|Minerva Reports Positive Phase 1 Data With MIN-202; Integra Launches Integra(R) Reinforcement Matrix|
|By Josh Gee|
|Wednesday, 21 January 2015 19:57|
Minerva Neurosciences, Inc. (Nasdaq:NERV) announced preliminary results from a Phase 1 clinical study showed that treatment with MIN-202, a selective orexin-2 antagonist, resulted in significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorder (MDD). Preliminary results from two additional Phase 1 studies also suggest that MIN-202 is well tolerated and possesses advantageous pharmacokinetic and pharmacodynamic features. The three Phase 1 studies were conducted by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of a collaboration to develop MIN-202 with Minerva that was facilitated by Johnson & Johnson Innovation Ltd in London.
"Treatment of sleep disorders remains a significant challenge in patients with both primary insomnia and many CNS diseases. These positive data indicate that MIN-202 could be an effective treatment able to both induce and maintain sleep," said Remy Luthringer, PhD, president and CEO of Minerva, adding "With these findings we have identified a dose range to advance this compound."
In patients with mood disorders, sleep disturbances (both insomnia and hypersomnia) have been associated with a suboptimal response to antidepressant drug (AD) therapy, an increased risk for relapse (in AD-responsive patients), and prodromal depression. Recent studies have shown that orexin-2 receptor antagonism might have a beneficial effect on overall arousal and stress level.
"We are especially encouraged by findings that support the use of MIN-202 in the treatment of both primary insomnia as well as sleep disorders associated with MDD," Dr. Luthringer added.
MIN-202 Phase 1b Study in MDD Patients -- This was a double-blind, placebo-controlled, randomized, four-way crossover, single dose study in 20 male and female patients with MDD and insomnia. The primary endpoint was the effect of MIN-202 (dosed PM) on latency to persistent sleep (LPS). Some additional endpoints were evaluated by PSG (polysomnography). Preliminary results demonstrated a statistically significant effect on LPS in all three doses tested (10, 20, and 40 mg). Treatment with MIN-202 also resulted in prolonged total sleep duration by approximately 45 minutes.
MIN-202 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers -- This was a double-blind, placebo-controlled, randomized MAD study in sequential cohorts of healthy males and females. MIN-202 was administered in the morning at dose levels ranging from 5mg to 60mg for 10 days. A dose level as low as 5mg was shown to elicit sedation while dose levels ≥ 20mg induced (daytime) somnolence. MIN-202 plasma exposure was dose proportional from 5mg to 20mg. At higher doses, the exposure was less than dose proportional.
MIN-202 Phase 1 Bio-Availability (BA) Study -- The two studies described above were carried out using a suspension formulation of MIN-202. This third study evaluated treatment with a solid dose formulation of MIN-202 to potentially support additional clinical studies. In this study, similar pharmacokinetic profiles were observed for both formulations, qualifying the solid dose to support further clinical studies. In these Phase 1 studies, MIN-202 was found to be generally well tolerated.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced the full market release of Integra® Reinforcement Matrix, a biological implant composed of porcine dermis that may be used for any type of tendon injury that requires surgical reconstruction. Tendon injuries are some of the most common musculoskeletal disorders, ranging from a mild ankle sprain to an Achilles tendon rupture or flexor tendon injury of the hand.
Manufactured by Stellen Medical, which has over 25 years' experience in working with porcine dermis, the matrix has 510 (k) clearance from the Food and Drug Administration, and is made of the same material that has over 14 years of implant success in more than 40,000 surgical procedures.
"Integra is committed to providing improved clinical solutions for our upper and lower extremity surgeon customers," said Bill Weber, Vice President, Orthopedics & Tissue Technologies. "Integra Reinforcement Matrix complements our portfolio of tendon repair products, and offers surgeons enhanced options for their patients' needs."
Integra Reinforcement Matrix has high tensile strength that provides durable reinforcement during the healing phase of a repaired tendon, and omni-directional suture pullout strength that minimizes tearing. The collagen matrix allows early cellular repopulation, remodeling and revascularization for long- term repair. The product is available in two convenient sizes, 4 cm X 7 cm and 5 cm X 10 cm, and is ready-to-use, hydrated, and does not require special handling before surgery.
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