthalmology research and development company, announced positive final results from a Phase II investigator sponsored clinical trial of OHR-102 (0.2% Squalamine lactate ophthalmic solution) in patients with macular edema secondary to branch (BRVO) and central retinal vein occlusion (CRVO). The results demonstrated that, following an initial 10 week combination therapy treatment period, patients who continued to receive a combination of topical OHR-102 BID plus Lucentis® achieved greater visual acuity gains than the control group who received Lucentis alone. At week 38, the mean gain in visual acuity from baseline for patients randomized (at week 10) to treatment with OHR-102 + Lucentis PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis plus PRN alone (control group), a clinically meaningful difference of +4.5 letters. The data were presented by John Wroblewski, MD, a retina specialist at Cumberland Valley Retina Consultants on Saturday, July 11 at the 2015 Annual Meeting of the American Society of Retina Specialists (ASRS) in Vienna, Austria.
"These very promising final results demonstrate a clinically meaningful treatment effect of OHR-102 combination therapy for the treatment of macular edema secondary to retinal vein occlusion," said John Wroblewski, MD, principal investigator of this Phase II study. "The 38 week data confirm a positive and meaningful effect on both visual acuity and macular edema. Importantly, continued treatment with OHR-102 combination therapy for the full 38 weeks of the study resulted in further improvements in visual gains over those patients that only received combination therapy for the first 10 weeks of the study."
This investigator-sponsored trial was designed to determine the effect of OHR-102 in eyes with macular edema secondary to retinal vein occlusion. The data presented at ASRS included the final analysis of patients that, following a 10 week initial combination treatment period, were randomized to receive either continued OHR-102 + Lucentis PRN therapy or only Lucentis monotherapy PRN through week 38. After the initial combination therapy phase, the mean gain in visual acuity from week 10 to week 38 was +7.4 letters for patients who continued treatment with OHR-102 + Lucentis PRN compared with +3.1 letters in those receiving Lucentis PRN alone. Furthermore, at week 38, 80% of patients in the OHR-102 + Lucentis treated group had a gain in visual acuity, compared with 50% of patients treated with Lucentis alone. Additionally, at week 38, none of the patients in the OHR-102 + Lucentis treated group lost any vision. Patients treated with OHR-102 + Lucentis PRN required a mean of 2.0 Lucentis injections between weeks 10 and 38, compared with a mean of 3.3 Lucentis injections for the monotherapy group over the same time period.
"The positive results of this Phase II study demonstrates the role of OHR-102 combination therapy in RVO and represent an important milestone for the development of OHR-102 in the treatment of this disease," said Dr. Jason Slakter, Chief Medical Officer of Ohr. "This trial constitutes the second clinical study in a retinal vascular disorder which has shown a positive and clinically meaningful benefit in visual acuity using OHR-102 combination therapy versus an intravitreal anti-VEGF injection alone. The consistency of the efficacy data in this study, combined with the favorable safety profile of OHR-102, we believe warrants further study in a large controlled clinical trial."
Study Design -- The 38 week, investigator sponsored, Phase II clinical trial enrolled 20 treatment naïve patients with macular edema due to retinal vein occlusion. All patients received OHR-102 topically for the first 10 weeks of treatment, with two injections of Lucentis given at week 2 and week 6. The week 10 results were presented at ASRS 2014, and demonstrated that the combination of topical OHR-102 eye drops and intravitreal Lucentis led to a mean gain in visual acuity of 20.3 letters and resolution of the foveal edema in 95% of the patients. In the extension stage of the study (weeks 10 to 38), patients were randomized 1:1 at week 10 to either continue administering OHR-102 eye drops or discontinue drops for the remainder of the study. Retreatment with Lucentis injections were administered monthly as needed (PRN) through week 38 based on OCT criteria.
Acasti Pharma Inc. (NASDAQ:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces its results for the first quarter ended May 31, 2015.
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has received approval to commence trading on the OTCQX® Best Marketplace (OTCQX) at market open today, July 13, 2015, under its existing ticker symbol, "AMBS."
ChromaDex Corp. (OTCQX:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products announced today that Rob Fried has joined the Company's Board of Directors as an Independent Director.
CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the appointment of Marvin L. White to its Board of Directors and as Chairman of the Audit Committee. CoLucid's Board now stands at seven directors, six of whom are independent.
EXL (NASDAQ:EXLS), a leading business process solutions company, today announced that it has received a special award for its Analytics solution on 'Preventive Hospitalization' at the NASSCOM Big Data & Analytics Summit in Hyderabad on June 25, 2015.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that the company has initiated patient dosing in its Phase 1/2 clinical trial of FPA008, a CSF1 receptor antibody, in pigmented villonodular synovitis (PVNS).
Fluidigm Corporation (NASDAQ:FLDM) and OpGen, Inc. (NASDAQ:OPGN) today announced an expanded relationship and new agreement that includes collaborating on the development of test kits and custom analytic instruments for identification, screening, and surveillance testing of multi-drug resistance organism (MDRO) genes of pathogens, such as bacteria, fungi and viruses.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 49 new employees.
IRADIMED CORPORATION (NASDAQ:IRMD) announced today that the Company will release its 2015 second quarter financial results before the market opens on Thursday, July 30th.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the closing of the previously announced offering of shares of its common stock, which included 750,000 shares offered by the Company and 3,750,000 shares offered by the selling stockholders named in the registration statement (the "selling stockholders"), at a price to the public of $22.60 per share.
Pacific Biosciences of California, Inc. (NASDAQ:PACB) will hold its quarterly conference call to discuss its Second Quarter 2015 Financial Results on Wednesday, August 5, 2015, at 4:30pm Eastern Time.
A number of new scientific publications demonstrate the growing momentum for using Single Molecule, Real-Time (SMRT®) Sequencing to capture genetic variants that other technologies miss, according to Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II Sequencing System.
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the publication of the PRIME study results in Kidney International.
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, today announced the publication of preclinical data on the disease-modifying potential of utrophin modulation in the treatment of DMD.
Tumbleweed Holdings, Inc. (OTC:DCDC), a leader in the emerging cannabis information economy, has signed a letter of intent to acquire the GrasshopperSM retail loyalty platform, expanding Tumbleweed's commitment to delivering a robust suite of information technologies.
UBIC, Inc. (Nasdaq:UBIC) (TSE:2158), a leading provider of artificial intelligence (AI)-based big data analysis services, together with UBIC MEDICAL, Inc., a wholly-owned subsidiary of UBIC that provides AI-based medical data analysis solution services, will participate in the International Modern Hospital Show 2015, which will be held at the Tokyo Big Sight from July 15 to 17, marking the Company's first time to participate in this event.
Vital Images, Inc. (Vital) will debut its 510(k) FDA-cleared CT Myocardial Perfusion application at the 10th Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT) in Las Vegas, July 16-19.
Zosano Pharma Corporation (NASDAQ:ZSAN) announced today important leadership additions with the hiring of Donald Kellerman, Pharm.D. as Vice President, Clinical Development; David Zhang, Ph.D. as Executive Director, Biostatistics and Data Management; and Jacquie Mardell as Senior Director, Clinical Operations.