Our New Pick is: OHRP
Alert Price: $0.74
Float: 32.73M
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Members,
Surprise, surprise!
Our analysts have discovered a tiny float, NASDAQ-listed alert that looks like its gearing up to break to and through the $1-mark in the near-term!
Immediately turn your attention to OHRP (Ohr PharmaceuticaI, Inc.).
OHRP is a pharmaceutical company focused on the development of novel therapeutics and delivery technologies for the treatment of ocular diseases. The company is led by experienced, world-renowned, clinician scientists with proven ability to bring products to the market. Their lead clinical program, OHR-102 (Squalamine) eye drops, is a novel anti-angiogenic product that provides a non-invasive therapy which in Phase II studies has been shown to improve visual outcomes compared to the current gold standard treatments without requiring additional injections.
The company is evaluating OHR-102 eye drops, given in combination with Lucentis® (Genentech/Roche) intravitreal injections, for the treatment of retinal diseases including wet age related macular degeneration (AMD), retinal vein occlusion and diabetic retinopathy. Wet AMD is the leading cause of vision loss in the elderly, affecting over 1.75 million patients in the United States alone, and the incidence is expected to dramatically increase in the upcoming years. Data from a Phase II clinical trial in wet AMD demonstrated a positive and clinically meaningful treatment effect of OHR-102 combination therapy and the pivotal Phase III program is being initiated.
OHRP's preclinical pipeline is robust and focused on the development of sustained release therapeutics for ocular diseases utilizing our Patented Microfabrication Platform Technology. The company currently has several active programs evaluating molecules and approaches for the treatment of primary open angle glaucoma, steroid-induced glaucoma, ocular allergies, and retinal diseases. These programs have been identified by the company as large markets of unmet medical need or where sustained release therapeutics can greatly improve upon the way ocular disease is currently being treated, including increasing compliance rates and reducing treatment burden
The promise shown by OHRP's product pipeline offers a new ray of hope for patients suffering from numerous blinding ocular diseases, and Ohr’s world-class expertise surrounding the treatment of eye disorders is the key to advancing existing and Future Pipeline products.
Squalamine Clinical Trial (1601 Study/MAKO)
Squalamine is a small molecule, anti-angiogenic drug with a novel intracellular mechanism of action. The drug acts against the development of aberrant neovascularization by inhibiting multiple growth factors, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and basic fibroblast growth factor (bFGF). Clinical evidence has shown these additional growth factors play a role in angiogenesis and ocular neovascular disease. The topical formulation of Squalamine, called OHR-102, is late stage development for the treatment of neovascular diseases of the eye and the U.S. Food and Drug Administration has awarded Fast Track Designation to the program for the potential treatment of wet AMD.
In the IMPACT study, a randomized, multi-center, masked, placebo-controlled, Phase II clinical trial completed in 2015, OHR-102 demonstrated an improvement in visual function when used in combination with an anti-VEGF agent versus anti-VEGF monotherapy. In patients with classic containing choroidal neovascularization (CNV), 42% of the patients receiving OHR-102 combination therapy achieved a ≥3 line gain at nine months, as compared to 28% in the anti-VEGF monotherapy group. A three-line gain in visual acuity is important as it represents a halving of the visual angle and would mean patients were able to see a letter half the size of what they could see at the beginning of the trial. Patients in the study also achieved a mean gain in visual acuity of +10.5 letters in the OHR-102 combination arm as compared to +5.4 letters with anti-VEGF monotherapy, a clinically meaningful benefit of +5.1 letters. Similarly, additional data from another Phase II study in retinal vein occlusion (RVO) indicated that OHR-102 combination therapy resulted in increased visual acuity compared to anti-VEGF monotherapy. In both studies, there were no safety issues identified.
OHR-102 used in combination with an anti-VEGF agent may provide several potential advantages over other combination therapy approaches currently being investigated in clinical studies including:
Daily eye drop therapy compared to an additional intravitreal injections.
Inhibition of multiple growth factor pathways.
Cost advantage of manufacturing a small molecule when compared to large molecule proteins and antibodies.
Based on the data from the IMPACT study in wet AMD demonstrating a positive and clinically meaningful treatment effect of OHR-102 combination therapy, a Phase III program is being initiated
SKS Sustained Release Technology
The patented Ohr Pharmaceutical Inc. sustained release technology employs a hydrogel template approach to prepare microparticles or other configurations of prede?ned size and shape with very homogeneous size distribution. The drug release characteristics of the particles can be adjusted, providing ?exibility in controlling release rates in our drug delivery formulations. The drug loading (content) capacity of Ohr’s technology is much higher than that achieved by conventional methods and our approach allows for control of the initial release (burst) of drug. Simplicity in processing makes the hydrogel template method useful for scale-up manufacturing of these sustained release particles. The Ohr sustained release technology is compatible with hydrophilic or hydrophobic drugs, fragile biologics and can incorporate any biodegradable polymer. Drug delivery can be achieved both outside the eye (e.g. subconjunctival space) as well through intravitreal administration using a standard needle. Our programs aim to markedly enhance patient compliance, reduce treatment burden and improve visual outcomes in a number of ocular conditions including primary open angle glaucoma, steroid-induced glaucoma, ocular allergy, and retinal diseases.
Recent Development(s):
Ohr Pharmaceutical Provides Update on Ongoing Squalamine Clinical Trial in Wet-AMD
On Monday, OHRP announced that it plans to amend the ongoing clinical trial investigating Squalamine in wet-AMD (the MAKO Study) to enable efficacy analysis by the end of calendar 2017 or early 2018. The study remains a multi-center, randomized, double-masked, placebo controlled clinical trial. The subjects enrolled in the study, over 200 in total, will continue to receive their assigned study treatment of monthly Lucentis® and either Squalamine or placebo drops twice daily, and undergo scheduled visits and assessments through nine months. The primary endpoint will be an assessment of visual acuity at nine months.
“This strategic approach should provide efficacy data by year end or early next year with the goal of confirming the benefits seen in the prior Phase 2 IMPACT study,” stated Dr. Jason Slakter, CEO. “The ongoing clinical trial has prospectively enrolled the patient population identified from the IMPACT study that has the greatest potential to benefit from Squalamine combination therapy. We remain excited about the potential of Squalamine, a differentiated, topical, multi-target angiogenesis inhibitor, and believe that this is the optimal approach to help patients, maximize value for shareholders, and enhance our ongoing business development efforts.”
Dr. Slakter continued, “Following the closing of the financing today, we are funded into 2018, including the completion of our ongoing clinical trial and data readout by the end of calendar 2017 or early 2018.”
Market Outlook:
Approximately 90 percent of all AMD-related severe vision loss results from wet AMD.
11 million Americans have some form of AMD, while 1.1 million, or 10 percent, of those Americans have wet AMD.
About 200,000 new cases of wet AMD are diagnosed each year in the United States.
The future pipeline of retinal disorder drugs is promising as drug developers continue to invest heavily in novel therapeutic development programs.
Retinal disorder drug sales are expected to account for nearly $13 Billion by the end of 2016.
The market is further expected to grow at a CAGR of 6% over the next four year period, eventually accounting for over $15 Billion in revenue by the end of 2020.
Technical Analysis:
OHRP hit a new 52-week low price of $0.60 last week.
The company has since moved higher, climbing upwards of $0.78 per share today for up to a +30% gain.
OHRP has a tiny float listed at just 32.73M.
As we witnessed in the last 7 trading days, it doesn't take much for OHRP to breakout up the chart.
OHRP looks like it is just starting to gain momentum!
We feel confident that shares of OHRP will be trading over the $1-mark in the near future.
Not to mention, a return run to OHRP's 52-week high price of $4.05 would represent up to +419% in realistic upside.
The timing couldn't be better to pick up a tiny float, NASDAQ-listed alert like OHRP.
As such, don't delay another second and pull up OHRP on your trading screen right now!
(*Remember to use a Limit Order to place your trade, followed by a Stop-Loss Order to protect your gains, as well as limit possible losses.)
To learn more about OHRP, please visit their website: www.OHRPharmaceutical.com
Best Regards,
The StockRockandRoll Team
