The BIO One-on-One Partnering System has been working overtime with 15 percent more requests than the previous year! With the BIO International Convention now officially a week away, we’re featuring another presenting company in our Snapshot Series. We spoke to Trigemina, and you can find their responses below. And catch their presentation Monday, 4/22 at 2:00 p.m. in the Chicago Cubs Room, located right outside the main entrance of the BIO Business Forum.
What is your company’s lead product or technology?
Our lead molecule is TI-001, a proprietary formulation of intranasal oxytocin for head pain, protected by five issued US and European patents, with similar intellectual property (IP) in various stages of prosecution throughout the world. TI-001 addresses one of the most urgent global needs in drug development: an alternative to current opioid pain drugs and a safe and effective, entirely new, migraine therapeutic.
Preclinical studies on TI-001 show promising results, with the potential to be a highly effective therapy for a wide range of chronic and subacute head pain indications. In addition, early placebo-controlled clinical studies have demonstrated powerful pain reduction in chronic migraine, a multi-billion dollar market by itself. Moreover, doctors are already familiar with oxytocin, which has been used to safely induce labor and lactation in pregnant and nursing women for more than 60 years. Because of this, doctors are quite comfortable with its safety profile, insuring rapid market penetration upon the approval of TI-001.
How does your company go about differentiating itself from the competition?
Chronic migraine is a devastating disease where patients have at least 15 headache days per month. According to a Wells-Fargo analysis, there are approximately six million chronic migraine sufferers in the US alone. Currently, BOTOX injections are the only approved treatment for chronic migraine, producing only a slight decrease in the frequency of headaches experienced, while having no effect on reducing the severity.
Trigemina’s early clinical results suggest robust effectiveness in this same population; for example, 27% of patients reported zero pain after treatment with TI-001, and 50% of patients had a least a 50% reduction in pain, compared to zero and 22% of the placebo treated patients, respectively.
Trigemina is kicking off a Phase II study on TI-001 for the treatment of chronic migraine, which is scheduled to be complete in Q4, 2013. We are confident that the results of this study will demonstrate that our new formulation, TI-001, is highly effective in relieving chronic migraine pain, as well as the nausea, photophobia, and phonophobia that come with it. These results should also be emblematic of the potential of TI-001 for the treatment of multiple chronic and sub-acute craniofacial pain states, including post-procedural pain, head cancer pain, temporomandibular joint pain, and chronic tension-type headaches.
What are the short-term and long-term priorities for your company?
Our current focus is the conduct of our proof of concept Phase 2a/b clinical trial, scheduled to commence in Q2 2013. In a randomized, double blind, placebo-controlled eight week trial, we will provide conclusive data regarding TI-001’s safety and effectiveness in chronic migraine, as well as provide dosing information. This trial, TRIG-05, is intended to provide all of the key information needed for the design of an appropriate Phase 3 registration trial. Our goal is to gain FDA approval of TI-001 for chronic migraine in early 2015. Given the very extensive and positive safety history of the oxytocin molecule, we think that this is a realistic goal.
In parallel, Trigemina continues to work on improved formulations to enable enhanced composition of matter intellectual property and extend patent life.
Tell us something about your company attendees of the BIO International Convention may not know?
Dave Yeomans, Ph.D, is a professor and the director of pain research at Stanford University School of Medicine. In this position he is a central point through which a large number of innovative new drug ideas generated by Stanford faculty flow, as well as a font of new ideas for pain management.
His brother, Charles Yeomans, was the first investor in Trigemina and has a background on Wall Street and as CEO of a consulting organization dealing with health insurance, which has given him an understanding of the payers and how they work. In 2011, when Trigemina was seeking additional capital and a new CEO, the Trigemina board recruited Charles to assume that role, making this the first time the brothers had worked together since they built a go-kart.
Charles recently added Mike Leonard to the team as CFO/COO, who was the CFO at his prior company and whose experience includes 150+ mergers and acquisition transactions and capital raises.
What are your goals for the event?
We have two principal goals in attending BIO. We would like, on a preliminary basis, to speak with potential pharma partners who can help us move our drug through a Phase 3 clinical trial and the FDA registration process. We are a small company with an excellent, but limited, clinical development team. Although we are passionate about our lead molecule, we are also realistic in our understanding of the capabilities required to move a drug through the later stages of the approval process. We think we have a game-changer, and we would like to find a partner who has a level of enthusiasm and commitment comparable to ours but who has much greater capacities. We are also exploring potential venture funding upon completion of our clinical trial as an alternative to partnering, but believe in the partnering model as our most favored approach. With regards to the Business Forum, we hope to enhance exposure of the biotech community to the Trigemina story. Dr. Yeomans will be giving the presentation and will make clear the potential impact of TI-001 to the medical community.
Is there a story behind your company name or logo?
Trigemina, which means “three bodies,” is named for the trigeminal neural system, which is responsible for carrying pain information from the head and face toward the brain. This neural pathway is also where TI-001 works to produce craniofacial analgesia. We like the name a lot and think that it tells a story just in itself. Our logo is a stylized triangle – again bringing in the idea of three bodies working together.
Thank you to the Trigemina team for being a part of this event! Find them in the BIO One-on-One Partnering System here, and schedule your meeting!