Image Credit: Piction health (MIT News)

Startup Lets Doctors Classify Skin Conditions with the Snap of a Picture

Zach Winn | MIT News Office

At the age of 22, when Susan Conover wanted to get a strange-looking mole checked out, she was told it would take three months to see a dermatologist. When the mole was finally removed and biopsied, doctors determined it was cancerous. At the time, no one could be sure the cancer hadn’t spread to other parts of her body — the difference between stage 2 and stage 3 or 4 melanoma.

Thankfully, the mole ended up being confined to one spot. But the experience launched Conover into the world of skin diseases and dermatology. After exploring those topics and possible technological solutions in MIT’s System Design and Management graduate program, Conover founded Piction Health.

Piction Health began as a mobile app that used artificial intelligence to recognize melanoma from images. Over time, however, Conover realized that other skin conditions make up the vast majority of cases physicians and dermatologists see. Today, Conover and her co-founder Pranav Kuber focus on helping physicians identify and manage the most common skin conditions — including rashes like eczema, acne, and shingles — and plan to partner with a company to help diagnose skin cancers down the line.

“All these other conditions are the ones that are often referred to dermatology, and dermatologists become frustrated because they’d prefer to be spending time on skin cancer cases or other conditions that need their help,” Conover says. “We realized we needed to pivot away from skin cancer in order to help skin cancer patients see the dermatologist faster.”

After primary care physicians take a photo of a patient’s skin condition, Piction’s app shows images of similar skin presentations. Piction also helps physicians differentiate between the conditions they most suspect to make better care decisions for the patient.

Conover says Piction can reduce the time it takes physicians to evaluate a case by around 30 percent. It can also help physicians refer a patient to a dermatologist more quickly for special cases they’re not confident in managing. More broadly, Conover is focused on helping health organizations reduce costs related to unnecessary revisits, ineffective prescriptions, and unnecessary referrals.

So far, more than 50 physicians have used Piction’s product, and the company has established partnerships with several organizations, including a well-known defense organization that had two employees diagnosed with late-stage melanoma recently after they couldn’t see a dermatologist right away.

“A lot of people don’t realize that it’s really hard to see a dermatologist — it can take three to six months — and with the pandemic it’s never been a worse time to try to see a dermatologist,” Conover says.

 

Shocked into Action

At the time of Conover’s melanoma diagnosis, she had recently earned a bachelor’s degree in mechanical engineering from the University of Texas at Austin. But she didn’t do a deep dive into dermatology until she needed a thesis topic for her master’s at MIT.

“It was just a really scary experience,” Conover says of her melanoma. “I consider myself very lucky because I learned at MIT that there’s a huge number of people with skin problems every year, two-thirds of those people go into primary care to get help, and about half of those cases are misdiagnosed because these providers don’t have as much training in dermatology.”

Conover first began exploring the idea of starting a company to diagnose melanoma during the Nuts and Bolts of Founding New Ventures course offered over MIT’s Independent Activities Period in 2015. She also went through the IDEAS Social Innovation Challenge and the MIT $100K Entrepreneurship Competition while building her system. After graduation, she spent a year at MIT as a Catalyst Fellow in the MIT linQ program, where she worked in the lab of Martha Gray, the J.W. Kieckhefer Professor of Health Sciences and Technology and a member of MIT’s Institute for Medical Engineering and Science (IMES).

Through MIT’s Venture Mentoring Service, Conover also went through the I-Corps program, where she continued to speak with stakeholders. Through those conversations, she learned that skin rashes like psoriasis, eczema, and rosacea account for the vast majority of skin problems seen by primary care physicians.

Meanwhile, while public health campaigns have focused on the importance of protection from the sun, public knowledge around conditions like shingles, which effects up to 1 percent of Americans each year, is severely lacking.

Although training a machine-learning model to recognize a myriad of diverse conditions would be more difficult than training a model to recognize melanoma, Conover’s small team decided that was the best path forward.

“We decided it’s better to just jump to making the full product, even though it sounded scary and huge: a product that identifies all different rashes across multiple body parts and skin tones and age groups,” Conover says.

The leap required Piction to establish data partnerships with hundreds of dermatologists in countries around the world during the pandemic. Conover says Piction now has the world’s largest dataset of rashes, containing over 1 million photos taken by dermatologists in 18 countries.

“We focused on getting photos of different skin tones, as many skin tones are underrepresented even in medical literature and teaching,” Conover says. “Providers don’t always learn how all the different skin tones can present conditions, so our representative database is a substantial statement about our commitment to health equity.”

Conover says Piction’s image database helps doctors evaluate conditions more accurately in primary care. After a provider has determined the most likely condition, Piction presents physicians with information on treatment options for each condition.

“This front-line primary care environment is the ideal place for our innovation because they care for patients with skin conditions every day,” Conover says.

 

Helping Doctors at Scale

Conover is constantly reminded of the need for her system from family and friends, who have taken to sending her pictures of their skin condition for advice. Recently, Conover’s friend developed shingles, a disease that can advance quickly and can cause blindness if it spreads to certain locations on the body. A doctor misdiagnosed the shingles on her forehead as a spider bite and prescribed the wrong medication. The shingles got worse and caused ear and scalp pain before the friend went to the emergency room and received the proper treatment.

 

“It was one of those moments where we thought, ‘If only physicians had the right tools,’” Conover says. “The PCP jumped to what she thought the problem was but didn’t build the full list of potential conditions and narrow from there.”

Piction will be launching several additional pilots this year. Down the line, Conover wants to add capabilities to identify and evaluate wounds and infectious diseases that are more common in other parts of the world, like leprosy. By partnering with nonprofit groups, the company also hopes to bring its solution to doctors in low-resource settings.

“This has potential to become a full diagnostic tool in the future,” Conover says. “I just don’t want anyone to feel the way I felt when I had my first diagnosis, and I want other people like me to be able to get the care they need at the right time and move on with their lives.”

Reprinted with permission of MIT News” and a link to the MIT News homepage ( http://news.mit.edu/)

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Tonix Pharmaceuticals Announces Development of TNX-601 ER, a Potential Abuse Deterrent, Extended-Release Formulation of Tianeptine Oxalate for the Treatment of Major Depressive Disorder

Research, News, and Market Data on Tonix Pharmaceuticals

Naloxone-Free
Formulation of Tianeptine is an Extended-Release Tablet that Includes Inactive
Ingredients and Compression Properties Designed to Confer Abuse Deterrence

Once-Daily Tablet Formulation
of Tianeptine is Bioequivalent to the Three Times a Day Antidepressant Marketed
in Europe for Over 30 years

Tianeptine’s Enhancement of
Neuroplasticity in Animal Models of Stress Implies a Distinct Indirect
Glutamatergic Mechanism of Action Relative to Antidepressants Marketed in the
U.S.

Planning to Initiate Enrollment
in U.S. Phase 2 Study in First Quarter 2023, Pending FDA Clearance of IND

CHATHAM, N.J., July 11, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced development of TNX-601 ER (tianeptine oxalate extended-release tablets), a naloxone-free formulation of TNX-601 designed to confer abuse-deterrence, for the treatment of major depressive disorder (MDD)¹. Tonix expects to initiate a Phase 2 study of TNX-601 ER for the treatment of MDD in the first quarter of 2023, pending U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application.

Tonix’s TNX-601 ER is being developed as a treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America for the treatment of MDD over the more than three decades since it was first marketed in France in 1989. No tianeptine-containing product has been approved by the FDA. The proposed mechanism of action of TNX-601 ER is distinct from traditional monoaminergic antidepressants in the U.S. In addition to its glutamatergic properties central to its antidepressant effect, tianeptine has weak µ-opioid receptor agonist properties and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD². Previously, Tonix was developing a naloxone-containing tablet, TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse.

“TNX-601 ER is a naloxone-free tablet formulated with inactive ingredients that we believe will make the tablet more difficult to adulterate for misuse and abuse, while maintaining extended-release characteristics, even if the tablet is subjected to physical manipulation, and/or chemical extraction,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “The potentially abuse deterrent ingredients include gel forming polymers which impede extraction, and excipients which cause nasal irritation. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which hinders efforts to misuse by insufflation or intravenous routes.”

“The efficacy of tianeptine sodium IR is comparable to both selective serotonin inhibitor (SSRI) and tricyclic antidepressants
^3,4 while being associated with a low incidence of sexual dysfunction than either of those classes^5,6, and no associated derangement of sleep architecture, sedation effects, weight gain, or cognitive impairment,⁷” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Given tianeptine’s unique metabolic pathway, which is independent of the hepatic P450 system, we believe that TNX-601 ER has a reduced risk of drug-drug interactions compared to most antidepressants⁷. Tianeptine’s antidepressant activity is believed to relate to indirect modulation of the glutamatergic system. While it does not have measurable interactions with the NMDA, AMPA or kainate receptors, tianeptine is known to modulate AMPA receptor trafficking and to promote synaptic plasticity in hippocampus under conditions of stress or corticosteroid use. In animal models, tianeptine restores neuroplasticity and reverses stress-induced impairments in synaptic glutamate neurotransmission, which are perturbed in depression.⁸ Additionally, TNX-601 ER is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day dosing of the immediate-release sodium salt products available in Europe and other jurisdictions around the world.”

¹TNX-601 ER is in the pre-IND (Investigational New Drug) stage of development and is not approved for any indication

²Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–553.

³Jeon, H. J., et al. .J. Clin. Psychopharmacol. 2014, 34 (2), 218–225.

⁴Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
⁵Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
⁶Costa e Silva, J. A., et al. Neuropsychobiology 1997, 35 (1), 24–29.

⁷Wagstaff, A. J. et al. CNS
Drugs 2001, 15 (3), 231–259.

⁸McEwen, B. S., et al. Mol.
Psychiatry 2010, 15 (3), 237–249.

About Depression
According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode¹, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.^2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.⁴

¹Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from 
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
²IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.
³Kubitz N, et al. (2013)  PLOS One,. 8(10):e76882. doi: 10.1371/journal.pone.0076882. PMID: 24204694;
⁴Rush AJ, et al. (2007) Am J.
Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER
TNX-601 ER is a novel oral formulation of tianeptine oxalate designed for once-daily daytime dosing that is in the pre-IND (Investigational New Drug) stage of development for the treatment of MDD. Tonix reported the official minutes of an FDA Pre-IND meeting on March 22, 2021. Tianeptine sodium (amorphous) immediate release (3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restoring hippocampal long-term potentiation and reversing the neuroplastic changes from stress and corticosteroid exposure. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists, that present a potential abuse liability if illicitly misused in large quantities (8-80 times the therapeutic dose). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated¹ suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks^2,3,4–6, 3-months⁷, or 12-months⁸ of treatment. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder. TNX-601 ER is expected to have patent protection through 2037.   

¹Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.

²Emsley, R., et al. J. Clin.
Psychiatry 2018, 79 (4)
³Bonierbale M, et al. Curr Med
Res Opin 2003, 19(2):114-124.⁴Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.

⁵Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.

⁶Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.

⁷Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.

⁸Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

Tonix
Pharmaceuticals Holding Corp. ^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. TNX-601 ER (tianeptine oxalate extended-release tablet) is being developed as an antidepressant in the U.S., with a Phase 2 study expected to be initiated in first quarter of 2023 pending IND clearance. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of
Tonix’s product candidates are investigational new drugs or biologics and have
not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward
Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR

peter.vozzo@westwicke.com

(443) 213-0505

 

Source: Tonix Pharmaceuticals Holding Corp.

Monday, July 11, 2022

Ortho Regenerative Technologies Inc. (ORTIF)
Heal Better; Initiating Coverage with an Outperform Rating

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Unmet large market needs. Ortho Regenerative Technologies Inc. (Ortho RTI) is advancing its RESTORE regenerative medicine platform in rotator cuff tears and meniscus tears to improve healing. Rotator cuff and meniscus tears have high failure rates due to insufficient healing and tissue degeneration. For these two indications, Ortho RTI has a $1.8 billion US market opportunity. Globally, the market opportunity more than doubles. Additional future applications expand the opportunity further.

Safe and easy to produce. The proprietary RESTORE platform is a biopolymer matrix technology combining readily available chitosan, derived principally in shellfish, with autologous platelet-rich plasma (PRP). Using the patient’s own plasma substantially improves the safety profile while the chitosan provides site “stickiness”.

…

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.