Q&A: MediciNova Chief Business Officer David Crean on developing biopharma\” />

What are the main processes involved in taking a scientific concept and turning this into a key medical product?

David Crean, Chief Business Officer at MediciNova (Nasdaq: MNOV), a late-stage, global biopharmaceutical company that is developing novel therapeutics with a primary focus on neurodegenerative disorders, beginning with Amyotrophic Lateral Sclerosis (ALS).

Digital Journal spoke with Crean about the drug development process.

Digital Journal: Can you tell us a little bit about MediciNova?

Dr. David Crean: MediciNova is a publicly traded (dual-listed on the Nasdaq and Tokyo Stock Exchange), clinical-stage biopharmaceutical company headquartered in La Jolla, California.  We have 2 drug candidates, MN-166 and MN-001. We focus primarily on neurodegenerative diseases, with ALS as our lead program with MN-166. We also explore other areas with unmet need such as oncology, inflammatory disease, metabolic disorders, and certain rare conditions.

What defines us is our patient-first philosophy and a very pragmatic approach to drug development. Instead of starting with brand-new compounds, we have identified drugs either in late-stage development or already approved outside the US with positive safety profiles and compelling biology / mechanism of actions, then re-purposing them in high-need indications. This allows us to move faster and more efficiently into clinical trials, especially in diseases like ALS that have such high unmet need, where time is critical to provide more effective treatments to patients.

DJ: What makes MediciNova’s approach to drug development unique compared to other biotech companies?

Crean: Our approach combines speed, safety, and scientific depth. Many companies invest in early-stage discoveries, which can take years just to reach a first-in-human trial. At MediciNova, we work with established molecules that have already been administered to patients and therefore have well established safety data. That foundation allows us to focus on clinical relevance and therapeutic potential.

Our lead candidate, MN-166 or ibudilast, is a perfect example. Although it is considered a new molecular entity in the United States and Europe, it has been used for decades in Japan and South Korea to treat conditions like asthma and post-stroke complications with lower daily dosage. More than 3 million patients have safely and effectively been treated with this drug under regulatory approvals in those countries.

With an academic team’s collaboration, we identified the new mechanisms of action.  By utilizing higher daily dosage, we are applying ibudilast’s anti-inflammatory and neuroprotective properties to early-stage ALS, where chronic neuroinflammation is known to drive disease progression. That multiple mechanisms of action is what makes MN-166 unique, and why we believe it has the potential to become a disease-modifying treatment for ALS.

DJ: What indications are you targeting with your core programs and why have you chosen them?

Crean: ALS is our primary focus. This is a progressive, fatal disease that robs patients of their motor function and independence. The average life expectancy from diagnosis is just two to five years, and current therapies like riluzole or edaravone offer only modest benefits. There is a clear and urgent need for treatment that does more than temporarily address symptomology.  Our goal with MN-166 is to slow the progression of the actual disease.

We are currently conducting a pivotal phase 2b/3 study called COMBAT-ALS. This is a randomized, placebo-controlled trial in early-stage ALS patients, and we are evaluating changes in functional ability over 12 months, survival time, and quality of life. An open-label extension phase also allows all participants to receive MN-166 after the initial trial period. In fact, we recently announced nearing the end of enrollment in that study, a key milestone that we’re excited to share. We believe this trial could establish MN-166 as one of the first therapies with true disease-modifying potential in ALS.

Outside of ALS, we have been exploring MN-166 in progressive MS, chemotherapy-induced-neuropathy and degenerative cervical myelopathy through government- and institution-sponsored studies. We also have another candidate, MN-001 or tipelukast, which is being evaluated for hypertriglyceridemia in type 2 diabetes patients. This compound may offer a novel approach to reducing cardiovascular risk through multiple mechanisms and we’re excited to see the results of those studies.

DJ: What are your most recent clinical milestones and what do they mean for the diseases you’re targeting?

Crean: One of our most important recent updates is that we are nearing full enrollment in the COMBAT-ALS trial. As of early July, only a small number of patients remain to be enrolled. Once enrollment is complete, we will be tracking outcomes for 12 months, with final data expected by the end of 2026.

We also released interim analysis results last year. These showed strong positive correlations between six-month and twelve-month data, particularly on measures like the ALS Functional Revised Rating Scale and functional domains like speech, fine motor skills, and gross motor function.

In addition, we are currently supporting an NIH-funded Expanded Access Program for ALS patients who do not qualify for the traditional clinical trials. This real-world study will provide MN-166 to up to 200 patients with more advanced diseases on a compassionate care basis. It not only reflects growing interest in the drug’s potential but will also give us broader safety and efficacy data across a wider patient population.

DJ: Have you taken advantage of AI or other advanced technologies during the development process?

Crean: We are not an AI-driven company by design, but we absolutely use advanced data analytics throughout our development process. In a disease like ALS, where progression can vary widely from patient to patient, it is critical to understand which factors influence response. All of this helps us design better trials and, ultimately, develop more effective therapies.

DJ: What’s next for MediciNova?

Crean: In the months ahead, we’ll continue to focus on completing enrollment in COMBAT-ALS and our Phase 2 trial in hypertriglyceridemia in type-2 diabetes patients. Once enrollment is finalized, we will shift to preparing for data readouts. We expect those results to be a major inflection point for both programs.

For ALS specifically, we are exploring ways to further expand patient access, including additional real-world studies and potential regulatory discussions. We also plan to evaluate MN-166 in other neurodegenerative diseases where inflammation plays a central role.

Looking at the long term, for MN-166, we want to build a portfolio of inflammation-neuroprotective targeting therapies that address multiple conditions, from ALS to other neurological diseases. For MN-001, we want to build a portfolio of metabolic and cardiovascular diseases. 

 Our dual listing gives us access to both U.S. and Japanese markets, and we are actively seeking strategic partnerships that can help accelerate development and commercialization globally.

What drives us is the opportunity to bring something truly meaningful to patients. ALS remains one of the most urgent and underserved diseases in medicine. We are proud of the progress we’ve made, and we believe MN-166 has the potential to change the treatment landscape.