Erez Aminov, CEO & Chairman of the Board, and Dr. Itzchak Angel, Chief Scientific Advisor for MIRA Pharmaceuticals MIRA, were recently interviewed by Benzinga.
MIRA is a pre-clinical biopharma focused on developing treatments for neurologic and neuropsychiatric disorders. It holds exclusive rights to Ketamir-2, an oral ketamine analog being studied for neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation and PTSD.
The company's other primary asset, MIRA-55, is a novel pharmaceutical marijuana analog that could provide enhanced therapeutic effects over THC.
MIRA is a pre-clinical biopharma focused on developing treatments for neurologic and neuropsychiatric disorders. It holds exclusive rights to Ketamir-2, an oral ketamine analog being studied for neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation and PTSD.
The company's other primary asset, MIRA-55, is a novel pharmaceutical marijuana analog that could provide enhanced therapeutic effects over THC.
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NewsTranscript
00:00Welcome, Benzinga Nation.
00:03Today we've got great interviews lined up for you.
00:05We have one with Eris, who is the CEO and chairman of the board.
00:09And we've also got Dr. Angel, who is a chief scientific advisor for Mira Pharmaceuticals.
00:13Ticker on the NASDAQ is M-I-R-A.
00:16Gentlemen, welcome to the show.
00:20I'm excited to be here.
00:21You know, it's always great when we have a conversation about Ketamir and the other things
00:24that you guys are working on as well.
00:26But before we get to the details, Eris, if you could give me an overview of what Mira
00:30Pharmaceuticals is.
00:32We're developing treatments for neurologic and neuropsychiatric disorders.
00:36We're currently at the preclinical stage.
00:39We have two drug candidates, Ketamir 2 and Mira 55.
00:43I'll touch a little bit on Ketamir 2.
00:45Ketamir 2 is an oral ketamine analog.
00:48And we're developing this to treat neuropathic pain, depression, PTSD.
00:54And unlike traditional ketamine that has severe side effects, such as addiction and
01:00other safety issues, ours is an oral formulation that is a non-opioid and is designed to have
01:07high efficacy with very low safety, with a great safety profile.
01:13Our other drug candidate, Mira 55, is a marijuana analog.
01:18And that is being developed to treat anxiety and cognitive decline.
01:25And the key differentiator between marijuana and our drug is that, unlike marijuana that
01:30impairs your cognition, our compound, Mira 55, has been shown to double memory in preclinical
01:36models.
01:37Now, Dr. Angel, when it comes to like mental health, that's such a big, big key thing that
01:42a lot of people in America and around the world worry about.
01:45How does Ketamir 2 differ from the traditional ketamine?
01:49And more importantly, what advantages does it offer regarding, say, safety, efficacy,
01:54or the administration aspect of it as well?
01:56Well, Ketamir 2 is a new drug with a very unique mechanism of action and a profile.
02:03The key points that I can outline in which it is different from classical ketamine is,
02:10first of all, it's oral bioavailability.
02:13Whereas ketamine has to be given parenterally, namely by injection, ketamine is active orally.
02:22And this makes a very big difference.
02:24In addition, ketamine has a lot of issues related to its safety profile, abuse potential,
02:33and for that, it's a regulated compound.
02:37Whereas ketamir is a very selective compound, does not have a side effect so far, and is
02:44not a regulated product.
02:47In addition, the profile of ketamine is such that it restricted very much its activity,
02:55although it is active in a variety of cases.
02:59Ketamir 2, on the other hand, has a very similar profile without a side effect, but also we
03:06know that it acts in a very specific site and what we call the NMDA receptor, and it
03:13does not interact with many of those activities that we see ketamine to be active.
03:19So we are expecting to have a very unique, very safe use, which would not be regulated
03:26and which be orally available.
03:29You know, I think it's important to note the oral aspect of it as well.
03:32I think that's key for people to easily be able to take the medicine in.
03:37Why neuropathic pain, however?
03:40Is this like a underserved aspect of it?
03:42What kind of market opportunity exists, Dr. Angel, in this area?
03:46Well, neuropathic pain is very common.
03:49Many people, particularly diabetic patient, people that have shingles, people with other
03:56viral infections, but also people that are treated by chemotherapy, like cancer treatment,
04:03would suffer from neuropathic pain.
04:06Neuropathic pain is a result of some damage of nerves, somatosensory nerve, what we call,
04:15and it is manifested by increased sensitivity to even to touch or to pain.
04:22And these people would have durable, lengthy, chronic sensation of, it could be just pain,
04:34sensitivity to touch, sometimes tingling.
04:37But this may go up to lack of sensation in the feet or the hands.
04:43And this is a very big problem, particularly considering that there are several opportunities
04:50as drug or acupuncture or some other therapies, but those therapies are often associated
04:56with side effects and they give answer only to a small proportion of those suffering patients.
05:05Now what would you say to people who want to know what makes Ketamir 2 novel, though?
05:09Ketamir 2, as I said before, it is novel in terms of its mechanism of action.
05:15I can say that its similarity to ketamine gives us confidence that the drug would be
05:20effective even before we do the trial.
05:24But we found in some of our animal trials, a surprising effect where we were able to
05:32demonstrate that by oral doses of Ketamir 2, we reach a lack of hypersensitivity altogether.
05:42And at very low doses, we saw very significant effect on the model, a very severe model
05:50of neuropathic pain.
05:53We are currently exploring more of different types of model of neuropathic pain, just to
05:59understand the breadth and the amplitude of the different activities.
06:05But we think this would be a very unique and very safe treatment for neuropathic pain.
06:09Dr. Engel, thank you for the insights there.
06:12Erez, you know, where is Ketamir 2 in the development pipeline?
06:17Because say, you know, everything goes well.
06:19If all things go well, when would you hope to hit the markets?
06:23So it's coming right up.
06:24We have our IND being submitted in December.
06:28And as early as next year in January, we anticipate to start our phase one clinical trials.
06:35If everything goes as planned, we're looking at a three to four year timeline before this
06:40drug can hit the market.
06:41So we're very close to getting to that target point.
06:45I'm already excited to talk to you in the first quarter of 2025 to see how things are going.
06:49Dr. Engel, are you incorporating AI at all in your research and how so?
06:55And if you're not at the moment, I'm curious if you hope to, in the future, integrate AI
07:00in your research.
07:01In fact, we are incorporating AI in our program.
07:05In fact, very early on in the initial trials with Ketamir 2, we have employed some AI oriented
07:13programs, for example, to predict some of the potential interaction of Ketamir 2.
07:24And we have used a broad database in order to use machine learning technologies in order
07:31for those activities to predict its activity.
07:36Subsequently, we have confirmed some of those AI induced prediction with empiric testing.
07:44And we are on a very regular basis using AI technologies to improve our planning and to
07:51improve our understanding of the potential pharmacological activities and the potential
07:56profile of such a compound, which is innovative like Ketamir 2.
08:02You know, AI, whether it's for simplicity of the emails I need to edit or to do research
08:06like you're doing, it always comes into play.
08:09Speaking of like technologies and the landscapes that are changing in that aspect, let's talk
08:13money, Aris.
08:14How have you seen like the funding landscape shift over, say, the last year or so for biotech
08:20pharma?
08:21It's a very good question.
08:23And investors have become more selective.
08:26They're focusing on companies that have solid data, innovative solutions, and everyone wants
08:32to make sure that they're addressing a significant unmet need.
08:35And that's exactly what Mira Pharmaceutical is doing.
08:39We're innovating.
08:40We have solutions to address significant unmet needs such as neuropathic pain, depression,
08:46treatment resistant depression with suicidal ideation, as well as ongoing studies to evaluate
08:51PTSD.
08:53However, capital is still available for companies such as Mira Pharmaceuticals.
08:59And we're looking at a potential breakthrough therapy here that could change the way patients
09:06are being treated moving forward.
09:09And we're very excited to be a part of this.
09:12And then, you know, Dr. Angel, you mentioned alternative clinical indications such as PTSD.
09:19How do you view their integration into your current development plan?
09:23Well, we are starting, as I said, we are in the stage where we are compiling all the regulatory
09:30requirement for the IND.
09:34And those studies are going very smoothly.
09:36So we would be able to submit an IND later by December this year.
09:43But we would start very traditionally with a classical phase one clinical trial.
09:48However, in parallel, we are investigating the potential of Ketamine 2 in alternative
09:54indications such as PTSD.
09:57PTSD is a huge and unmet need and also a huge market.
10:02And then subsequently, once we go through the first stages, we may want to integrate
10:09additional potential indication like PTSD or some rare disease that may be
10:19amnable for orphan drug designation.
10:22And we believe that at a later stage, this may enhance our arrival into the market beyond
10:29the one that Erez has mentioned.
10:32So this would be done in parallel, but this may give us some benefit in going quicker
10:38into the market.
10:39PTSD, another big thing that a lot of Americans deal with, especially the one who serves.
10:45So it's great to hear that you guys are working on that.
10:47Last question for you, Erez, given your current development timeline that we've talked
10:51about, when can we expect initial efficacy results in human trials for Ketamine 2?
10:58Well, with the help of Dr.
10:59Angel and our scientific team, we're putting together a strategic phase one, phase two
11:04study design and results can come as early as 2025 in humans.
11:09Yeah, I've been saying it throughout the interview.
11:11I think PTSD, anxiety, depression, things that so many people around the world deal
11:15with. And I'm happy to hear that you two and your company Mira Pharmaceuticals is
11:19working on that. So thank you for that and also for your time here today.
11:24You got it.
11:25That is Erez, who is a CEO and chairman of the board.
11:27And Dr.
11:28Angel, who is the chief scientific advisor for Mira Pharmaceuticals, ticker on the NASDAQ
11:33is M-I-R-A.