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Menlo Therapeutics marching ahead with its Phase 2 clinical trial in Pruritis

30 Sep Menlo Therapeutics marching ahead with its Phase 2 clinical trial in Pruritis

Menlo Therapeutics (NASDAQ: MNLO), a late-stage biopharmaceutical company, has announced the completion of enrollment of patients in a crucial phase 2 clinical trial for studying the efficacy and safety of once daily oral serlopitant for the treatment of Chronic Pruritus (itch) of Unknown Origin (CPUO). The company’s lead candidate Serlopitant, is a small molecule, highly selective NK1 receptor antagonist, which directly targets the two most critical receptors responsible for the origin of the itch-scratch reflex namely Substance P and the neurokinin-1 receptor.

Itching is a natural response that is meant to protect the body from harmful objects in the environment such as insect bites. However it can also occur due to an underlying, undiagnosed medical condition and in some cases lasts for more than 6 weeks, leading to it being characterized as Chronic Pruritus of Unknown Origin or idiopathic Pruritis. The incidence of this illness is extremely high in the elderly population, with over two million patients suffering from this condition as per the company. Serlopitant, if approved, will be the first therapeutic developed for this population.

The enrollment in the trail was initiated in Q1 of 2019, with patients who have a history of pruritis with no underlying cause. The trial is a multicenter, placebo-controlled , double-blind study that will evaluate the effect of serlopitant in the reduction of pruritus, as compared to a placebo over a ten-week treatment period. The results will be measured on a 4-point responder analysis on the worst-itch numeric rating scale (WI-NRS), the standard measure of itch.

Steve Basta, chief executive officer of Menlo Therapeutics states

“The rapid enrollment in this trial reflects the high unmet need in the CPUO patient population. We were able to enroll 233 patients in approximately nine months, reflecting the significant motivation of these patients to seek treatment for this condition. CPUO is one of three pruritus indications we are currently pursuing with our novel, highly selective small molecule NK1 receptor antagonist, including our ongoing Phase 3 Prurigo Nodularis (PN) and Phase 3-ready Psoriasis pruritus programs.” 

The company expects to announce the results from the trial by Q1 of 2020, with plans to report the results from its two ongoing Prurigo Nodularis (PN) phase 3 trials in H1 of 2020. Consequently based on the results of the trial, the company will file for an NDA for Pruritis associated with Prurigo Nodularis (PN) by late 2020 as per a company statement.

Menlo Therapeutics, (NASDAQ: MNLO)

Market Cap: $106.83M; Current Share Price: 4.46 USDChart
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Pruritus is characterized by an uncomfortable and persistent urge to scratch caused either due to a skin disorder or an underlying systemic disease such as atopic dermatitis, mycoses, chickenpox, hepatitis, Jaundice, chronic renal failure, cholestasis or NASH. These can be chronic in nature and affect the quality of life of those suffering from it.

The current treatment plan for Pruritus involves the prescription of antihistamines, topical corticosteroids, opioid receptor antagonists, topical immunomodulators, antidepressants, neuroepinephrine re-uptake inhibitor (SNRI) and cannabinoid receptors to name a few. The use of the above treatment options come with their own set of adverse side-effects, such as shortness of breath, dry mouth, blurred vision, erythmea, wheezing, allergic reactions or a rash.

The global market for Pruritus therapeutics stood at USD 11.09 Billion in 2018 and is likely to grow at a CAGR of 6.2 percent to reach USD 17.99 Billion 2026 according to a report by reports and data. The growing incidences of skin ailments, upcoming patent expiration, increasing regulatory support, strategic mergers, partnerships and collaborations between key players are likely to drive the growth in the market.

However the adverse side-effects of the drugs and availability of photo therapy may limit the growth prospects. The discovery of small molecules, TRP Channel Antagonists, Peptide based treatments are some of the novel innovations that seek to address the unmet needs in this area.

Menlo Therapeutics is engaged in developing Serlopitant, a highly selective, once-daily, oral small molecule inhibitor of the neurokinin 1 receptor, or NK1R for the treatment of Pruritis. It directly works on two important mediators of the urge to itch namely substance P, a naturally occurring peptide in the tachykinin neuropeptide family and its receptor neurokinin-1 receptor, or NK1-R. The binding of SP to NK1-R is the key reason behind nerve-signalling including itch-scratch reflex and the vomiting reflex.

This late stage biopharmaceutical company aims to focus on creating a solution for Pruritus and sees a great commercial opportunity as currently there are no therapies available to exclusively target this disease in the U.S. It has been granted a FDA breakthrough designation and plans to file for an Investigational New Drug Application (IND) in 2020.

Image Source: Company

It holds exclusive, royalty-free rights to develop and commercialize Serlopitant in all markets. Its pipeline consists of the application of Serlopitant in the treatment of Prurigo Nodularis Itch, Psoriasis Itch and Chronic Pruritus of Unkown origin which are in various stages of clinical development.

Furthermore it holds intellectual property rights to composition of matter in the U.S including extensions and methods of use which will offer it protection until 2030.

Risk Assessment

  • The Pruritis drug space offers immense potential as there are no FDA approved therapies; however previous attempts at developing therapeutics have failed, which is a major cause for concern, especially since the company’s pipeline is solely focused on Serlopitant, which is extremely risky. While a successful completion of clinical trials will bolster its revenues and earnings, any delay or failure to meet clinical end points in the trial will adversely affect the company.
  • As per its second quarter 2019 financial results, Menlo had $109.4 million in cash, cash equivalents and investments, compared to $136.3 million as of December 31, 2018. In the second quarter of 2019, Menlo issued 246,416 shares of its common stock pursuant to its at-the-market program at an average price of $7.84 per share and received aggregate net proceeds of $1.9 million after deducting sales agent fees. The company has sufficient funds to advance its clinical trials and meet the anticipated operating expenses and capital expenditure requirements into the first quarter of 2021.
  • The company has decided to defer the start of a Phase 3 clinical program in pruritus associated with psoriasis until 2020. While this allows Menlo to focus exclusively on its current clinical trials, it also means that it is delaying a potential revenue stream.
  • The company is yet to enter into any strategic partnerships, collaboration or licensing agreements. These are of great importance for clinical-stage firms, not only for funding the pipeline but also to leverage on regulatory and marketing expertise from more established players in the market. Such arrangements will also help the company expand into developing markets globally and navigate the regulatory environment more efficiently.
  • Conclusion
    We believe that the company will be able to emerge as a leader in the pruritis space, owing to its focus and strategy to address an area with large unmet medical needs. There is no effective treatment for pruritis, and if Menlo is successful in proving the efficacy of Serlopitant, then it has a winner at hand. 

    Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any position within the next 72 hours.

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